East African Community

Medicines Registration Harmonization Project

Prepared by:Margareth Ndomondo-SigondaAfrican Union NEPAD Agency13th February 2013

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Presentation Outline

1. Brief background of the AMRH initiative

2. Progress on EAC Medicines Registration Harmonization Project

3. Continental progress

4. Conclusion

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1.Background

Est.: OAU – May 1963 AU – July 2002Tel: +251-11 551 77 00 Fax: +251-11 551 78 44 Website: www.africa-union.org

Head Office Address: P.O. Box 3243, Roosevelt Street (Old Airport Area), W21K19, Addis Ababa, Ethiopia

Algeria

Angola

Benin

Botswana

Burkina Faso

Burundi

Cameroon

Cape Verde

C/African Rep.

Chad

Comoros

DRC

Congo

Côte d’Ivoire

Djibouti

Egypt

Equatorial Guinea

Eritrea

Ethiopia

Gabon

Gambia

Ghana

Guinea

Guinea-Bissau

Kenya

Lesotho

Liberia

Libya

Madagascar

Malawi

Mali

Mauritania

Mauritius

Mozambique

Namibia

Niger

Nigeria

Rwanda

Sharawi Arab DR

São Tomé & Prínc.

Senegal

Seychelles

Sierra Leone

Somalia

South Africa

Sudan

Swaziland

Tanzania

Togo

Tunisia

Uganda

Zambia

Zimbabwe

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African Union

• 54 member states of the African Union– fifty two republics, and two kingdoms– South Sudan is the newest member state, joining on 2011

July 27

• Total population: 895,800,000• 8 Regional Economic Communities:

– Arab Maghreb Union (UMA), Common Market for Eastern and Southern Africa (COMESA), Community of Sahel Saharan States (CEN-SAD), East African Community (EAC), Economic Community of Central African States (ECCAS), Economic Community of West African States (ECOWAS), Intergovernmental Authority on Development (IGAD) and Southern Africa development Community (SADC)

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New Partnership for Africa’s Development (NEPAD)

•2001: A Programme of the African Union (AU) adopted in Lusaka, Zambia•February 2010: Integration of NEPAD under the AU structures

• Re-newed mandate as a technical body of the African Union to:• Facilitate and coordinate the implementation of the

continental and regional programmes and projects;• Mobilize resources and partners in support of the

implementation of Africa’s priority programmes and projects;• Conduct and coordinate research and knowledge

management;• Coordinate the implementation of programmes and

projects, &• Advocate on the AU and NEPAD vision, mission and core

principles/values

PMPA-AMRH Genesis

African Union Assembly Decision 55 of 2005 - Abuja Summit:African Union Commission (AUC) to develop a Pharmaceutical Manufacturing Plan for Africa (PMPA) within the NEPAD FrameworkAim: to contribute to a sustainable supply of quality essential medicines to improve public health and promote industrial and economic development on the continentAMRH critical for successful implementation of PMPA :

Legislative framework: Sound regulatory systems e.g. GMP, GDP, GCP e.t.c. Full use of TRIPS and related flexibilities Appraisal of technical feasibility and financial viability A market size to ensure sustainability Technology transfer Human resource Duties and taxes

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2. AMRH Vision, Mission & Strategic Directions

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AMRH VISION & MISSION

VISION:African people have access to essential medical products and technologies

MISSION:Provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa

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AMRH Strategic Directions• Policy and Regulatory Reforms

– Increased use of harmonized policies and regulatory frameworks by member states

• Regulatory capacity Development – Increased human and institutional capacity for regulation of medical

products and technologies

• Knowledge Management– Knowledge assets on medicines regulation at country, regional and

continental levels created• Community of Practice• 1st Biennial Scientific Conference

• Enabling environment for AMRH– Partnership Platform Accountability Framework– M&E and impact assessment tool implemented04/19/23 10

Consortium of key partners established to accelerate and ensure African Medicines Regulatory Harmonization

(AMRH)

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Consortium and majorstakeholders convened inFebruary and November

2009

Consortium Partners

Other Stakeholders NMRA Representatives

Regional Economic Communities and Organizations (RECs)

COHRED

• Unanimous consensus emerged: now is the right time to push for regulatory harmonization in Africa

• Global Medicines Regulatory Harmonization - Multi-Donor Trust Fund established under the World Bank

AMRH…• Approach:

– Building on the existing regional efforts, political mandates and plan

– Registration as pathfinder to a broader harmonization of other regulatory functions and products

• Overall aim:Improve public health by increasing access to safe and

effective medicines of good quality for the treatment of priority diseases

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AMRH …

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Earlier approvalof more

medicines & vaccines

Today

~ 54 National Medicines Regulatory Authorities (NMRAs) governing medicines regulation across Africa

Lack/inadequate medicines policies and laws

Regulators' capacity highly variable: Financial, HR, Institutional

Different requirements and formats, lack of clear guidelines

Minimal transparency, No clear timelines

Reference evaluations1 underleveraged

Streamlined (harmonized)

future

Between 5-7 regional economic communities (RECs)

covering the entire African continent1

Harmonized medicines policies and Laws

Stronger, institutionalized regulatory capacity & systems

strengthening programmes

Single set of requirements, Clear guidelines, Fewer

dossiers to prepare

Transparent regulatory processes with clear timelines

Resource pooling and information sharing1. WHO prequalification, Article 58 positive opinions, stringent regulatory approval, certificate of pharmaceutical product (CPP) 13

Critical Milestones

Member States Operating independently

Member States Collaborate on selected topics

Harmonised standards and broad collaboration

Centralized Procedure

• each country has its own technical requirements and format for registration applications

Regional harmonised guidelines & procedures: •Guidelines for registration of medicines•Procedures for evaluation of medicines•GMP guidelines & Inspection procedures

• Joint evaluations and inspections

• Sharing assessment and inspection reports

• Quality Management Systems

• Information Management Systems

Centralized registration on behalf of participating member states

Regional Medicines Agencies e.g. EAC-MFSA

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1. Harmonised requirements and standards

Not Harmonised Fully Harmonised

National sovereignty is respected: Medicines registration decisions remaining firmly that of sovereign nations

Robust & transparent regulatory processes

Critical Milestones

Working independently

Member States Collaborate on training programmes

Harmonised training standards and broad collaboration

Utilise Existing Regional structures & expertise: NMRAs & Academic institutions

Existing training programmes for NMRA staff based on donor funding

• Evaluation & registration of medicines

• GMP Inspections

• Quality Management Systems

• Management Information Systems

• Harmonised training curriculum

• Certification • Evaluation of

training programmes

• Potential partners: WHO, US-FDA, PQM, AfDB, EDCTP, ANDi, PDPs, SIAPS

Short Term:•Twinning/Exchange programmes among NMRAs within & outside the continent•Regional Centres of Regulatory Excellence (RCORE)Long-Term:•Engagement of academic institutions to offer post graduate courses in Regulatory Science

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2. Regulatory capacity building & systems strengthening

Ad-hoc training programmes Institutionalised training programmes

• Increased regulatory workforce in Africa

Critical Milestones

Current status Country level Regional level Continental level

• Lack/Weak medicines laws

• Medicines regulated within territories

• Varying comprehensiveness of laws

• No sanctions on non compliance to regional treaties

• Adoption and domestication of model law on medicines regulation

• Mutual recognition agreements

• Binding regional legal instruments

• At least 5 regions have adopted regionally harmonized policies and legislative frameworks

• At least 20 countries implementing the regionally harmonized policies and legislative frameworks

• At least 2 regional medicines agencies established

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3. Policy and Regulatory Reforms

Inadequate policies & laws Harmonised policies & Laws

• Increased adoption of regionally agreed standards• Mutual recognition of regulatory decisions

• Establishment of regional medicines agencies

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East African Community (EAC) Project on Medicines Registration Harmonization

LOCATION MAP OF EAST AFRICA

N

EAC… • A regional grouping of 5 countries: Burundi, Kenya, Rwanda,

Tanzania, Uganda• Population:133.1 million• GDP: USD 79.2 billion• GDP per capita ($685) as of 2011• Public health challenges:

– Preventable communicable diseases responsible for the highest morbidity and mortality– Limited access to essential medicines for the treatment of preventable diseases

• High prices, different drug registration requirements, Reliance on importation• Varied capacity of the six (6) EAC NMRAs

• Chapter 21 (Article 118) of the EAC treaty concerning health issues in the Partner States priorities on health– Provides for regional cooperation among EAC Partner states on health, trade e,t,c– Harmonization of national health policies and regulations and promote the exchange of

information on health issues– Harmonization of drug policies, registration and regulation

EAC Key Decisions… 2• Directive of the EAC Council of Ministers of 2000:

– Research, Policy and Health Systems Working group to draft common Drug Policy and Harmonized drug regulation procedures

– Meeting of Technical staff from NMRAs in EAC, Dar es Salaam 2001

• Guidelines and application forms for registration of Veterinary Drugs

• EAC Customs Union, January 2005– Common External Tariffs on raw materials and products

• African Drug Regulators Conference, Addis Ababa 2005 recommendations– Promote harmonization using existing RECs, e.g, EAC, SADC,

ECOWAS/WAHO, ECSA, etc

• Various NMRA meetings held between 2005-2009

EAC MRH Process• May 2009: Submission of MRH project proposal to AMRH

Consortium• May - September 2009

– Approval of preparation of the EAC-MRH expended project by the 18th EAC Council of Ministers

– Expanded EAC DRH Project Proposal EAC/NEPAD/WHO Meeting

• May 2010 Zanzibar & Arusha, Tanzania– regional workshop to provide feedback & comments from AMRHI Consortium

of Partners into the Expanded EAC MRH Project Proposal organised by EAC-WHO-NEPAD

– EAC Secretariat and EAC NMRAs and the pharmaceutical industry, AU/NEPAD Agency and WHO incorporated comments and repackaged EAC MRH proposal

• Sept - Nov 2010; Arusha, Tanzania and Nairobi, Kenya– EAC NMRAs, EAC Secretariat, AU/NEPAD, WHO, the World Bank , GIZ

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EAC MRH Process…

• World Bank establishment of the Global Medicines Regulatory Harmonization Multi-Donor Trust Fund– Bill and Melinda Gates commitment US$ 12.5mill as start-up fund– May 2011: Fiduciary & Procurement Assessment of EAC conducted by

World Bank

– 10th - 22nd October 2011: Project Appraisal Missions in EAC Partner States conducted

– 27th January 2012: Joint EAC/World Bank Negotiations of the Financial Grant Agreement conducted on Friday

• 30th March 2012– EAC MRH Project Launch, Arusha, Tanzania

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EAC-MRH Project Governance

Project Steering Committee supported by technical Working Groups•Provide oversight on MRH Project implementation

•Composed of EAC Heads of NMRAs, Chief Pharmacists from Ministries of Health, members of four project Technical Working Groups & AMRH Partners (as observers)

•2 meetings held in June 2012 & November 2012 in Bujumbura, Burundi and Arusha, Tanzania, respectively

•Objectives:– receive progress reports from the EAC Partners States NMRAs and EAC Secretariat on the

implementation of MRH Project activities; – Receive progress on the four Technical Working Groups (TWGs);– Review and approve annual work plans and budgets04/19/23 23

Technical Working Group on Medicines Evaluations & Registration

• Tanzania Food and Drugs Authority (TFDA) – Lead; supported by Burundi Department of Pharmaceuticals and Medical Laboratories (DPML)

• Key Milestones:– Draft EAC guidelines on format and content of labels for medicinal

products– Draft EAC guidelines on the format and content of patient information

leaflet (PIL) for Medicinal Products– Draft EAC guidelines on the format and content of summary of product

characteristics for medicinal products (SmPC)– Draft EAC Guidelines on Stability requirements– Final draft of the EAC Application Form for registration of human

medicines– Stakeholders consultation on draft guidelines planned for March 2013

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The Technical Working Group on Good Manufacturing Practises (GMP)

• Uganda National Drug Authority (NDA) – Lead; supported by Rwanda Pharmacy Task Force (PTF)

• Key Milestones:– Preparation of Terms of Reference for the TWG– Finalization of EAC GMP Inspection Manual,– EAC Standard Operating procedures (SOP) for conducting

GMP inspection, – EAC GMP Report Writing Format,– EAC GMP Format for Executive Summary

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Technical Working Group on Information Management Systems (IMS)

• Rwanda Pharmacy Taskforce (PTF) – Lead; supported by Pharmacy and Poisons Board (PBB), Kenya

• Key Milestones:– Completion of Terms of Reference for the consultancy to

conduct an assessment of the current state of the existing IMS aimed to:

• design and develop technical specifications for a harmonized IMS in the EAC Partner States, NMRAs and the EAC Secretariat

– Revised ToRs for the TWG– Completed draft guidelines for the development of the

common IMS

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Technical Working Group on Quality Management Systems (QMS)

• Pharmacy and Poisons Board (PBB) of Kenya – Lead; supported by Zanzibar Food and Drugs Board (ZFDB)

• Key Milestones:– Finalised ToRs for QMS TWG– Completed draft documents on:

• EAC Quality Management Requirements• Guidelines for implementation of EAC QMS requirements• EAC QMS Manual

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Continental Progress• AMRH Advisory Committee established

– NEPAD Agency Secretariat– Coordination and Political advocacy

• Technical Working Groups– Regulatory Capacity Development– Medicines Policies & Regulatory Reforms

• July 2012: 19th AU Assembly decision on Roadmap for Shared Responsibility and Global solidarity for the AIDS, TB and malaria response in Africa – emphasises on the need to accelerate and strengthen regional

medicines regulatory harmonization initiatives– lay foundations for a single African regulatory agency

• Draft Model law for Medicines Regulation Harmonization in Africa developed– Stakeholders consultations planned for 2013

Conclusion• AMRH is a strategic initiative for pharmaceutical sector

development in Africa

• Strong political constituency and partnerships built– NMRAs, pharmaceutical industry & Civil Society, RECs and AU

organs (AUC, NEPAD Agency, PAP)

• Strong partnerships built with donors & international institutions– WHO, World Bank, UNAIDS, AFDB, DFID, Bill and Melinda Gates

Foundation• Cooperation, collaboration and commitment by all

stakeholders is key for success

• EAC MRH Project provides a Model for replication to other RECs

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Thank you for your attention!

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