ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION

TOPRA Veterinary Medicines Symposium 2017

eSubmission roadmap v2.0: Industry viewpoint Patrizia Oelker – Boehringer Ingelheim Animal Health

To review the vet-relevant components of the eSubmission Roadmap v2.0

To identify progress made towards reduction of administrative burden

To identify further opportunities

To raise awareness of practical implications for industry of on-going IT development

Relevant eSubmission Roadmap components: 1. VNeeS

2. Common repository 3. Integrated submission portal

4. CESSP 5. SPOR

Presentation objectives

New milestones for VNeeS mandatory use in national procedures (NP)

Q3 2018 for new MAA Q1 2019 for all submissions

This is in agreement with IFAH-Europe’s position to allow

sufficient time for smaller veterinary companies to accommodate to the new requirements

1. VNeeS

2. Common Repository

Applicants/MAHs submit applications only once to EMA (via current Gateway/Web Client) No further submissions by other means to any MS Single & centralised archiving of submission packages for the NCA Network with remote access to dossiers - all submission types

2. Common Repository

One integrated portal with one single user registration for all procedure types

Mandatory use in Q3 2019

Further reduction of administrative burden

Strong plea that all NCAs accept

CESP-only submissions well before Q3 2019

3. Integrated submission portal

Preparing an MRP or DCP submission today

Member State 1 2 3 4 5 6 7 8 9 … n

CESP can be used ? x x x x x x x x CESP + signed paper copy of eAF ?

x x

CESP + signed paper copy of CL ?

x

eAF may bear text snippet

x x x x

eAF must bear scanned signature

x x x x x x

Some documents in national language ?

x

Payment in advance? x x x Bank account provisioning?

x x

Other national req.? x

CESSP: Common European Single Submission Portal

Web user interface

Application ‘datasets’ generated online will replace eAF

For new MAA and line extensions: 2018

For variations and renewals in a 2nd step

1st UAT in May 2017

4. CESSP data sets

Need to convert CESSP output into a human readable file format, also archivable long-term

Confirmation sought that VNeeS packages with CESSP output will be accepted by all NCAs for all procedures

− Having to manage different systems/processes increases complexity and in consequence administrative burden

To what extent is IDMP compatibility of CESSP desirable for the veterinary sector ?

4. CESSP – some technicalities

What impact for companies ?

5. Integration with SPOR

Will be integrated with eAF and CESSP

After a transition period, current free text fields for MA applicant / MA Holder / manufacturers will be replaced by drop down lists.

Pre-registration of Org. details in OMS by Industry ahead of submission will be needed

Change will be validated by EMA team

Check OMS before starting eAF compilation !

Factor more time in case a change request to EMA must be filed

Refer to EMA document on SPOR SLAs

5.1 OMS impact

Already integrated with eAF

Will be integrated with CESSP

Similar to current process:

− Industry to request registration of new/updated terms before regulatory submission

− Change will be validated by EMA team

Check RMS before starting eAF compilation

Factor more time in case a change request to EMA must be filed

Refer to EMA document on SPOR SLAs

Refer to EMA explanatory document linked to each referentials list

5.2 RMS impact

Management Systems for Substances and Products

Integration of SMS with eAF and CESSP will require pre-registration of substances in SMS

IFAH-Europe’s vision: single data entry in CESSP (i.e. PMS consumes product data from CESSP)

However, discussions at the EMA working groups are largely dominated by Human Pharma concerns and needs (legal obligation in the EU to comply with ISO IDMP requirements)

5.3 SMS & PMS

IFAH-Europe calls for simple and cost effective IT solutions for the veterinary domain

to reduce administrative burdens

ISO IDMP is not a requirement for the veterinary sector

SMS & PMS implementation must be:

− appropriately adapted to AH considering size and requirements

− only to the extent necessary

− thereby contributing to the goal of the EU Commission proposal for a Regulation on VMPs*

*2014/0257 (COD)

5.3 SMS & PMS

Concluding remarks

100%

3%

6%

13%

IFAH-Europe calls for: − simple and cost-effective IT

solutions, − harmonisation of tools amongst

various procedures (CP, MRP/DCP, NP).

Goal of the EC proposal: − reduce administrative burdens, >> increasing the availability of

VMPs and stimulating competitiveness.

*Assessment of the Impact of the Revision of Veterinary

Pharmaceutical Legislation , 11 July 2011

EU eSubmission Roadmap v2.0

Thank you for your attention

• CESP: Common European Submission Platform

• CESSP: Common European Single Submission Platform

• CL: Cover Letter

• eAF: electronic Application Form

• IDMP: IDentification of Medicinal Products

• IFAH-Europe: International Federation for Animal Health-Europe

• OMS: Organisations Management System

• MAA: Marketing Authorisation Application

• NCA: National Competent Authority

• PMS: Products Management System

• RMS: Referentials Management System

• SLA: Service Level Agreement

• SMS: Substances Management System

• SPOR: Substances, Products, Organisations, Referentials

• UAT: User Acceptance Testing

• VNeeS: Veterinary Non-eCTD electronic Submission

Acronyms

Link to the EMA eSubmission website

http://esubmission.ema.europa.eu/tiges/vetesub.htm

Link to the eSubmission Roadmap v2.0

http://esubmission.ema.europa.eu/tiges/cmbdocumentation.html

Back up slides

eSubmission Roadmap v1.0 (reflecting final adopted version 1.0 dated 141107)

2013 2014 2015 2016 2017 2018

Use of eAF in all procedures (human and vet)

Single Submission Portal with integration of eAF

for all submissions (human and vet)

Use of VNeeS in CP, DCP and MRP (vet)

All submissions in CP, DCP and MRP (human) in

eCTD

Ongoing/optional Mandatory

Use of eCTD v.4

CESP (human and vet)

eGateway (CP) (human and vet)

eGateway (CP, human)

NCA use of Common Repository for all CP submissions (human)

All submissions in CP, DCP and MRP (vet) in VNeeS

NCA use of Common Repository for CP submissions (human)

Single submission portal - combined CESP/Gateway in all other procedures (human and vet)

Use of NeeS and eCTD in DCP and MRP (human)

in CP

New MAA in DCP (human) in eCTD

All submissions in MRP (human)

New MAA in DCP and MRP (human) in eCTD

All other in CP and all MRP submissions (vet)

New MAA in CP and DCP (vet) in VNeeS

All other MRP submissions (human)

eAF in all procedures (human and vet)

All submissions in CP (human) in eCTD

Use of PSUR Repository for all CAPs and NAPs (human)

Use of PSUR Repository for CAPs and NAPs (human)

draft eSub

Roadmap

NCA & industry survey

eSub Roadmap Adoption

Single submission portal - combined CESP/Gateway in CP (human)

in all other procedures

22

eSubmission Roadmap v1.0 (reflecting final adopted version 1.0 dated 141107)

2013 2014 2015 2016 2017 2018

Use of eAF in all procedures (human and vet)

Single Submission Portal with integration of eAF

for all submissions (human and vet)

Use of VNeeS in CP, DCP and MRP (vet)

All submissions in CP, DCP and MRP (human) in

eCTD

Ongoing/optional Mandatory

Use of eCTD v.4

CESP (human and vet)

eGateway (CP) (human and vet)

eGateway (CP, human)

NCA use of Common Repository for all CP submissions (human)

All submissions in CP, DCP and MRP (vet) in VNeeS

NCA use of Common Repository for CP submissions (human)

Single submission portal - combined CESP/Gateway in all other procedures (human and vet)

Use of NeeS and eCTD in DCP and MRP (human)

in CP

New MAA in DCP (human) in eCTD

All submissions in MRP (human)

New MAA in DCP and MRP (human) in eCTD

All other in CP and all MRP submissions (vet)

New MAA in CP and DCP (vet) in VNeeS

All other MRP submissions (human)

eAF in all procedures (human and vet)

All submissions in CP (human) in eCTD

Use of PSUR Repository for all CAPs and NAPs (human)

Use of PSUR Repository for CAPs and NAPs (human)

draft eSub

Roadmap

NCA & industry survey

eSub Roadmap Adoption

Single submission portal - combined CESP/Gateway in CP (human)

in all other procedures

IDMP (IDentification of Medicinal Products) SPOR is used to implement ISO IDMP in the EU

The ISO IDMP standards were developed in response to a worldwide demand for internationally harmonized specifications for medicinal

products (authorized and investigational)

In the EU, for Human Pharma: ISO IDMP is a legal requirement

– Pharmacovigilance Legislation, in particular EC Regulation 1235/2010, and

– Commission Implementing Regulation 520/2012 (= the “IDMP Regulation”)

ISO Standards should be implemented in other regions/ countries too (US, Canada, Switzerland,…)

Key Goals: - standardise the information, - have interoperable systems, - enhance patient safety (PhV!)