EU Medicines Agencies Network Strategy to 2020...The lack of availability of medicines is considered...

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1 2 17 February 2016 3 Version 3.0 4 5 6 7

EU Medicines Agencies Network Strategy to 2020 8

Heads of Medicines Agencies (HMA) Multi-annual Work Plan 9

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Contents 10

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Chapter 1 – Introduction ............................................................................................. 3 12

Chapter 2 – Approach to the strategy......................................................................... 4 13

Chapter 3 – Strategy for the network.......................................................................... 6 14

Theme 1: Contributing to human health .................................................................. 6 15

Theme 2: Contributing to animal health and human health in relation to veterinary 16

medicines ............................................................................................................. 19 17

Theme 3: Optimising the operation of the network ............................................... 31 18

Theme 4: Contributing to the global regulatory environment ................................ 42 19

Glossary ............................................................................................................... 50 20

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Chapter 1 – Introduction 23

24 The Heads of Medicines Agencies (HMA) is a network of the Heads of National Competent 25 Authorities whose organisations are responsible for the regulation of medicinal products for 26 human and veterinary use in the European Economic Area. The HMA and European 27 Medicines Agency (EMA) have developed a joint high level strategy (HLS) for the network 28 until 2020 inclusive, the ‘EU Medicines Agencies Network Strategy’. The HLS outlines joint 29 priorities for the network and how to achieve these. It also reflects the need for a 30 coordinated approach to address the multiple challenges and opportunities that face the 31 network. 32 33 This multi-annual work plan (MAWP) sets out how the work of the HMA will be focused on 34 delivery of the objectives set out in the HLS. The National Competent Authorities of the 35 Member States of the EU and the European Free Trade Association (EFTA) have a variety 36 of responsibilities including scientific assessment and are brought together through the HMA. 37 The HMA works closely with the EMA, as the EMA has a key role in scientific coordination 38 and National Competent Authorities are responsible for the scientific assessment and 39 scientific advice. The HLS is an important tool for ensuring that all parts of the EU network 40 are aligned in terms of key priorities over the next 5 years. In order to achieve the common 41 goals of the HLS, separate but coordinated MAWPs/implementation plans have been 42 produced for each of the other components of the network including EMA and CMDh. The 43 MAWP encompasses both human and veterinary medicines. 44 45 The members of CMDh (the Coordination group for Mutual recognition and Decentralised 46 procedure – human) are, formally, appointed by the Member States of the EU. However, in 47 practice, they are experts of the National Agencies of the Member States and the resource 48 to run the procedures of the CMDh are provided through HMA. It is therefore important that 49 the CMDh multiannual work plan is closely aligned with that of the HMA, and is therefore 50 included as an annex to this document. On the veterinary side, CMDv (the Coordination 51 group for Mutual recognition and Decentralised procedure – veterinary) performs a similar 52 function to CMDh and its multiannual work plan has also been included as an annex to this 53 document. 54 55 The MAWP is based around the four strategic themes set out in the HLS which have been 56 broken down into action areas. Within the action areas, the MAWP sets out the goals we 57 want to achieve and provides details on individual actions planned and how these support 58 the wider strategic approach that we are taking. Regular reviews of progress will be 59 conducted during the lifetime of this programme against these individual actions and against 60 the overarching action areas. 61 62 Close cooperation between the HMA and its delivery partners (such as the EMA) will be a 63 key factor in the successful delivery of HLS. Effective communication and sharing of 64 information across the network is also a core part of the MAWP. The HMA will also engage 65 with other key stakeholders outside the network to develop action areas within the MAWP. 66

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Chapter 2 – Approach to the strategy 68

69 This MAWP describes specifically how all the National Competent Authorities within the 70 HMA will take forward the elements of the Network Strategy. It identifies the leads and 71 timings in each of the action areas, how the HMA is approaching each objective and how the 72 objectives contribute to the HLS. 73 74 The HMA Management Group (HMA MG) will play a key role in ensuring delivery of the 75 MAWP, through oversight of the working groups and task forces of the HMA who will take 76 forward the actions identified in the MAWP. The HMA MG will report to the HMA meetings 77 on progress made against the MAWP and, from its oversight of the working groups, will be 78 able to advise on which of the identified strategic priorities should be discussed at which 79 HMA meeting, where the focus will be on the key priorities. Within the network, the HMA 80 MG will work with the EMA MB to identify areas of collaboration and sustainability. 81 82 The HLS highlights the need to work globally both at a practical level and in responding to 83 global themes which have an impact on regulators. This will include working with other 84 world-wide regulators on areas such as global inspection to improve global harmonisation, 85 for instance through the work of the International Coalition of Medicines Regulatory 86 Authorities (ICMRA) on the human side. Therefore this MAWP describes the ways in which 87 the network will work internationally to take forward the relevant items of the strategy. There 88 will be knock on benefits from this including contributing to global public health, assisting in 89 expanding the network’s expertise and promoting European scientific approaches as a 90 possible model for multinational collaboration. 91 92 One of the important elements covered in the MAWP is how the HMA itself functions, 93 including the operation of its meetings, to enable it to focus on the key elements of the 94 Strategy. It will seek to improve strategic direction and insight which will be critical in 95 delivering the strategy. Therefore this plan, in addition to describing how the strategy will be 96 taken forward, describes the key priorities that are at the heart of delivering the vision for an 97 optimised network. HMA have evaluated all of the actions from the four strategic themes in 98 the HLS and agreed priorities within each theme which have been consolidated into eleven 99 key business priorities. These agreed business priorities will contribute to both animal and 100 human health and bring together a number of the individual actions from within the strategy. 101 They will have designated leads within the HMA and will be an important focus of future 102 HMA meetings. 103 104 The eleven key business priorities are as follows: 105 106

Antimicrobial resistance 107 Availability of appropriately authorised medicines 108 Competence development programme through the EU Network Training Centre 109 Developing an efficient, effective and collaborative approach on inspections to 110

address sustainability 111 Innovation and access to new medicines 112 International collaboration 113 Implementation of the telematics strategy 114 Optimisation of the regulatory operations 115 Responding to public and animal health emergencies. 116 Strengthen surveillance 117 Support for better use of medicine 118

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119 Whilst this plan describes many of the key areas of work over the coming years, it inevitably 120 will not cover the complete spectrum of work done by the NCAs/HMA, or the routine work 121 that must continue. 122

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Chapter 3 – Strategy for the network

Theme 1: Contributing to human health

Introduction

Contributing to human health and welfare is a main task of the Network and one of the primary motivations of NCA staff. NCAs are well placed with their nationally rooted expertise to play a key role in leading the evaluation of any issue related to the benefits/risks of medicines and also collaborating with other bodies in exploring pharmaceutical solutions to human health threats. Furthermore, NCAs’ position in the Network should facilitate both bottom-up identification of problems that might need a harmonised approach and top-down implementation of European positions at the Member States level.

The HLS proposed four strategic objectives for the network to contribute to human health; where appropriate we have identified the working areas of focus under objectives:

1. Focus on key public health priorities including medicinal product availability and antimicrobial resistance o Availability of authorised medicinal products: shortages o Support in the case of Public Health Emergency issues o Antimicrobial Resistance

2. Ensure timely access to new beneficial and safe medicines for patients 3. Support for patient focused innovation and contribute to a vibrant research driven life science sector in Europe

o Promoting an adequate environment for innovation and research in Europe 4. Strengthen regulatory capability and transparency

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Objective 1: Focus on key public health priorities including medicines availability and antimicrobial resistance

Our approach

The Network must be prepared to detect and jointly address a variety of real or potential public health challenges and emergencies. These emergencies may arise either from the use of medicinal products already marketed within the EU or from the necessity to find new medicines to treat novel infectious diseases or other health threats.

Contribution to HLS

The regulation of medicinal products must have a focused approach to react to the challenges that may arise at any time in relation to medicines, whether related to the availability (timely access, shortages, sunset clause) or any identified event (safety) that might require the intervention of the authorities and the provision of adequate information to the public.

The HMA will ensure that effective coordination between the NCA resources is achieved in order to optimise the national resources in the best interest of public health. This relates to key issues such as the identification and management of events related to already authorised products and the establishment of an environment that facilitates the investigation, development and authorisation of new innovative medicinal products in the EU, which is of special relevance in the case of unmet medical needs and major threats for the health of EU citizens.

In addition, it is important to highlight that to achieve this objective there is a need for HMA to focus on firmly maintaining its commitment to confronting the potential threat of antimicrobial resistance as a key part of its public health priorities.

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Goal 1.1 - Availability of authorized medicinal products: Shortages

HMA faces the challenge ever more frequently of availability problems of already approved medicines that either never reach the market or which become no longer available either on a temporary or permeant basis.

The lack of availability of medicines can both affect single Member States or became a European wide problem involving a number of countries. Although the origin of these shortages can be mainly related to supply issues, HMA should also consider additional factors including economic interests.

The lack of availability of medicines is considered as a priority for HMA and has to be confronted from a global perspective.

Action Lead Performance indicators Timeline

1. Further collaboration among Member States by exchanging information and best practices on the management of shortages, ensuring early identification, and a rapid and harmonised evaluation and response to any new event that may potentially lead to a shortage. Specifically, foster collaboration of GXP inspector working group (plus CMDh/CMDv and EMA) to minimise supply challenges and shortages.

New subgroup on Availability with involvement from CMDh/CMDv

HMA Priority - Availability of appropriately authorised medicines:

Has progress been made towards:

i. early identification of shortages and medicinal products that may be at risk of shortage

ii. a common repository for sharing such information on the HMA website

iii. adoption of preventive measures by regulators

iv. optimisation of communication tools to the general public and health care professionals

v. monitoring the number of shortages due to supply chain and manufacturing problems? (yes/no)

MEDIUM

2. Identification of valuable old or niche products that fulfil medical need which, although not considered innovative and without a commercial interest for the industry, may have a critical relevance for the Health systems and patient care and therefore require enhanced support.

New subgroup on Availability with involvement from CMDh/CMDv


Is there an agreement on a list of “old” valuable medicines at risk of disappearing? (yes/no)

MEDIUM

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Goal 1.2 - Support in the case of Public Health Emergency issues

HMA has the challenge of being preparing for and also responding to public health emergencies in relation to the identification, management and communication of threats. The lessons learnt following the handling of the Ebola crisis have to be taken forward for the future.


3. Develop appropriate ways to rapidly communicate and share information between Member States in emergency cases and new diseases status such as the Ebola crisis, working with the incident review network. Coordinate resources for assessment in the event of public health emergencies.

HMA MG nominees to work with EMA IRN

HMA Priority – Responding to public and animal health emergencies:

Working with the EMA conduct a review of the incident review network. Has a reflection exercise been completed and have lessons learned been published after crises like Ebola? (yes/no)

SHORT

4. HMA should ensure the qualification of representative and proactively rehearse scenarios so it can respond rapidly when addressing the regulatory aspects of the availability of scarce essential medicinal products during health emergencies.

HMA MG / Incident risk committee

HMA Priority – Responding to public and animal health emergencies:

Has the potential for a procedure to exchange medicines during health crisis been explored? (yes/no)

MEDIUM

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Goal 1.3 - Antimicrobial Resistance

HMA remains committed to confronting the potential threat of antimicrobial resistance. Specific actions of the HMA Task Force on Antimicrobial Resistance such as ensuring close working with the Task Force on legislation to help inform negotiating positions on antibiotic issues and keep exploring ways in which to best implement the action plan on AMR may contribute to progress in this matter.


5. The implementation of the EU Commission Action Plan, international collaboration and contribution to the implementation of the WHO plan to combat the rising threat of antimicrobial resistance are maintained as established objectives for HMA.

HMA Task Force on Antimicrobial Resistance to include close interaction with EMA

HMA Priority - Antimicrobial resistance:

Number of action plans on AMR implemented in Member states. (figure)

Number of best practices identified and shared at the HMA level. (figure)

MEDIUM/LONG

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Objective 2: Ensure timely access to new beneficial and safe medicines for patients

Our approach

The Network should respond to the increasing demand of timely access to new and promising medicines by striking the correct balance between the regulatory requirements demanded and length of time before they are available for patients.

Contribution to HLS

The HMA will ensure the establishment of an effective environment that facilitates the investigation, development and authorisation of a broad range of different types of new innovative medicinal products in the EU. Coordination between Member States is essential for the early identification of novel developments or medicines that must be supported by the system to the patients’ benefit. The coordinated management of both the national and European available tools for facilitating the access to the new medicines has to be explored.

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Goal 2.1 - Ensure timely access to new beneficial and safe medicines for patients HMA has established the priority of ensuring an appropriate regulatory environment for the earlier access to novel medicines of value.

For the achievement of this objective, HMA is actively involved in the pilot project on Adaptive Pathways. HMA should play a key role in allowing these valuable regulatory tools for the early access to be integrated in the system in the best interest of patients.

Such system can only work with the active involvement of the HTA, pricing and reimbursement bodies and payers from the Member States.


6. HMA should further explore the flexibilities that the EU regulatory framework offers for the early access of innovative products at national level. i.e. the participation in clinical trials (either phase II, phase III or expanded access clinical trials), compassionate use (either named-patient basis or cohort basis approaches), or off-label use as well as contributing to the further optimisation of conditional approval, exceptional circumstances approval or accelerated assessment (pathfinder support scheme) through the participation in the STAMP group and support to prime/adaptive pathways.

HMA Subgroup on Timely Access

HMA Priority - Innovation and access to new medicines:

Has there been a publication on HMA website of national programmes and contribution to early access through compassionate use? (yes/no)

Has there been regular feedback to HMA on the participation in STAMP/PRIME? (yes/no)

Is there evidence of bilateral communication HMA-STAMP for progress of the objective? (yes/no)

MEDIUM

7. In conjunction with EMA explore ways to harmonize the regulatory requirements of registries and defining circumstances for use of real world data (RWD) that may be potentially used in the authorisation or modification of marketing authorisations.

Leader (mentor) to be assigned by HMA MG and/or HMA Subgroup on Timely Access


Have common agreements been reached for the requirements for national registries and circumstances where RWD is an appropriate data source to support products in different phases of their life cycle? (yes/no)

MEDIUM

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8. HMA will work in the following years to explore how to improve the involvement of patients/users, Health Care professionals and academic community in those regulatory activities which have an impact on them or on which they can influence. Moreover, the collaboration with other key bodies (such as HTAs, pricing and reimbursement authorities and payers) has to be reinforced to enable appropriate decision making and exchange of information to allow optimal market access.

Communications group for patient input

HMA Timely Access subgroup for work with HTA, payers and P&R authorities HCP and academic community


Number of HMA interactions with patients/users at national and EU level, Health Care professionals and academic community through stakeholders meetings. (figure)

Has there been an assessment of the impact of any measure taken by the system to facilitate the collaboration with HTA/pricing & reimbursement bodies? (yes/no)

MEDIUM

9. HMA should maintain an active position to facilitate the entry of generics and biosimilars into the market as a way to facilitate patient care (more patients able to receive treatments) and sustainability (more patients at the same cost and new innovative treatments).

CMDh/CMDv

Working with EMA on biosimilars


Has there been promotion of the 'work-sharing' of the assessment of Bioequivalence studies, ASMF, etc. included in the MAA of generics? (yes/no)

Has the possibility of reduced timetables for the assessment of such products been explored? (yes/no)

SHORT

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Objective 3: Support for patient focused innovation and contribute to a vibrant life science sector in Europe

Our approach

HMA should contribute to support innovations that represent value for patients. However, it should also be recognised that, most times, innovation occurs step by step and that the only way to promote valuable innovation is maintaining a dynamic life science sector. Thus, HMA is also committed to create those conditions under its scope in the EU that favour the growth of a strong, vibrant and brilliant life sciences sector.

Contribution to HLS

HMA should enable those national activities with high impact on drug development including clinical trials, scientific advice or the activity of the national innovation offices, to be aligned and designed to favour the development of new medicines of value to society. The coordination of resources is again vital for the attainment of this objective.

Goal 3.1 - Promoting an adequate environment for innovation and research in Europe The promotion of an adequate environment for innovation as well as the facilitation of the research in Europe must be considered as an objective for the coming years. HMA considers that putting in place mechanisms for horizon scanning and collaboration procedures within the EU can contribute to the promotion of innovation in Member States. This is indeed in relation to the established priority of ensuring timely access to new beneficial and safe medicines for patients. HMA will keep providing scientific and technical support through the participation of national experts on the EMA activities. The involvement of NCAs in the timely access is essential to assure the continuity of these EU actions at national level and the final access of patients to novel medicines. In addition, HMA remains committed to contribute to research in the EU by facilitating the implementation and optimisation of the legal framework established with the new Clinical Trial Regulation for the benefit of the patients and investigators. The activity of the HMA Clinical Trial Facilitation Group will be crucial for the achievement of this objective. The implementation of such legislation during the coming years will contribute to reduce obstacles that may delay or complicate the application, evaluation, authorisation and conduct of clinical trials in the EU as well as the achievement of the transparency goal in this field. The collaboration of HMA for the identification of promising developments and novel research fields at national level will be essential for the good functioning of the timely access programmes. This contribution will be managed through the advice procedure and the activity of the national innovation offices.

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Action Lead Performance indicators Timeline 10. Promote the involvement and collaboration

of HMA on the Innovative Medicines Initiative (IMI) projects.

HMA MG HMA Priority - Innovation and access to new medicine:

Have steps been made to reinforce the bilateral relation between HMA and IMI? (yes/no)

Have IMI been invited to HMA meetings? (yes/no)

Number of IMI projects that MS are involved with. (figure)

SHORT

11. Support a coordinated and integrated view of NCAs’ innovation offices and EMA’s Innovation Task Force particularly in relation to the early identification of promising developments and its integration in the EU adaptive pathways, national designation of small and medium enterprises (SMEs) as well as investigate the possibility to establish harmonised criteria for borderline products.

Finland as Chair of Innovation TF

HMA Priority - Innovation and access to new medicine:

Has there been an implementation of mechanisms of coordination between national agencies in relation to the functioning innovation agencies? (yes/no)

Is there a shared plan and criteria for NCAs’ innovation offices and EMA’s Innovation Task Force? (yes/no)

Has there been a measurement of the impact of the measures taken for the coordination of the national innovation offices activities? (yes/no)

MEDIUM

12. HMA must strengthen the voluntary harmonization procedure (VHP) which has proven to be a relevant tool for the rapid authorisation of clinical trials within the EU territory, also ensuring the consistency and harmonisation in decision making.

Chairs of HMA Clinical Trial Facilitation Group – Mentor Xavier De Cuyper


Are there indicators that measure the use of the VHP procedures? (yes/no)

SHORT

13. HMA will contribute to the harmonised application of the new Clinical Trials regulation and ensure it is introduced in a timely way that reduces the bureaucracy currently associated with trials.

HMA Clinical Trial Facilitation Group


Has there been a clear common identification and definition of the low interventional studies? (yes/no)

Number of trials done in Europe before and after change in legislation. (figure)

MEDIUM

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Objective 4: Strengthen regulatory capability and transparency

Our approach

We, as regulators, must be as sophisticated as the sector we regulate. The system must ensure their adaptive capacity to the regulatory changes and emerging needs that may arise at any time.

Contribution to HLS

Facilitation of medicines registration is a declared objective. HMA will continue searching for simplification, agreements and common ground between countries in relation to the requirements and procedures for the approval of medicines. The enhancement and improvement of existing tools such as the DC/MR procedures (decentralised/ mutual recognition) and the achievement of agreements on issues still unresolved as the common criteria for the authorisation of over-the-counter (OTC) products remain as HMA objectives. HMA considers that the work of CMDh is essential for the achievement of this goal. The proactive vigilance of the medicinal products available in the EU market is maintained as commitment of HMA. NCA should ensure the optimisation of both resources and systems to comply with this objective.

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Goal 4.1 - Strengthen regulatory capability and facilitating the regulatory system The continuous training of assessors and regulators will be imperative to further promote these capabilities on development of innovative products and technologies. HMA should promote a system that is able to adequately respond to the development of innovative technologies and systems such as individualized medicines, nanomedicines or gene/cell technologies. The role of the EU Network Training Centre (EU NTC) is considered essential for the achievement of this objective as well as ensuring equitable contribution of all Member States to the system. In relation to the objective of facilitating the registration and maintenance of medicines, HMA, in collaboration with both the CMDh and CMDv and through the Task Force in relation to timetables, have to keep improving the MR/DC authorisation procedures for medicinal products as necessary.


14. HMA should consider the necessity, feasibility and capability of the agencies to generate independent data or reanalyse raw data on issues necessary to ensure the reliability of regulatory outcome.

Timely Access subgroup

HMA Priority: Availability of appropriately authorised medicines:

Has an analysis of situations and circumstances been conducted in which it would be more appropriate to generate independent data or reanalyse raw data. Development of guidance if applicable? (yes/no)

Have experiences on reviewing of the raw data reanalysis carried out by individual agencies, cases, needs and results been shared? (yes/no)

Has there been an analysis of the national/EU programs aimed at generating independent data? (yes/no)

LONG

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15. HMA will continuously explore harmonisation of criteria and removing of unnecessary national requirement to reduce the administrative burden of the registration processes in Member states.

CMDh/CMDv HMA Priority – Optimisation of the regulatory operations:

Number of national requirements removed through harmonized procedures. (figure)

MEDIUM

16. HMA will explore other ways to reach agreements between Member states regarding non-prescription products, to facilitate a greater number of product switches.

CMDh to report back to HMA

HMA Priority: Availability of appropriately authorised medicines:

Creation of creating a subgroup/working group aimed at exploring common agreements for individual active substances or other solution? (yes/no)

MEDIUM

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Theme 2: Contributing to animal health and human health in relation to veterinary medicines

Introduction

One of the key tasks of the next five years for the Network is the contribution to the finalisation and implementation of the legal framework for

veterinary medicines with the objective of reducing the administrative burden for both the NCAs and the industry whilst maintaining an

appropriate oversight to ensure protection of animal health, public health and the environment.

The Network must collaborate to find innovative ways to support change and handle challenges such as Internet commerce, new technologies,

disharmonised aging products, product availability for MUMS (minor use minor species) or for small markets.

The Network has a key role in supporting the joint strategy and One Health approach to minimise the risk to human health and animal health

that may arise from the use of antimicrobials in veterinary medicine.


1. Increase availability of veterinary medicines and promote development of innovative medicines and new technologies

o Increasing availability in Veterinary Medicinal Products

2. Promote “Better Regulation”*

o Reductions of administrative burdens

o Legislation

o Pharmacovigilance

3. Improve the functioning of the single market for veterinary medicines within the EU

o Harmonisation in the Network

4. Focus on key public and animal health priorities including antimicrobial resistance

o Communication

o Regulation of Medicines focused on the public health needs

o Efficiencies of the system

* Better Regulation" means designing EU policies and laws so that they achieve their objectives at minimum cost. Better Regulation is not about regulating or deregulating. It is

a way of working to ensure that political decisions are prepared in an open, transparent manner, informed by the best available evidence and backed by the comprehensive

involvement of stakeholders. This is necessary to ensure that the Union's interventions respect the overarching principles of subsidiary and proportionality i.e. acting only

where necessary and in a way that does not go beyond what is needed to resolve the problem [http://ec.europa.eu/smart-regulation/guidelines/ug_chap1_en.htm]

http://ec.europa.eu/smart-regulation/guidelines/ug_chap1_en.htm

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Objective 1: Increase availability of veterinary medicines and promote development of innovative medicines and new technologies

Our approach

Ensure the network has structures and systems in place to safeguard the continuing availability of older products of critical importance

to animal health.

Ensure that network has the necessary infrastructure and systems in place to respond to new technological developments.

Contribution to HLS

The network will strive to promote an increase in the availability of various types of veterinary medicine, giving particular attention to

products indicated for minor use in major species and for minor species (MUMS), as well as smaller national markets, and for technologies

that are new to the veterinary domain.

Goal 1.1 – Increasing availability of Veterinary Medicinal Products


17. Establish a joint HMA/EMA initiative to

promote the availability of veterinary

vaccines focussing in particular on vaccines

for minor use or for minor species, to

protect human health in terms of

transmission of zoonoses (including AMR),

and to encourage the development of

vaccines that could be used as alternatives

to antibiotic therapy.

SG on

veterinary

vaccines

HMA Priority - Antimicrobial resistance:

Has there been input from Network experts into

considerations by CVMP of:

i. revision of MUMS guidelines

ii. the need for new/revised guidance on the benefit

risk assessment of vaccines for use in particular

situations such as new disease or epizooties, for

zoonotic infections and when used as

alternatives to antibiotics

iii. the need to revise guidance on vaccines against

epizootic disease (FMD, Bluetongue) and the

multi-strain dossier approach? (yes/no)

LONG

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18. Develop strategy and action plan on the

feasibility of cooperating to support the

retention on the market of ‘old’ veterinary

antimicrobials that are critically relevant for

animal health by harmonising SPCs and by

fostering the generation of efficacy data.

AMR TF HMA Priority - Antimicrobial resistance:

Strategy and action plan developed at HMA/CMDv level?

(yes/no)

SHORT

19. Develop the use of the European Union

Database of VMPs to underpin the

requirement of the proposed legislation for a

European database of authorised veterinary

medicinal products and to facilitate

veterinarians’ application of the provisions

of the Cascade (a risk based decision-tree

to help decisions on product use when no

authorised medicines are available).

TMB HMA Priority: Optimisation of the regulatory

operations:

Number of Member States that have submitted data to

Eudrapharm Vet. (figure)

MEDIUM

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Objective 2: Promote “Better Regulation”

Our approach

HMA will build on current systems for work-sharing and will strive for improved operation of the procedures and the optimal use of resources in

the network, while awaiting the implementation of the new legislation, by for example:

CMDv to continue to work to reach harmonised views and continue to support improvement of current system

NCAs will continue to realise efficiencies through the work-sharing of PSURs and variations.

HMA will plan for any new structures needed to support the legislative requirements and work with EU Commission and other

stakeholders to elaborate and implement structures necessary to support the proposed Regulation on VMPs.

HMA will strive to realise the legislative vision through proactive engagement in its implementation.

Contribution to HLS

The network will reduce the regulatory burden on the veterinary pharmaceutical industry to the greatest extent possible whilst at the same time

maintaining the existing, high standards for the protection of human and animal health and of the environment and without transferring the

burden to the competent authorities.

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Goal 2.1 - Reductions of administrative burdens


20. To reduce administrative burdens and

maximise the shared use of resources

across the network.

CMDv & ESS HMA Priority - Optimisation of the regulatory

operations:

Have CMDv promoted the use of work sharing for

variations and reported on the numbers of requests

received annually? (yes/no)

Have CMDv developed a summary table recording areas

where there have been:

i. direct reduction in burdens

ii. indirect reductions on burdens

iii. use of cross network resources? (yes/no)

Have ESS promoted the use of work sharing for PSURs

and reported annually? (yes/no)

MEDIUM

21. Continue to look for ways to help achieve

harmonisation and consistency of approach

for example promote the use of electronic

submissions to reduce any unnecessary

national requirements associated with e-

submissions, including at validation.

CMDv/HMA MG

to assign leader

HMA Priority - Optimisation of the regulatory

operations:

For e-validation and e-submissions: has the number of

Member States accepting electronic submission each

year been published? (yes/no)

Has a database been developed and categorised of

referral outcomes and best practices for the NTC for

online use? (yes/no)

MEDIUM

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Goal 2.2 – Legislation


22. Communicate with Industry to improve their

regulatory understanding in the operation of

the MRP and DCP so that scientific

resources are prioritised for the most

important issues.

CMDv / HMA

MG to assign

lead

HMA Priority - Optimisation of the regulatory

operations:

Have HMA/CMDv hosted an interested parties meeting

with outcomes then made available on HMA website?

(yes/no)

Is there evidence of increased feedback and

collaboration in the development of CMDv guidance

documents on regulatory aspects? (yes/no)

Has the Notice to Applicants guidance been revised?

(yes/no)

MEDIUM

23. Ensure that the experience of the EU

Network is represented in discussions on

proposed regulation.

NCAs HMA Priority - Optimisation of the regulatory

operations:

Have NCAs provided input via their representatives in the

Council and other bodies as appropriate? (yes/no)

SHORT

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Goal 2.3 – Pharmacovigilance


24. Optimise the process for veterinary

pharmacovigilance, increasing the use of IT

tools to improve efficiency and

effectiveness. Explore how to improve

interactions with veterinary professionals to

increase PV reporting rates, particularly in

the area of livestock medicines.

PhVWG ESS

(The European

Surveillance

Strategy (ESS)

group for

veterinary

medicinal

products)

HMA Priority - Strengthen surveillance:

Identified opportunities for interaction with stakeholders

to explore reasons for low reporting rates by

veterinarians? (yes/no)

Is there evidence of an increase in reporting rates across

all species? (yes/no)

MEDIUM

25. Preparation for the revised processes and

IT systems including a VICH-compliant

Union pharmacovigilance system as

envisaged in the proposed legislation and

liaison with industry on the resulting

impacts and new ways of working.

ESS/ PhVWP HMA Priority - Optimisation of the regulatory

operations:

Has there been a review of the requirements of the

proposed legislation with processes introduced as

appropriate? (yes/no)

Has a solution been identified through the EU telematics

programme that meets the needs of the Network in a

cost effective way? (yes/no)

MEDIUM/LONG

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Objective 3: Improve the functioning of the single market for veterinary medicines within the EU

Our approach

Optimise existing opportunities for harmonisation under the current legislation

Ensure that any delegated or implementing measures required by the new European legislation fully take account of NCAs perspectives

Build on existing systems, including EU networks (including NTC) and IT systems

CMDv to continue to explore solutions to issues identified

Review work-sharing experiences to identify opportunities for improvement

Contribution to HLS

The network will seek to maximise the use of the existing legal framework to promote the effective functioning of the single market for

veterinary medicines. This will include the availability of veterinary medicines in smaller national markets.

Goal 3.1 – Harmonisation in the Network


26. Consider the challenges and opportunities

of the internet market through a dialogue

between member states on experience

gained, including on the implementation

and outcomes of regulatory tools that have

been put in place already at a national level

such as Accredited Internet Retailer

schemes.

ESS/ CMDv HMA Priority - Strengthen surveillance:

Has there been a Workshop on the regulation of internet

markets in the Community? (yes/no)

Number of multi-lingual packages across the EU and

increased availability of products in small markets.

(figure)

SHORT/

MEDIUM

27. To work with the Quality Review of

Documents Group to ensure harmonisation

in order to facilitate multi-lingual packages,

especially in minor markets.

CMDv HMA Priority – Support better use of medicines

Number of multi-lingual packages across the EU. (figure)

Is there evidence of increased availability of products in

small markets? (yes/no)

SHORT/

MEDIUM

27

28. Take advantage of every opportunity to

consider or offer harmonisation of national

products, for example, CMDv to work with

industry to encourage conversion of

national products to EU status following a

harmonisation referral (art 34) or in defined

circumstances encourage mutual

recognition procedure (MRP) to reduce the

number of nationally only authorised

products.

CMDv HMA Priority – Optimisation of the regulatory

operations:

Has there been follow up with MAH of products subject to

an Article 34 referral within three weeks of the CVMP

opinion to offer the opportunity to convert to MRP status

after publication of the Commission decision? (yes/no)

SHORT/

MEDIUM

28

Objective 4: Focus on key public and animal health priorities including antimicrobial resistance

Our approach

Ensure the tools foreseen by the revised legislation are appropriately tailored to meet the needs of the sector

Provide input into global developments on the appropriate regulatory requirements for veterinary medicinal products.

Continue the development of ESVAC in the elaboration of species benchmarks for antibiotic consumption.

Coordinate intelligence and ensure harmonised response to issues affecting the global supply of veterinary medicinal products.

Contribution to HLS

The network will continue to be prepared to address public and animal health emergencies and priorities including supply issues. With respect

to the use of antimicrobials in veterinary medicine the aim of the network will be to minimise to the greatest extent possible the risks arising

from their use in animals, whilst ensuring that sufficient antimicrobials remain available to aid in assuring a continued high level of animal health

and to support food security, recognising in particular that ‘healthy food comes from healthy animals’.

Goal 4.1 – Communication


29. Continue to provide and promote guidance

on responsible use for classes of

antimicrobials, particularly antibiotics used

in veterinary medicines in line with CVMP

strategy on antimicrobials and, through

Union referral procedures where necessary,

ensure this is reflected in the summary of

product characteristics (SPCs) and labelling

of these products.


Number of MS communication plans in place to address

AMR in the veterinary field. (figure)

MEDIUM

29

Goal 4.2 – Regulation of Medicines focuses on the public health needs


30. The European Surveillance of Veterinary

Antimicrobial Consumption (ESVAC)

project will continue to publish an annual

report on sales of veterinary antimicrobials

throughout the EU based on data submitted

by Member States. ESVAC support NCAs

in fostering the development within their

Member States of harmonised methods for

collection of data on actual consumption of

antibiotics by different species and

categories of food producing species.


Number of NCAs submitting data on sales of

antimicrobials in required format to ESVAC (target

100%). (figure)

Number of Member States who have developed the

systems necessary to submit data on consumption per

species based on standardised templates and protocols

provided by ESVAC (target 70% by 2020). (figure)

SHORT/

MEDIUM/

LONG

31. The network will continue to monitor

developments in relation to the use of

antibiotics in animals, the development of

antibiotics resistance and the transmission

pathways between animals and humans, in

order to better evaluate the risks to animal

and public health and to target control

measures.


Completed collation of all MS actions and developments?

(yes/no)

LONG

32. The network will ensure that potential risks

to the environment from human or

veterinary medicines are addressed in a

cooperative and concerted manner. Risks

will be assessed taking into account the

opinion of other European Agencies.

NCAs/ ESS

(change to ToR

needed)

HMA Priority – Availability of appropriately

authorised medicines:

Has the network discussed and agreed a position in

relation to developing issues related to any new

environmental concerns? (yes/no)

LONG

30

Goal 4.4 – Efficiencies of the system


33. The network will improve collaboration in

case of supply disruptions or shortages for

veterinary medicines that affect multiple

Member States for example when GMP /

CEP or pharmacovigilance issues are

identified in order to understand the

potential impact on the product and its

availability. The network will coordinate

involvement of GxP inspector working

group as well as the participation of the

CMDv and EMA to minimise supply

challenges and product shortages.

CMDv/ ESS HMA Priority – Availability of appropriately

authorised medicines:

Number of events suitable for harmonized evaluation and

response managed and diffusion of information to NCAs.

(figure)

Is there a procedure in place to ensure that the HMA

website will function as a tool with up to date

information? (yes/no)

Has the CMDh Best Practice Guide on collaboration

between Member States been adapted in relation to

serious GMP non-compliance issues to the veterinary

domain? (yes/no)

Has the number of shortages due to supply chain and

manufacturing problems been monitored? (yes/no)

MEDIUM

34. Further improve the process between

Member States of evaluation,

communication and response to any

major new event, or information that might

lead to a significant change in the

benefit/risk balance of VMPs (quality,

efficacy, pharmacovigilance/safety, new

disease issues).

ESS HMA Priority – Responding to public and animal

health emergencies:

Has the network Incident Management Plan been

reviewed to ensure that its scope and content is

appropriate for all types of incident? (yes/no)

MEDIUM

31

Theme 3: Optimising the operation of the network

Introduction

The European regulatory network has the task of ensuring that it involves all parties to improve health collaboratively in relation to its work and ensuring that it has the capacity and capability to meet future challenges. The network therefore must actively assess and identify how it remains a network of excellence. Communication and links both within and outside the network must be strengthened to support the network in reinforcing its collaborative approach. One of the key tools in delivering an improvement to the network will be the regular HMA meetings and the review of the operation of these meetings will be an integral component alongside the production of this multiannual work plan. The efficiency and effectiveness of the regulatory environment is now a key factor in a global setting and the contribution to legislative changes at an EU level alongside the optimisation of the regulatory framework within the current legislative provision will contribute to successfully implementing this strategy.


1. Reinforce the scientific and regulatory capacity and capability of the network 2. Strive for operational excellence

o Optimising the regulatory operations o Reduce the administrative burden o A network which is operationally efficient and cost effective, minimising as much as possible the administrative burden for the

pharmaceutical industry and other stakeholders o A network which is sustainable and able to cope with future challenges o Strive for operational excellence

3. Ensure effective communication of and within the network o Strengthen public and political trust in the work of the authorities and the network o Ensure effective communication of and within the network (including strengthening links with EMA communications),

strengthening the role of national communications teams and links between them (WGCP), joint campaigns e.g. internet sales 4. Strengthen the links with other authorities and with stakeholders

o Foster trust with other authorities and with stakeholders

32

Objective 1: Reinforce the scientific and regulatory capacity and capability of the network

Our approach

The HMA should improve its own current capacity and capability to face future challenges. This can be achieved by identifying gaps in scientific and regulatory expertise and capacity via horizon scanning, addressing findings from the BEMA programme, and any gaps identified by the different HMA working groups and looking at how they can be filled through the EU network training centre. It will develop a forward looking strategic approach to ensure that there is appropriate expertise developed to address current tasks, emerging issues and trends. Capacity can be addressed by ensuring efficiency of the system, as well as resource and sustainability planning.

Contribution to HLS

A continued fit for purpose scientific and regulatory capacity and capability of the network will support the overall operation of the network. It will support future sustainability under ever-increasing pressure on human and financial resources as well as changing nature of products we regulate. It will support an overall network which can respond to future public health challenges.

Goal 1.1 - Reinforce the scientific and regulatory capacity and capability of the network


35. Further development of the competence development programme (through the EU Network Training Centre) - clear identification of gaps including skills for the assessment of innovative therapies of the future.

Network Training Centre

HMA Priority – Competence development programme through the EU Network Training Centre: Is there a need for an active programme of training addressing identified gaps (yes/no) Do we have a programme installed to address gaps (yes/no)

MEDIUM

33

36. Ensure identification and communication of emerging issues and trends through coordinated horizon scanning; ensure appropriate expertise is developed to address different future environments.

Innovation Network ESS

HMA Priority – Competence development programme through the EU Network Training Centre: Has a comprehensive identification of novel and emerging areas in national scientific advice and Phase I clinical trial data taken place. (yes/ no) Have the outcomes of this identification been communicated to the network. (yes/no) Make sure the revised legislation on veterinary medicines is appropriate for emerging areas and has been considered by the Network and appropriate plans put in place. (yes/no)

MEDIUM

37. To ensure active BEMA and JAP programmes exist and address deficiencies.

Compliance Group of IWP (JAP) BEMA SG

HMA Priority – Optimisation of the regulatory operations: Improved BEMA scores/ increased number of JAP audits, tracking of issues in JAP. (yes/no)

MEDIUM/LONG

34

Objective 2: Strive for operational excellence

Our approach

The network operates in a complex environment with complex procedures. Two elements are important – the quality of output and the process by which it is achieved. It should therefore review its processes to see if they can be simplified and ensure appropriate peer review of output to ensure quality is maintained. In the delivery of this objective the HMA network will ensure that long term sustainability remains an integrated thread to all of the individual actions.

Contribution to HLS

The HMA will develop actions to ensure that it maintains the quality of output within the network and ensure that it is underpinned by an improved IT service and systems. The network must take maximum value from sharing best practice and strive for continuous improvement if the overall network operation is to be as efficient as possible. A focus on its own improvement will ensure that it remains an effective component of the overall network and will strive to provide an example of best practice.

Goal 2.1 - Optimising the regulatory operations


38. Initiate efficiency review of HMA procedures to be overseen by relevant HMA group. Establish range of process improvement initiatives for HMA tracking tools and oversight covering both quantitative and qualitative aspects.

HMA MG HMA Priority – Optimisation of the regulatory operations: Has the HMA MG initiated an efficiency review of HMA procedures to be carried out by the respective HMA group (e.g. CMDh, CMDv, CTFG). (yes/no) Has a plan been developed for increasing process efficiency and harmonisation of business processes in relation to ICT and VICH developments? (yes/no) Has there been HMA plenary discussion on efficiency of processes?

MEDIUM

35

Goal 2.2 - Reduce the administrative burden


39. Optimisation of regulatory framework within the current legislative provisions, including continuing to collaborate to reduce regulatory burden where appropriate. Improve mechanisms for dialogue between Member States on burden reduction and capture and understand the needs and expectations of the network’s stakeholders.

CMD role HMA Priority - Optimisation of the regulatory operations: Have there been regular meetings with stakeholders at an EU level to discuss burden reduction? (yes/no) Has an action plan of identified key of areas been developed? (yes/no)

MEDIUM/ LONG

40. Contribute thinking to any proposed legislative changes at EU level, exploring how best this can be taken forward to ensure a proportionate and effective legal framework for the regulation of medicines. Dialogue with the European Commission (based on their work programme – revision of legislation coming up) where the HMA sees the possibilities/need for improvement. Achieving, where possible, a single position from the MS to take forward in negotiations.

HMA MG lead and plenary discussion.

HMA Priority – Optimisation of the regulatory operations: Number of common HMA positions developed? (figure) Number of common HMA positions communicated? (figure) Number of common HMA positions successfully implemented? (figure)

MEDIUM/ LONG

41. Collaborate with HTA bodies/ pricing and reimbursement authorities to ensure development programmes are designed, as far as possible, to meet the needs of all parties.

New subgroup on Timely Access

HMA Priority - Optimisation of the regulatory operations: Has a plan been developed, how to engage HTA bodies and Pricing and Reimbursement Authorities? (yes/no) Approaches made to HTA bodies and Pricing and Reimbursement Authorities. (yes/no) Agreement to common priority areas with HTA bodies and PRA reached? (yes/no)

MEDIUM

36

Goal 2.3 – A network which is operationally efficient and cost effective, minimising as much as possible the administrative burden for the pharmaceutical industry and other stakeholders


42. Improve the sharing of best practice and encourage continuous improvement, including through active participation in BEMA (Benchmarking of the European Medicines Agencies). Promoting more transparency on outcomes of BEMA processes.

BEMA SG HMA Priority – Optimisation of the regulatory operations: Is there clear evidence of continuous improvement in relation to the numbers of shared best practices? (yes/no)

MEDIUM

Goal 2.4 – A network which is sustainable and able to cope with future challenges


43. Effective use of IT systems at national and EU level to maximise efficiency and minimise burdens through taking a strategic approach across the network (EU telematics, CESP).

EU Telematics Management Board HMA Telematics steering group

HMA Priority – Implementation of the Telematics strategy: Is there evidence of increased satisfaction with IT amongst HMA? (yes/no) Has a questionnaire been developed to be sent to NCA IT heads? (yes/no)

MEDIUM/LONG

44. Effective assessment, through the data gathering initiative of: resources required across the network to inform decisions; fees to be charged to the industry and with the aim of continuously improving processes and ensuring sustainability.

HMA taskforce – Sustainability of the Network

HMA Priority – Optimisation of the regulatory operations: Has an understanding of the resources required across the network been developed? (yes/no)

MEDIUM

37

Goal 2.5 – Strive for operational excellence


45. Exploring optimisation/extend scope of work-sharing on non-centralised work.

Respective working groups

HMA Priority – Optimisation of the regulatory operations: Have work-sharing options been identified? (yes/no) Have additional work-sharing options been installed? (yes/no)

MEDIUM

38

Objective 3: Ensure effective communication of and within the network

Our approach

The network will develop its effectiveness in communication looking at both the internal and external communication of the HMA. It will explore how it can strengthen its communication of its objectives outside the network and how these support the wider objectives of the network. To deliver these wider objectives it will develop a clear communications strategy to provide a framework for the whole network. As part of the work to deliver this objective the network will focus on a number of initiatives supported by the Working Group on Communication Professionals (WGCP) to improve trust and build on the benefits that can be delivered in other action areas from this.

Contribution to the HLS

To contribute to this core requirement of effective communication for any efficiently operating network the HMA will strengthen its communications strategy to support its delivery of its key objectives. By strengthening its operation it can also achieve further improvements on health outcomes through better use of medicines and in the tackling of emerging health threats across the system.

Goal 3.1 – Strengthen public and political trust in the work of the authorities and the network


46. Incident Review Network effectiveness to be reviewed by EMA but an improvement to the system should be in place for emerging events with respect to non-authorised medicines (for example Ebola).

New working group on Availability

HMA Priority – Responding to public and animal health emergencies: System established in respect to non-authorised medicines? (yes/no)

MEDIUM

47. Increase transparency and proactivity in communicating the remit of HMA and NCAs in relation to our role in protecting public and animal health whilst ensuring a joined-up communications approach with EMA.

HMA MG HMA working group – communication professionals

HMA Priority - Optimisation of the regulatory operations: Clear strategy agreed and implemented for the network decisions made by NCAs? (yes/no) Is there evidence of closer links with EMA communications? (yes/no)

SHORT

39

Goal 3.2 - Ensure effective communication of and within the network (including strengthening links with EMA communications), strengthening the role of national communications teams and links between them (WGCP), joint campaigns e.g. internet sales.


48. Develop a strategic narrative for the work of HMA, its alignments with the objectives of the HLS and its practical implementation through the MAWP as part of a five year communication plan. Enhance regular communication from HMA to stakeholders, including exploring new ways to communicate as appropriate.

HMA working group – communication professionals

HMA Priority - Optimisation of the regulatory operations: Established and published communication narrative for the work of the HMA? (yes/no)

MEDIUM

49. Evaluate current mechanisms for sharing information between national communication teams and strengthen if necessary.


HMA Priority - Optimisation of the regulatory operations: Evaluation of information sharing conducted? (yes/no)

SHORT

50. Improved communication tools for patients and HCP’s to improve use of medicines including embracing new approaches to optimise communication in different media mediums, tailoring guidance on prescriptions and improving information to patients.


HMA Priority – Support for better use of medicines: Is there evidence of increased use and breadth of communication to patients? (yes/no)

MEDIUM

40

Objective 4: Strengthen the links with other authorities and with European stakeholders

Our approach

The HMA will implement a strategic approach to strengthen its collaboration with other authorities (both EU and globally) reflecting the impact other organisations within the regulatory environment can have on providing access to medicines. The network will explore how it can promote the networking and engagement with stakeholders to provide strategic outputs. In parallel to this goal the HMA network will optimise the mechanisms it has for responding to the needs and expectations of key stakeholders.

Contribution to the HLS

Strengthened external engagement will help to ensure that the network is able to fulfil its public health mission and work efficiently. Utilising opportunities for effective collaboration where it is to the advantage of the network and public health and by implementing more streamlined mechanisms to obtain regular feedback from key stakeholder will support the operation of the network as a whole.

Goal 4.1 – Strengthen links with other authorities and with stakeholders


51. Map key stakeholders at EU level. Agree key strategic areas of interactions. Plan for proactive engagement with such stakeholders. Agree plan of action with such stakeholders.

National competent authorities should strengthen national level links to agencies including pricing and reimbursement and health technology assessment and to patients and the public.


HMA Priority - Optimisation of the regulatory operations: Plan for proactive engagement and interaction with each identified stakeholder. (yes/no) Identification of key strategic aims for interaction. (yes/no) Plan to achieve aims. (yes/no)

MEDIUM/LONG

41

Goal 4.2 – Foster trust with other authorities and with stakeholders


52. Develop more streamlined mechanisms to obtain regular feedback from key stakeholders on the operation of HMA activities and the quality of the output.


HMA Priority - Optimisation of the regulatory operations: Defined mechanism for obtaining feedback and measurable improvement in the quality and effectiveness of feedback from stakeholders. (yes/no)

SHORT

42

Theme 4: Contributing to the global regulatory environment

Introduction

Contributing to the global regulatory environment is one of the main challenges as well as opportunities the network has faced in its long history of collaboration with countries inside and outside the EU, regarding human medicines and veterinary medicines. More recently the trend towards globalization of pharmaceutical activities and the complexity of global supply chains increased the demand for greater collaboration and regulatory convergence. Actively contributing to international collaboration initiatives and supporting the replication of the network model of collaboration in non-EU countries should be translated into concrete actions to effectively implement the HLS in this domain.


1. Assure product supply chain and data integrity

o Improving mechanisms for information sharing and oversight of activities of joint EU/non-EU activities 2. Convergence of global standards and contribution to international for a

o Contribution to international fora o Engagement with global standards

3. Ensure the best use of resources through promoting mutual reliance and worksharing o Increase cooperation for planning and optimal use of resources

4. Support training and capacity building and promote EU regulatory model o Share the EU capacity building concept globally

43

Objective 1: Assure product supply chain and data integrity

Our approach

The network is well aware of the significant challenges posed by the complexity and disruption of the global supply chain and of the need to ensure supply chain integrity, making sure all the steps are adequately controlled and monitored through appropriate oversight of all activities. In a globalized scenario working towards common standards and mutual reliance are key to achieve sustainable results for EU and non EU regulators.

Contribution to HLS

Sharing information between regulators internationally through appropriate channels and mechanisms is key to ensuring that the oversight of activities is achieved. Establishing mutual trust and using work-sharing mechanisms are also indispensable to understand the drivers behind practices with a view to promoting a culture of compliance. Making available an accurate overview of existing supply channels can be a facilitating feature to achieve this objective.

Goal 1.1 - Improving mechanisms for information sharing and oversight of joint EU/non -EU activities


53. Mapping of the existing supply and distribution channels within the network (pharmacies, outlets, internet sales and wholesale distributors) to obtain an overview of the different systems in EU member states to support enforcement of the falsified medicines legislation and adequate response in crisis situations (i.e. volcano operation).

HMA WGEO EMA (inspectors group)

HMA Priority – Strengthen surveillance:

How many descriptions of supply systems have been shared? (figure)

SHORT

44

54. Support and encourage the use of work-sharing mechanisms for ensuring the quality and safety of APIs such as WHO Prequalification of APIs and International API inspection program Certificates of Suitability of the European Pharmacopoeia (CEP). Establish and reinforce cooperation with Codex Alimentarius Committees and with OIE programs.

Create a Joint EDQM EMA HMA task force

HMA Priority – Strengthen surveillance:

Has a list of work-sharing initiatives been completed? (yes/no)

Have the deliverables of work-sharing initiatives been identified? (yes/no)

SHORT

45

Objective 2: Convergence of global standards and contribution to international fora

Our approach

The network will take a lead role in convergence of global standards assuring appropriate representation in international fora and will put in place mechanisms to strengthen cooperation with non-EU regulators in a consistent and integrated manner. Such activities are key to facilitating timely access to safe and effective medicines for patients worldwide.

Contribution to HLS

The HMA will endeavor to strengthen and promote cooperative mechanisms between international regulators, ensuring that the organisation of and participation in international fora is representative and that feedback is provided to the network and, as appropriate, to stakeholders. Through active cooperation with international regulators the network will strive to explore the deployment of initiatives towards the convergence of global standards.

Goal 2.1 - Contribution to international fora


55. Explore mechanisms to effectively disseminate information and input to the network on the outcomes of international fora, as a regular agenda point in the HMA meetings to coordinate HMA views and an integrated representation in international fora.

Representatives on international meetings feeding back via HMA MG

HMA Priority – International collaboration: In HMA meetings, list and share topics and the common position of the network. (yes/no)

SHORT

56. Ensure adequate involvement and coordinated positions of NCAs at EU regulatory level in order to be informed and to provide input on the basis of the expertise of the NCA when Commission or EMA have the mandate on behalf of the EU.

Representatives working with HMA MG

HMA Priority – International collaboration: Listed and shared NCA involvement and outcomes in EU regulatory initiatives at HMA meetings or in writing between meetings? (yes/no) Discussed and agreed common positions to feed in at EU level? (yes/no)

SHORT

46

57. Foster, as appropriate, coordinated involvement in networks outside EU, to promote greater links with international regulators.

Representatives working with HMA MG

HMA Priority- International collaboration:

Mapped and made available to HMA the formal and informal representation with level of responsibility if applicable from EC/HMA/EMA and NCA individually? (yes/no)

SHORT

Goal 2.2 - Engagement with global standards


58. Develop jointly with EMA an information toolkit about the EU regulatory framework for external audiences, to clarify the roles of members and partners, enhance knowledge to avoid misinterpretations and misconceptions about the framework, towards compliance and trust within a global context.

WG of Communication Professionals EMA

HMA Priority – International collaboration:

Has an information toolkit about the EU regulatory system been created? (yes/no)

SHORT

59. Promote convergence and harmonization of regulatory processes with non EU bodies in areas of common interest, as collaboration with OIE, ICH, VICH, GxP, PICS and ICMRA.

HMA MG (in coordination with working groups)

HMA Priority – International collaboration: Number of deployed initiatives on convergence of regulatory processes. (figure)

LONG

47

Objective 3: Ensure best use of resources by promoting mutual reliance and worksharing

Our approach

The network will promote best use of collective global resources by promoting mutual reliance as a consequence of improved information exchange, convergence of standards and work-sharing with non EU regulatory partners and sharing of information about European regulatory approaches.

Contribution to HLS

The network will foster the promotion of collaborative approaches and initiatives towards optimal use of resources and effective planning. It will ensure continued participation in international initiatives and programmes and provide information and training.

Goal 3.1 - Increase cooperation for planning and optimal use of resources


60. Develop coordinated initiatives to allocate sufficient resources to GxP inspections, namely through:

GMPs multinational teams including non EU regulatory authorities to avoid duplication of work and sharing of best practices

training of new GxP inspectors to increase participation in GCP/GMP international inspections and continued participation in multinational inspection teams, PIC/S, including non-EU countries members without MRA.

GMP/GDP Inspectors Group in coordination with EU-NTC

HMA priority – Developing an efficient, effective and collaborative approach on inspections to address sustainability: Number of training activities. (figure) Number of times a GMP inspection has not been needed to be conducted due to reliance on other MS. (figure) Has a list of EU and non EU contact points been created to inform national inspectorates of any international inspection due to take place in their territory, with the aim of allowing national inspectors to observe the inspection, thus serving the ultimate goal of creating mutual trust and recognition between inspectorates? (yes/no)

MEDIUM

48

61. Promote cooperation and information exchange in the field of worldwide medicines assessment, regulation, and new and post marketing authorisation.

CMDx HMA Priority - International collaboration: Number of IGDRP reports to HMA. (figure) Has the tools for increased exchange of information with other authorities been listed? (yes/no) Is the evidence that there has been more effective use of the established channels for exchange of information? (yes/no) HMA MG action: Has information on existing bilateral MOUs and planned activities, in order to promote synergies in this domain been made available, in a restricted area of the HMA website? (yes/no)

SHORT

49

Objective 4: Support training and capacity building and promote the EU regulatory model

Our approach

The network will build on existing approaches to training and capacity building for non-EU regulators in order to promote international best practices, improve capacity and facilitate mutual reliance.

Contribution to HLS

Non EU regulators are increasingly looking to the network for support and capacity building and as a model for their regional harmonization initiatives. The network should meet this increasing demand for capacity building through existing mechanisms that can deliver a coordinated response across the network, in a synergistic manner and using the existing collective resources.

Goal 4.1 - Share the EU capacity building concept globally


62. Support the further development and strengthening of the EU Network Training Centre (EU-NTC) including promoting access to outcomes of European projects (for example SCOPE training actions) and the training catalogue.

EU NTC HMA Priority – Competence development programme through the EU Network Training Centre: Number of non-EU agencies receiving information on EU training and exchange programmes. (figure) List of projects with member State involvement produced and regular information on deliverables disseminated on the HMA website? (yes/no)

MEDIUM

63. Explore how we can enhance and better coordinate our outreach capacity building.

EU NTC HMA Priority – Competence development programme through the EU Network Training Centre: Number of non-EU agencies participating in EU training and exchange programmes and on the job training. (figure) Has a plan been developed on outreach capacity building? (yes/no)

MEDIUM

50

Glossary

AMR Antimicrobial resistance

API Active Pharmaceutical Ingredient

BEMA Benchmarking of European Medicines Agencies Steering Group

CEP Certificate of Suitability

CESP Common European Submission Portal

CHMP Committee for Medicinal Products for Human Use

CMDh Co-ordination group for Mutual recognition and Decentralised procedures – human

CMDv Co-ordination group for Mutual recognition and Decentralised procedures – veterinary

COMP Committee for Orphan Medicinal Products

CVMP Committee for Medicinal Products for Veterinary Use

EEA European Economic Area

EMA European Medicines Agency

EU European Union

FMD Falsified Medicines Directive

GCP Good Clinical Practices

GMP Good Manufacturing Practice

GXP Good (related subject) Practice

HLS High Level Strategy (EU Medicines Agencies Network Strategy to 2020)

HMA Heads of Medicines Agencies

HTA Health Technology Assessment

ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

ICMRA International Coalition of Medicines Regulatory Authorities

IGDRP International Generic Drug Regulators Programme

51

IMI Innovative Medicines Initiative

IPRF International Pharmaceutical Regulators Forum

IRCH International Regulatory Cooperation on Herbal Medicines

JAP Joint Audit Programme

MRP Mutual Recognition Procedure

MUMS Minor Use Minor Species

NCA National Competent Authority

PIC/S Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme

PRAC Pharmacovigilance Risk Assessment Committee

SME Small and medium-sized enterprises

STAMP Safe and Timely Access to Medicines for Patients

VHP Voluntary harmonisation procedure

VMPs Veterinary medicinal products

WHO World Health Organization

EU Medicines Agencies Network Strategy to 2020...The lack of availability of medicines is considered...

Documents

Transcript of EU Medicines Agencies Network Strategy to 2020...The lack of availability of medicines is considered...