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AMRH
AFRICAN MEDICINES
REGULATORY HARMONISATION
PROGRAMME
IN THIS ISSUE
NEWSLETTER
ISSUE 10
African Regional Medicines Registration
Harmonisation mid-year update
•
African Regional
Medicines
Registration
Harmonisation
mid-year update.
•
Bridging medicines legislation
gaps in Africa.
•
The 1st Biennial
Scientific
Conference on
African Regulatory,
2-3 December,
2013, Johannesburg , South Africa
•
Joint African Drug
Regulatory
Authorities and
Eastern Mediterranean Drug
Regulatory Authorities Conference, 4-6 December, Johannesburg, South Africa
•
Regulatory
Capacity
Development in
Africa
•
Upcoming Events
Across Africa, medicines regulatory
harmonisation continues to rise
higher on national and regional
agendas with significant progress
being made by the East African
Community (EAC), West African
Health Organisation (WAHO) and
West African Economic and Monetary Union (UEMOA) since the beginning of 2013.Continued technical,
political and financial support provided by NEPAD Agency, World
Health Organisation (WHO) and the
World Bank was instrumental in the
success of the regional medicines
registration harmonisation projects.
It is evident that through partnerships, African citizens will reap the
benefits of the African Medicines
Regulatory Harmonisation (AMRH)
Initiative. Dr. Ibrahim Mayaki, CEO
of NEPAD Planning and Coordinating Agency said during his official
visit to Tanzania Food and Drugs
Regulatory Authority (TFDA) in
March 2013 that “African governments and regulatory authorities
need to work together using joint approaches”.
Regional Economic Communities
(RECs) update
EAC made important strides towards
advancing the harmonisation
agenda by establishing2 regulatory
initiatives, namely: Medicines Registration Harmonisation (MRH) project
which was launched in March 2012
and an initiative on Regional Harmonisation of Regulation of Medical
Devices and Medical Diagnostics in
the EAC Partner States. They’ve established four (4) Technical Working
Groups (TWGs) on Medicines
Evaluation and Registration, Good
Manufacturing Practice, Quality
Management System and Information Management System.
development and implementation of
agreed common information management system and quality management systems (QMS) requirements for regulation of medicines &
ISO certification amongst other
things.
ISSUE 10
Page 2
African Regional Medicines Registration Harmonisation
mid-year update (cont.)
The 3rd EAC-MRH Project
Steering Committee will convene
in Bujumbura, Burundi from 2-3
September 2013 to discuss the
MRH implementation progress
report; final guidelines developed by the four 4TWGs; the development of EAC Regional
Pharmaceutical Policy, Regulatory Framework and a Bill for Establishment of EAC Medicines &
Food Safety Commission; and
the initiatives for National & Regional Capacity Building for
Medicines Regulation.
ponents of the medicines registration proposals and have expressed their willingness to collaborate in order to avoid duplication of efforts by their member
states. They’ve agreed that
UEMOA will continue working
with8 Francophone countries,
namely Benin, Burkina Faso,
Guinea-Bissau, Ivory Coast,
Mali, Niger, Senegal and Togo
while WAHO works with the remaining 7 Anglophone and Lusophone countries which are
Cape Verde, Gambia, Ghana,
Guinea, Liberia, Nigeria and Sierra Leone.
A major milestone was reached
in the West Africa region with the
establishment of the Medicines
Registration Harmonisation
(MRH) Steering Committee and
Technical Working Groups at a
workshop convened from 22-23
May in Accra, Ghana by WAHO.
Further, the draft terms of reference and compositions of Expert
Committees were developed,
which will pave way to faster imThroughout the African Medicines Regulatory Harmonisation plementation of the AMRH
(AMRH) Initiative implementation across the region integrating all
period, it has been learned that key stakeholders. These comthough the MRH project develmittees are in the area of:
opment phase takes longer than i) Medicines Dossier Evaluation
anticipated in some instances,
and Registration; ii) Quality Mansome implementation steps can agement Systems and Quality
be taken even before the reControl; iii) Information Managegional MRH Projects are offiment System; iv) GMP and Incially launched. West Africa is a spections; and v) Capacity Buildtestimony to this fact because
ing and Legislation. With
WAHO and UEMOA have
UEMOA as a member of WAHO
started implementing some com- MRH Steering Committee, ex-
change of information, implementation progress and lessons
learnt between these two organisation will surely benefit all Economic Community of West African States (ECOWAS) member
states.
Although Central and Southern
regions are progressing relatively slow, plans are underway
to revive dialogue between
NEPAD Agency and Southern
African Development Community
(SADC) Secretariat in the next
quarter in order to finalize their
MRH project proposal which was
developed in 2011.
Industry Engagement
Industry also played an important role in the progress made in
East and West Africa. At the Assembly of ECOWAS Ministers of
Health on 5th April, 2013 in
Praia, Cape Verde, Ministers
signed a charter for collaboration
between WAHO and pharmaceutical industry which recognizes regional harmonisation as
a critical factor for success.
Industry stakeholders in the EAC
region convened a meeting of
the Federation of East African
Pharmaceutical Manufacturers
(FEAPM) and the EAC-RMPOA
(Regional Pharmaceutical Manufacturing Plan of Action) Steering
Committee in Nairobi where
AMRH Partners successfully
galvanized stakeholder relations
through information sharing
ISSUE 10
Page 3
sessions and discussion on the Manufacturers (FEAPM) form
progress of the EAC MRH in the part of the AMRH Advisory Comregion.
mittee which is the governing
body of the AMRH Initiative.
In recognition of the importance
of industry engagement,
AMRH Advisory Committee
The AMRH Advisory Committee
Federation of African Pharmaheld their annual meeting on the
ceutical Manufacturing Associa- 8th of June 2013 in Nairobi,
tions (FAPMA), West African
Kenya to note the draft AMRH
Pharmaceutical Manufacturers
monitoring and evaluation (M&E)
Association (WAPMA), Southern framework and AMRH ImpleAfrican Generic Medicines Asso- mentation Tool Kit developed by
ciation (SAGMA) and Federation NEPAD Agency for consultation
of East African Pharmaceutical and validation by stakeholders; it
endorsed Regional Economic
Communities (RECs) implementation reports and the establishment of Pan-African Harmonisation Working Party for Medical
Devices and Diagnostics. The
TWG on Regulatory Capacity
Development and TWG on
Medicines, Policy and Regulatory Reforms presented their
progress reports for adoption .
AMRH Advisory
Committee
meeting held on
8 June 2013
Nairobi-Kenya
Bridging medicines legislation gaps in Africa
The lack of comprehensive
medicines legislation in many
countries in Africa remains a
challenge and while some
countries have legislation in line
with the core elements as recommended by the World Health
Organisation (WHO), others do
not have medicines regulatory
laws in place. NEPAD Agency
and Pan African Parliament
have joined forces to support
the medicines regulatory harmonisation in Africa, through the
development of a Medicines
Regulations Model Law that will
assist RECs and/or countries in
to review their national laws and
subsequent harmonisation of
national laws with regional policies, protocols and treaties.
ISSUE10
Page 4
Technical
Working
Group on
Medicines
Policy and
Regulatory
Reforms
meeting
held
on ...in
Nairobi,
Kenya
A Technical Working Group
(TWG) on Policy and Regulatory
Reforms has therefore been constituted comprising a core team
of regulatory, policy and legal experts that provides technical support and advice on issues of policy and legislation to the Advisory
Committee of the African Medicines Regulatory Harmonisation
(AMRH) initiative. The TWG provides backstopping technical
support on on-going policy and
legal activities within the AMRH
towards achieving the effective
regulation of medicines and
medical products. The TWG
therefore supports countries and
RECs in their endeavor to review
and/or develop policies and
legislation on medicines and
medical products for facilitating
effective regulation
The TWG whose membership
comprises African Union Com-
mission (AUC), Pan-African Parliament (PAP), NEPAD Agency,
World Health Organisation
(WHO): WHO-HQ, WHO-AFRO,
WHO-EMRO, UNAIDS, Federation of African Manufacturers and
Regional Economic Communities
(RECs) convened its inaugural
meeting from 6th to 7th June 2013
in Nairobi Kenya. The main objective of the meeting was to validate the draft model law in
preparation for a presentation to
PAP and thereafter regional and
national consultations.
on the model law.
As a way forward the committee
agreed on an action plan aimed
at addressing some of the policy
and legal issues identified during
the meeting. Two key delivery
areas were agreed upon including
i) Model Law finalization for endorsement by the AU Policy Organs and adoption by the Summit; and
ii) Model Law implementation arrangements by regional economic communities and member
The meeting achieved the follow- states.
Two sub-committees were estabing outputs:
1) The TWG agreed on the final lished that will specifically focus
on tackling each of the identified
TOR prior to submission to
delivery areas. The subthe Advisory Committee.
2) Policy issues were identified committees will report on their
progress to plenary meetings of
and an action plan for addressing them was outlined. the TWG.
3) The TWG discussed and
made detailed comments
ISSUE 10
Page 5
Announcing the 1st Biennial Scientific Conference on
African Regulatory, 2-3 December, 2013, Johannesburg
The NEPAD Agency in collaboration with the World Health
Organisation (WHO) and the
organisational support of
US-Food and Drugs Administration (USFDA) and the Drugs for
Neglected Diseases initiative
(DNDi) is pleased to announce
the First Biennial Scientific
Conference on Medicines
Regulation in Africa, to take
place on 2 and 3 December
2013, at Birchwood Hotel, Johannesburg, South Africa. The
theme of the conference is
“Building Partnerships for Sustainable Capacity Development
in Medicines Regulation in
Africa”.
The initiative to organise this
conference is borne of the necessity for African regulatory authorities, researchers, academic
institutions and industry to work
together to address some of the
salient issues affecting their
areas of delivery of medical
products and technologies to the
public. It is undisputable fact that
most of the African pharmaceutical markets are poorly regulated
which consequently puts public
health at risk and erodes public
confidence on health care delivery systems and specifically on
the quality and safety of medicines they use. In recognition of
this problem, various Governments and partners have
embarked on regulatory capacity
building programmes albeit in
uncoordinated fashion. In addition, various Regional Economic
Communities (RECs) in Africa
have embarked on medicines
regulation harmonisation initia-
tives with a view to increase patients’ access to quality, safe and
efficacious essential medicines
through capacity building
programmes and streamlining
regulatory processes and procedures.
The goal of the conference is to
enable policy makers, regulators,
industry, academia, research organisations and scientists to network and exchange information
on innovative approaches for
pharmaceutical sector
development in Africa.
In addition, an exhibition by pharmaceutical industry and other
stakeholders will also be held on
the sidelines of the conference.
Conference Programme
A range of pertinent issues will be discussed at the conference. Session to be include:
Session II: Global Regulatory Environment: Where is Africa?
Session III: Panel Discussion on Regulatory oversight on clinical trials in Africa: Where are we?
Conference Registration:
Session IV: Panel discussion on situation analysis and legal background for medicines policies and
regulatory reforms in Africa
Session V: Regulatory Capacity Development & Partnerships
Session VI: Panel discussion on substandard & falsified medicines: what is Africa doing to combat
the menace?
Session VII (Parallel): Strengthening Pharmacovigilance Systems in Africa
Session VIII (Parallel): Providing an enabling environment for pharmaceutical production in Africa
For a full programme please visit: www.amrh.org
Conference registration
Registration fee is $50p.p or R450 p.p and free of charge for speakers and invited guests. For more
details on payment for registration and exhibitions please email: [email protected]
ISSUE 10
Page 6
Joint African Drug Regulatory Authorities and Eastern Mediterranean Drug Regulatory Authorities Conference, 4-6 December,
Johannesburg, South Africa
Following the Biennial Scientific conference the WHO Regional Office for Africa (WHO-AFRO) and
WHO Regional Office for the Eastern Mediterranean (WHO-EMRO) will co-host the 3rd African Medicines Regulatory Authorities Conference in collaboration with NEPAD Agency which will also be held
in Birchwood Hotel, Johannesburg on 4-6 December 2013. While the first two African Medicines Regulatory Authorities Conference brought together regulators from sub-Sahara Africa, the third conference
is intended to bring together regulators from sub-Saharan Africa as well as North Africa. For more information please visit: www.afro.who.int and www.amrh.org
Regulatory Capacity Development in Africa
A Technical Working Group
(TWG) on Regulatory Capacity
Development was established by
NEPAD Planning and Coordinating Agency in 2012 and thus far
has done a lot of work to lay out
a foundation and roadmap for
the medicines regulatory capacity development in Africa. It is
clear that effective regulatory capacity development efforts
should target National Medicines Regulatory Authorities
(NMRAs), government, Regional
Economic Communities (RECs),
local research institutions, academia and the private sector
with a goal toward enhancing the
short and long term potential for
these institutions to support governments to lead and manage
regulatory systems in their countries. The approach of the TWG
has been to promote practical
approaches that have the potential to transform the environment
that will foster sustainable regulatory capacity building activities
Regional Centres of Regulatory
Excellence (RCOREs) in Africa;
and v) Discuss preparations for
the 1stScientific Conference on
Medicines Regulation in Africa to
be held in Johannesburg, South
Africa from 2-3 December 2013
and the 3rd African Medicines
Regulatory Authorities Conference from 4-6 December 2013
The second TWG meeting was
held on 6 June 2013 in Nairobi
Kenya. The main objective of the
meeting was to review on-going
TWG activities and to discuss
and endorse several new and
revised draft documents. Specific objectives were to:
i) Review of on-going activities
and the roadmap for regulatory
capacity development in Africa;
ii) Review approaches for harmonizing regulatory science curricula in Africa; iii) Approve the
revised TOR for the TWG Regulatory Capacity Development; iv)
Review progress on establishing
The TWG activities are geared
towards developing the necessary environment that will increase regulatory workforce in
Africa through human resource
and institutional capacity
strengthening. This will ultimately lead to improved competencies and efficiencies of individual regulators and the
NMRAs. Consistent and sustained performance by individual
regulatory affairs professionals
and the regulatory system over a
period of time will lead to effective regulation of medical products and technologies thereby
contributing to socio-economic
development agenda for the African continent.
The TWG thus provides technical
advice on the development and
implementation of sustainable
medicines regulatory capacity
development programmes in Africa in collaboration with partners, research and academic
institutions in support of the
AMRH mission. Key deliverables
of the TWG include; the establishing Regional Centres of
Regulatory Excellence in Africa
using the existing institutions on
the
continent, It is envisaged
that at least each regional economic community will have one
RCORE.
other things, as an interdisciplinary and multidisciplinary area of
specialty, the experts will continue to play an evolving role in
the development of new tools,
approaches and standards for
the assessment of quality, safety,
efficacy and performance of
health products and technologies.
member states and AMRH Programme partners;
iii) Be available to carry out assignments in the African continent for the AU/NEPAD Agency;
Members of the Pool of Regulatory Experts will specifically:
i) Provide technical assistance
on the development and implementation of sustainable medicines regulatory capacity building
A pool of regulatory experts will programmes in collaboration with
also be established and will con- partners and academic institutions in support of the AMRH obstitute a significant resource for
the development of the pharma- jectives;
ceutical sector in Africa in
ii) Carry out technical assistance
particular and promotion of public missions in response to specific
health in general. While the pool requests from African Union
will support the RCOREs among
iv) Share current expertise, information, best practices in their
fields of expertise when called
upon.
UPCOMING EVENTS
SEPTEMBER
•
Regional Project Steering Committee, 2-3 September, 2013, Bujumbura, Burundi
•
Conference on International IVD Medical Devices Regulations, from 16-18 September, Taipei, Taiwan
•
EAC Partner States National stakeholders Consultation meetings, from 16 Sept – 03 October 2013,
Uganda, Burundi, Rwanda, Tanzania and Kenya
•
Africa Pharma Summit, from 23-24 September, Hammamet, Tunisia
•
SCMS Vendor Meeting, from 25-27 September, Johannesburg, RSA
OCTOBER
•
ANDI Stakeholders Meeting, from 1-3 October, Nairobi, Kenya
•
2nd African high-level representatives meeting on the second European and Developing Countries
Clinical Trials Partnership programme (EDCTP2), on 21 October, Dakar, Senegal
•
Workshop on “Ensuring Successful Implementation of Harmonised Medicines Regulation in the
East African Community from 24-26 October, Nairobi, Kenya
Calling for your valued Opinions and Feedback…
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send us your feedback by filling in a brief one page survey attached to the newsletter. Please send responses to
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AMRH CONTACTS
AMRH
WHO - AFRO
Tel: (office) +27 841 4979/3294/2833
Dr Jean-Baptiste Nikiema
Regional Advisor, Essential Medicines, Health
Systems Services.
Tel: +242 050403726
Email: [email protected]
Email: [email protected]
NEPAD Agency
Prof. Aggrey Ambali
Advisor NSTIH
Tel (office): +27-12-841-3688
Email: [email protected]
Dr. Ossy MJ Kasilo
Coordinator, Essential Medicines and Health Technologies Regional Advisor for Traditional Medicine
Health Systems and Services Cluster,
Tel: +242 055 384 162
Email: [email protected]
Mrs. Margareth Ndomondo-Sigonda
AMRH Programme Coordinator
Tel (office): +27-12-841-2980
Email: [email protected]
World Bank
BMGF
Dr. Vincent Ahonkhai
Senior Regulatory Officer
Tel (office): +1-206-709-3715
Email: [email protected]
WHO - Geneva
Dr Samvel Azatyan
Manager, Medicines Regulatory Support Programme, Quality Assurance and Safety: Essential
Medicines and Pharmaceutical Policies
Tel: (office) +41-22-791-3528
Email: [email protected]
WHO - EMRO
Dr. Mohamed BIN SHAHNA
Regional Advisor
Essential Medicines
Tel (office): +202-227-65561
Email: [email protected]
Dr. Ramana NV Gandham
Lead Health Specialist, Africa Region
Tel: (office) +254-20-3226376
[email protected]
Dr. Andreas Seiter
Senior Health Specialist - Pharmaceuticals Health,
Nutrition and Population
Tel: (office) Tel +1-202-473-3629
Email: [email protected]
DFID
Mr. Celestine Kumire
SARPAM Programme Director
Tel: +27 11 880 60993/4
Email: [email protected]
Mr. Joseph Mthetwa
Senior Programme Officer for Health and Pharmaceuticals, SADC Secretariat
Email: [email protected]
Tel: + 267 35 1863
UNAIDS
Dr. Abdoul Dieng,
Chief, Policy Coordination,
Office of the Deputy Executive Director
Tel: (Office) +41227914750
Email: [email protected]
Dr. Eduard Beck
Senior Technical Advisor,
Office of the Deputy Executive Director,
Programme Branch,
Tel: (Office) + 41 22 791 5521
Email: [email protected]
Dr. Jean-Elie Malkin
Senior advisor to the Executive Director,
Tel. (Office) : +41227914714
Email:[email protected]
Mr. Appollo Muhairwe
Operations Officer
Tel: +256414032409/414230094
Email: [email protected]
CHAI
Kathryn Boateng
Consultant
Pharmaceuticals, Health, Nutrition and Population
Email: [email protected]
Ms. Meredith C Moore
Country Support Manager,
Drug Access Team
Tel: (Office) +1 617 784 5198
Email: [email protected]
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editions of the AMRH Programme News Letter; AMRH summary status and future plans; REC Project status, please visit the AMRH website: www.amrh.org. The French website will be up and running very soon!
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