THE AFRICAN MEDICINES THE AFRICAN MEDICINES THE AFRICAN MEDICINES THE AFRICAN MEDICINES REGULATORY HARMONIZATION REGULATORY HARMONIZATION REGULATORY HARMONIZATION REGULATORY HARMONIZATION

(AMRH) INITIATIVE(AMRH) INITIATIVE(AMRH) INITIATIVE(AMRH) INITIATIVEAccomplishments, Challenges and Accomplishments, Challenges and Accomplishments, Challenges and Accomplishments, Challenges and

Path ForwardPath ForwardPath ForwardPath Forward

THE AFRICAN MEDICINES REGULATORY HARMONIZATION (AMRH) INITIATIVE

Accomplishments, Challenges and Path Forward

Cape Town

Pre-ICDRA

27 November 2016

Objective Objective Objective Objective • To provide To provide To provide To provide background and overview background and overview background and overview background and overview of the AMRH of the AMRH of the AMRH of the AMRH InitiativeInitiativeInitiativeInitiative

• AccomplishmentsAccomplishmentsAccomplishmentsAccomplishments

• Challenges and Challenges and Challenges and Challenges and

• Path ForwardPath ForwardPath ForwardPath Forward

2005: AU Decision55 on Development of the Pharmaceutical Manufacturing Plan for 2005: AU Decision55 on Development of the Pharmaceutical Manufacturing Plan for 2005: AU Decision55 on Development of the Pharmaceutical Manufacturing Plan for 2005: AU Decision55 on Development of the Pharmaceutical Manufacturing Plan for Africa (PMPA) within the NEPAD FrameworkAfrica (PMPA) within the NEPAD FrameworkAfrica (PMPA) within the NEPAD FrameworkAfrica (PMPA) within the NEPAD Framework

2007: AU Ministers Decision on PMPA

2012: PMPA Business Plan &

AU-Roadmap on Shared Responsibility & Global Solidarity for ATM response in Africa

2015: AU Executive Council Decision on AMRH as foundation for African Medicines Agency (AMA)

Creating an Enabling Regulatory Environment---AMRH

Pharmaceutical sector development (Optimizing the African Market for new medical products and technologies)

Increased access to medical products and technologies

Background

AMRH OVERVIEW

5

Init

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Init

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Regional regulatory platforms

� Harmonized standards (technical requirements /

guidelines)

� Joint and regional dossier assessments /

GMP inspections

� Work sharing / pooling of resources

� Streamlined decision-making processes

Reduced registration cycle time...

� ...starting with generics

� ...extending to other product categories

(NCEs, vaccines, diagnostics)

� Extending to other regulatory functions over

time (clinical trials, safety surveillance, etc.)

� Extending to other African regional blocs

� Is a partnership initiative formalized in 2009 and launched in the East African Community

countries in 2012 (Tanzania, Uganda, Kenya, Burundi, Rwanda)

� Partnership includes African countries (regulatory authorities) and regional economic

communities, WHO, PAP, AUC, NEPAD, Gates Foundation, DFID, PEPFAR/USG, GAVI,

World Bank

� Aims to improve the fragmented regulatory system for product registration in Africa by

changing from a country-focused approach to a collaborative regional and simplified

approach

� Stepwise approach - start by harmonizing and streamlining technical requirements for product registration, leading to increased and timely product access

� Creates a platform to build African regulatory capacity by region

IGAD / AMU /

CEN-SAD

ECCAS

OCEAC

ECOWAS

UEMOA EAC

SADC

COMESA

Accomplishments

11/29/2016 7

Completed or in-process RECs

Countries

covered

Total

members*

% pop

covered

EAC & OCEAC

EAC, OCEAC, ECOWAS

EAC, OCEAC, ECOWAS, SADC

12 (20%)

26 (46%)

41 (74%)

11

26

41

17%

45%

72%

REC progress

SADC

We are pushing forward those RECs that are ready while

continuing to work with the remaining regions

•REC• EAC

• CEMAC-OCEAC

• WAHO/UEMOA

• SADC

• North/North-

Eastern

Africa

•Status •Comments•Implementation

•In progress

•Implementation

•Implementation

•Preparatory Stage

•Launched March 2012

•Launch Nov. 2016

•Launched Feb 2015

•Launched July 2015

7

EAC

ECCAS/OCEAC

CEN-SAD/UMA/COMESA

IGAD

Roughly 85% of SubRoughly 85% of SubRoughly 85% of SubRoughly 85% of Sub----Saharan Africa covered with medicines registration Saharan Africa covered with medicines registration Saharan Africa covered with medicines registration Saharan Africa covered with medicines registration harmonization (MRH) Projects at different levels harmonization (MRH) Projects at different levels harmonization (MRH) Projects at different levels harmonization (MRH) Projects at different levels

8

East African Community (EAC)… “The Model”East African Community (EAC)… “The Model”East African Community (EAC)… “The Model”East African Community (EAC)… “The Model”

Progress attainedProgress attainedProgress attainedProgress attained Systemically expanding to other regulatory functions and products

• Pharmacovigilance (PV)

• Medical devices & diagnostics,

• Clinical Trials Oversight

• Vaccine registration harmonization

Lead country approach:

• Tanzania (TFDA) - product evaluation & registration

• Uganda NDA - GMP inspections

• Kenya PPB - QMS & PV

• Rwanda - IMS

Joint assessments and inspections

� 27 applications assessed jointly, 4 products registered

� reduced registration time to <6months

� Streamlined GMP inspections

RegionRegionRegionRegion

� EAC MRH Launch in March 2012

� Harmonized standards (technical guidelines and requirements) approved by Council of Ministers

� Registration of medicines

� Good Manufacturing Practices

(GMP)

� Quality Management System (QMS)

� Information Management System

(IMS)

� Came into force from Jan. 2015, countries at different levels of implementation

� Twinning programme

� Burundi - Tanzania (Mainland)

� Rwanda – Uganda

� Zanzibar – Kenya (&TFDA)

9

West AfricaWest AfricaWest AfricaWest Africa

� ECOWAS and WAEMU launched ECOWAS and WAEMU launched ECOWAS and WAEMU launched ECOWAS and WAEMU launched a a a a

Medicines Regulatory Medicines Regulatory Medicines Regulatory Medicines Regulatory

Harmonization (MRH) Project Harmonization (MRH) Project Harmonization (MRH) Project Harmonization (MRH) Project in in in in

February 2015February 2015February 2015February 2015

� 1111stststst Meeting of Joint MRH Project Meeting of Joint MRH Project Meeting of Joint MRH Project Meeting of Joint MRH Project

Steering Committee, Steering Committee, Steering Committee, Steering Committee, February 2015

• 2nd Steering Committee meeting,

20 April, 2016

• Alignment of WAHO and WAEMU Alignment of WAHO and WAEMU Alignment of WAHO and WAEMU Alignment of WAHO and WAEMU

Common Technical Document (CTD)Common Technical Document (CTD)Common Technical Document (CTD)Common Technical Document (CTD)

• Development of the technical Development of the technical Development of the technical Development of the technical

requirements based on the harmonized requirements based on the harmonized requirements based on the harmonized requirements based on the harmonized

CTD CTD CTD CTD

• Operationalization of the Operationalization of the Operationalization of the Operationalization of the 7 Expert

Working Groups (EWG)

• Recruitment of MRH Project Staff

Progress attainedProgress attainedProgress attainedProgress attainedRegionRegionRegionRegion Economic Community of West African States (ECOWAS) and Economic Community of West African States (ECOWAS) and Economic Community of West African States (ECOWAS) and Economic Community of West African States (ECOWAS) and

the West African Economic and Monetary Union (WAEMU)the West African Economic and Monetary Union (WAEMU)the West African Economic and Monetary Union (WAEMU)the West African Economic and Monetary Union (WAEMU)

Communique signed by 15 heads of ECOWAS National Regulatory Authorities on 3rd July 2014

10

Southern Africa Development Southern Africa Development Southern Africa Development Southern Africa Development Community (SADCCommunity (SADCCommunity (SADCCommunity (SADC))))Progress attainedProgress attainedProgress attainedProgress attainedRegionRegionRegionRegion

DfiD-funded collaboration initiative between Zambia, Zimbabwe, Botswana and Namibia (ZaZiBoNa) for work-sharing in assessing registrations files submitted by pharmaceutical manufacturers.

Between October 2013 and February 2016, the initiative has:

• Evaluated 116 products, resulting in 46 (40%) products being recommended for registration; and 26 (22%) products recommended for rejection;

• The mean time from assessment to recommendation was 8.84 months, representing both the regulator and applicants’ time.

� March 2011: MRH Framework

Agreed by SADC NMRAs

� October 2013 implementation of

MRH Framework “Breakthrough

Activities” under DfID (SARPAM)

Funding of ZaZiBoNa scheme

� 2014 Official Integration of

ZAZIBONA Scheme into SADC

Framework for Regulatory

Harmonization

� 21-24 July 2015, SADC Regulators

Forum Official Endorsement of

Implementation of MRH

Programme

11

Other Regions: Progress and Priorities…Other Regions: Progress and Priorities…Other Regions: Progress and Priorities…Other Regions: Progress and Priorities…

North/North Eastern Africa

� Dec 2010: Consultation on

AMRH

� 03-05 August 2015, Addis

Ababa, Ethiopia: IGAD

Conference of NMRAs and

partners

� IGAD 2nd Regulators Meeting,

Khartoum, Sudan, April 26-27, 2016

Progress attainedProgress attainedProgress attainedProgress attained

IGAD Call for Action agreed among other things:

• A mechanism for collaboration and harmonization of

regulation of medical products agreed in alignment

with Pharmaceutical Manufacturing Plan for Africa

(PMPA) and the African Medicines Regulatory

Harmonization (AMRH) Initiatives of the African

Union.

• The roles of NMRAs, IGAD Secretariat and collaboration and development partners agreed

• Support the development of an overarching

pharmaceutical policy and the adoption of a modern

legislative framework, based on the AU Model Law.

RegionRegionRegionRegion

Central Africa:

� Regional pharmaceutical policy

in 6 CEMAC Member States

� 1st MRH Project Steering

Committee convened 15-16

November 2016

The Economic and Monetary Community of Central Africa (CEMAC)

• Member States include; Cameroon, Congo

(Brazzaville), Gabon, Equatorial Guinea, the Central African Republic (CAR) and Chad

• In 2013, the Heads of State of the CEMAC member

states adopted the Common Pharmaceutical Policy

(CPP)

• The Organization for the Fight Against Endemic

Diseases in Central Africa (OCEAC) responsible for

coordination of health programmes in the region

AU Model Law on Medical Products Regulation

2009 – 2010: Situation analysis

• Varied comprehensiveness of medicines laws, some laws outdated, mostly territorial in nature

2011: Decision by Pan-African Parliament to come up with a Model Law on Medical Product regulation:

2011- 2015: Model law development process:

• Optional analysis and Drafting

April 2015: Conclusion of regional consultation process involving 5 regions and 47 AU Member States

13-17 April 2015: Consideration by the AU Specialised Technical Committee on Health, Population and Drug Control (STC-HPDC)

November 2015: Considered by the STC on Justice and Legal Affairs

30 - 31 January 2016: Twenty-Sixth Ordinary Session of Heads of State & Government of AU

• adopted the AU Model Law & called upon Member States to act as expeditiously as possible to enable the domestication of the model law at national level

Countries adopted and/or adapted before AU endorsement e.g. Ivory Coast, Zimbabwe, Lesotho, United Republic of Tanzania (Zanzibar), Seychelles and the Gambia.

Partnerships between regulators, academia and/or research institutions to provide systematic and structured

regulatory science training with a view to increase regulatory workforce in Africa

1 WHO Collaborating Centre for Advocacy and Training in Pharmacovigilance; University of Ghana Medical

School - RCORE in Pharmacovigilance

2 Kilimanjaro School of Pharmacy; St. Luke’s Foundation Tanzania - RCORE in training in core

regulatory functions

3 WHO Collaborating Centre for the Quality Assurance of Medicines NWU - Potchefstroom Campus South Africa -

RCORE in Quality Assurance and Quality Control of medicines

4 Centre for Drug Discovery, Development & Production University of Ibadan Nigeria - RCORE in training in core

regulatory functions

5 Medicines Control Authority of Zimbabwe (MCAZ) - RCORE in medicine registration and evaluation, Quality

Assurance/Quality Control and clinical trials oversight

6 National Drug Authority (NDA), Uganda - RCORE in licensing of the manufacture, import, export, distribution

and; inspection and surveillance of manufacturers, importers, wholesalers and dispensers of medicines

7 Direction General de la Pharmacie du Medicament et des Laboratoires / University of Ouagadougou Burkina Faso -

RCORE in clinical trials oversight

8 Food & Drugs Authority (FDA) Ghana - RCORE in medicine evaluation and registration and clinical trials oversight

9 Pharmacy & Poisons Board (PPB) Kenya - RCORE in pharmacovigilance

10 Tanzania Food & Drugs Authority (TFDA) / School of Pharmacy Muhimbili University of Health and Allied Sciences

(MUHAS) - RCORE in medicine evaluation and registration

11 National Agency for Food and Drug Administration and Control (NAFDAC) Laboratory – RCORE in Quality Assurance

and Quality Control of Medicines

ChallengesChallengesChallengesChallenges

�Human resource and financial constraints at the national and regional level

�Heterogeneous starting point of NMRAs

�Sovereignty concerns related with reliance between member-states

�Engagement of local manufacturing industry – harmonized procedures imply an alignment with WHO international quality standards with increased stringency

�Broad bilateral and multi-lateral partnerships

Path ForwardPath ForwardPath ForwardPath Forward

African Union VisionAfrican Union VisionAfrican Union VisionAfrican Union Vision

54 countries 1 continent

African

Medicines

Agency

5regions

IGAD / AMU

/ CEN-SAD

EAC

SADC/

COMESA

ECCAS/

OCEAC

WAHO /

UEMOA

West Africa

Medicines

Agency

East African Community

Medicines and Food

Safety Commission

16

AMA Milestones:AMA Milestones:AMA Milestones:AMA Milestones:• January 2015 AU Executive Council Decision on AMRH as a January 2015 AU Executive Council Decision on AMRH as a January 2015 AU Executive Council Decision on AMRH as a January 2015 AU Executive Council Decision on AMRH as a

foundation for AMAfoundation for AMAfoundation for AMAfoundation for AMA

• Third AMA Third AMA Third AMA Third AMA Task Task Task Task Team, 03 Dec 2016, Cape TownTeam, 03 Dec 2016, Cape TownTeam, 03 Dec 2016, Cape TownTeam, 03 Dec 2016, Cape Town

• Legal, institutional framework and business plan drafted Legal, institutional framework and business plan drafted Legal, institutional framework and business plan drafted Legal, institutional framework and business plan drafted

• AUCAUCAUCAUC, WHO & NEPAD Agency Joint Secretariat , WHO & NEPAD Agency Joint Secretariat , WHO & NEPAD Agency Joint Secretariat , WHO & NEPAD Agency Joint Secretariat

• 2018: AMA Launch2018: AMA Launch2018: AMA Launch2018: AMA Launch

Thank youThank youThank youThank you