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AMRH

INSIDE THIS ISSUE

AFRICAN MEDICINES REGULATORY HARMONISATION PROGRAMME


I S S U E 8 A P R I L J U N E 2 0 1 2

NEWS LETTER

MESSAGE FROM THE PARTNERS


Welcome to the eighth issue of the AMRH Newsletter! The first quarter of 2012 was momentous for the stakeholders and partners of the AMRH Programme. During this period a number of key events took place including the Launch of the East African Community (EAC) Medicines Registration Harmonisation (MRH) Project; the AMRH Stakeholders Consultation, the inaugural AMRH Programme Advisory Committee meeting, and a Roundtable meeting of experts on The role of NMRAs and academic institutions in the institutionalization of regulatory training programmes in Africa using existing regional structures. At the above launch events which occurred in March in Arusha, Tanzania, the message from all the AMRH partners was consistent: that regional harmonization takes a significant amount of time to come to fruition and as such sustained commitment from all stakeholders is necessary. All stakeholders are called upon to join forces to effectively coordinate efforts to support the AMRH initiative in general and to support the EAC/MRH project's implementation in particular, which is pioneering and will set an example for other regions in Africa to undertake similar efforts. Other updates include the 5th Meeting of the Technical Committee for the Pharmaceutical Manufacturing Plan for Africa (PMPA) which also took place during this quarter from 2 -4 May,2012 in Addis Ababa Ethiopia, with the aim of reviewing and finalizing the PMPA Business Plan. At this occasion, partners restated commitment to support the implementation of the PMPA as well as the importance of clear strategies with which to strengthen to document and ensure the implementation the Business Plan. (More on this overleaf). Thank you for your support and we look forward to our continued collaboration!

First Steering Committee Meeting for the EAC/MRH Project Launch of the EAC/MRH Project AMRH Stakeholders Plenary Consultation, 29 March 2012, Arsha, Tanzania Roundtable meeting of experts on The role of NMRAs and academic institutions in the institutionalization of regulatory training programmes, 31 March 2012 First Advisory Committee Meeting for the AMRH Programme Update on the Initiative on the Model Law on Medicines Regulation Harmonization. 5th Meeting of the Technical Committee for the PMPA

Let Us Hear From You! We are inviting all readers and AMRH stakeholders to tell us what they would like to read more of in this quarterly Newsletter. We would very much like to hear from you, and encourage you to send your thoughts to email: amrh@nepad.org

The First Steering Committee Meeting for the East African Community (EAC) Medicines Registration Harmonisation (MRH) Project, Bujumbura, Burundi.
Following the successful launch of the East African Medicines Regulatory Harmonization Project early this year, the first meeting of the EAC Regional Steering Committee (RSC) took place in Bujumbura starting on May 28, 2012 over a two-day session. The Project Steering Committee which is responsible for technical oversight of the EACMRH project activities is comprised of Heads of National Medicines Regulatory Authorities and Chief Pharmacists from EAC Partner States, and is set to meet semi-annually to review progress. Representatives from the African Medicines Regulatory Harmonisation Programme (AMRH) Partners are also represented in committee meetings when required, while the EAC Secretariat serves as the secretariat to this committee. (Contd overleaf)

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The First Steering Committee Meeting for the East African Community (EAC) Medicines Registration Harmonisation (MRH) Project, Bujumbura, Burundi (Contd.)
The meeting was convened in order to: Review and approve the calendar of activities for the period of June to December 2012 Review and approve terms of reference of the steering committee and four technical working groups (TWGs): TWG on common technical document (CTD); TWG on Good Manufacturing Practice (GMP); TWG on Information Management System (IMS); and TWG on Quality Management System Review and approve terms of reference for procurement of various consultancy services Receive reports of implementation of various activities at EAC Secretariat related to the project; and Receive progress report of implementation of priority activities for the EAC MRH Programme including recruitment of staff at regional and national level.

In addition, the meeting was convened to consider and approve implementation of the recommendations from the high level official launch of the EAC-MRH project, AMRH plenary stakeholders consultation and Advisory Committee meeting. To access a copy of the meeting report including other relevant documents please visit: www.amrh.org

Successful launch of the East African Community (EAC) Medicines on 30 March 2012, Arusha, Tanzania.
The NEPAD Agency and the East African Community, in collaboration with the African Medicines Regulatory Harmonization (AMRH) Programme partners, - the World Health Organization (WHO), the Bill & Melinda Gates Foundation, the World Bank, UK Department for International Development (DfID), and the Clinton Health Access Initiative (CHAI), hosted the launch of the East African Community (EAC) Medicines Registration Harmonization (MRH) Project at Ngurdoto Mountain Lodge, Arusha, Tanzania. Over 200 participants gathered at this occasion, including high-level delegates and officials from the Pan-African Parliament (PAP), African Union Commission (AUC), the NEPAD Agency, EAC Sectoral Council of Ministers of Health, Partner states' Ministries of East African Community Affairs and Health including National Medicines Regulatory Authorities (NMRAs) and National Parliamentary Health Committees and international donor agencies supporting the AMRH initiative. Additionally, representatives from other regional economic communities (RECs) in Africa, regional pharmaceutical manufacturing associations, civil society organizations and product development partnerships (PDPs) were represented at the event. In his Keynote Address delivered by telecast, Dr. Ibrahim Assane Mayaki, CEO of the NEPAD Coordinating and Planning Agency (NPCA) noted that transparent, harmonized systems have the potential to remove barriers to the movement of pharmaceutical products. Dr Mayaki thanked the leadership of EAC community for setting the trend for the AMRH initiative which will assist other RECs in learning and drawing on experiences. He confirmed that the development of the pharmaceutical sector is a high priority on the agenda of the African Union. For more information please visit http://www.amrh.org/ newsroom/news.php Amb. Dr. Richard Sezibara, Secretary General, EAC and Prof .Aggrey Ambali, Advisor, NEPAD Agency (NSTIH) in discussion during the launch

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AMRH Stakeholders Plenary Consultation successfully held on 29 March 2012 in Arusha, Tanzania.
The AMRH Programme Stakeholders Plenary meeting took place on 29 March 2012, convening 104 participants. constituting representatives from: National Government Representatives, EAC Legislative Assembly Representatives, academic and research institutions, Regional Economic Communities and AU Organs, International Organizations, Development Partners including Product Development Partnerships and Stringent Regulatory Authorities, Pharmaceutical Manufacturing Associations including Sub-regional Associations, Civil Society/NGOs Representing Health/Medicines Access Initiatives and representatives from the EAC secretariat. During this meeting, participants partook of high quality information exchange including through technical presentations and also discussions on developing the way forward for medicines regulatory harmonization in Africa. A summary report has been finalized and is available at the URL: http://www.amrh.org/documents/index.php or please send requests for the report in pdf format to email: amrh@nepad.org

Roundtable meeting of experts on the role of NMRAs and academic institutions in the institutionalization of regulatory training programmes in Africa using existing regional structures, held on 31 March 2012, Arusha, Tanzania.
The Roundtable meeting of experts was successfully held on 31 March in Arusha, Tanzania, to critically discuss a concept note on The role of NMRAs and academic institutions in the institutionalization of regulatory training programmes in Africa using existing regional structures.The meeting regrouped 33 representatives ranging from National Medicines Regulatory Authorities, government representatives, academic and research institutions, AU Organs, Regional Economic Communities to Stringent Regulatory Authorities (SRAs), Product Development Partnerships (PDPs) Non Governmental Organizations, Development partners including members of the AMRH Consortium; Bill and Melinda Gates Foundation and the World Bank. This provided the opportunity for a rich exchange of ideas and brainstorming around key issues. NEPAD Agency shall finalise the concept note on the role of NMRAs and academic institutions in the institutionalization of regulatory training programmes in Africa, taking into account all the input received. Once the concept note has been finalised by end of April, NEPAD Agency shall draft a project proposal to assist in resource mobilization. In addition, the mapping exercise will be included as part of the project proposal given that it is an extensive exercise that requires substantial resources. A report of the proceedings has been finalized and is available at this link: http://www.amrh.org/documents/index.php

Inaugural AMRH Programme Advisory Committee meeting convened on 30 March 2012, Arusha, Tanzania.
On 30 March 2012 the inaurugal meeting of the AMRH Programme Advisory Committee took place in Arusha, Tanzania, with discussions focusing on the Terms of Reference, roles and responsibilities for the committee members; a review of the African Medicines Regulatory Harmonization (AMRH) Programme; highlights on the EAC MRH Project and a presentation of the NEPAD Agency AMRH Strategic Plan. The Advisory Committee whose role is to advise on the AMRH Programme was constituted by members representing global stakeholders, African Union (AU) organs, Regional Economic Communities and National Medicines Regulatory Authorities (NMRAs) from respective regions. The occasion provided an opportunity for key stakeholders to discuss and review the membership, the Terms of Reference, receive clarification on the same and examine a range of other fundamental issues around the AMRH Programme in order to ensure good governance. The committee will convene once a year with an additional virtual meeting based on identified needs. For more information please visit: http://www.amrh.org/documents/index.php

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Initiative on the Model Law on Medicines Regulation Harmonization.


One of the main challenges in the implementation of AMRH is the absence comprehensive laws (or the existence of weak laws) required to empower countries to effectively regulate medicines as well as facilitate harmonization of regulatory standards and practice among counties through the existing regional structures. Inadequate medicines legislation in many countries in Africa hampers access to quality pharmaceutical services. An analysis of the comprehensiveness of the medicines legislations in various African regions through a NEPAD Agency commissioned situation analysis carried out in 2010 shows numerous gaps in legislations and legal frameworks. While some countries have legislation in line with the core elements as recommended by WHO, others either do not, or have very limited medicines legislation in place. Based on this background, consultative meetings were held with the Pan African Parliament (PAP) AMRH Champions in the Committee on Health, Labour and Social Affairs in June 2011. The recommendation from this meeting among others was that a Model Law be drafted that will assist RECs and/or countries in their endeavor to enact or review country national laws and serve as a reference guide to African RECs and countries in their efforts to harmonize medicines regulation and subsequent harmonization of national laws with regional policies, protocols and treaties. Regional consultative meetings were therefore held with the representatives of the following organizations for the same purposes: West African Health Organization (WAHO); World Health Organization Regional Office for Africa, (WHO-AFRO); World Health Organization Regional Office for East Mediterranean (WHO-EMRO); East African Community (EAC); East African Legislative Assembly (EALA) and the African Union Commission (AUC). This approach ensured that the major stakeholders and Partners including the African Union Organs have been consulted and their input considered in the initial stages of the drafting of the Model Law. In addition, the consultation assisted in providing guidelines on what options will be best to get the finalized Model law widely used by all Africa countries for the purposes of Medicines Regulation. During the first quarter of 2012, a consultant was commissioned by NEPAD Agency to draft a Preliminary Model Law on medicines regulation harmonization in Africa. This draft model law will be presented to the Pan African Parliament (PAP) Committee on Health, Labour and Social Affairs on 26th August, 2012 and thereafter a stakeholders consultation will be held in November, 2012 to solicit views and foster ownership. Please send comments to: amrh@nepad.org Please visit: http://amrh.org/activities/activity03.php

5th Meeting of the Technical Committee for the Pharmaceutical Manufacturing Plan for Africa (TCPMPA).
At the 5th Session of the AU Conference of Ministers of Health (CAMH5) held in Windhoek, Namibia in April 2011, the AU Commission with relevant partners were directed to expedite the processes of developing a business plan to operationalize the PMPA. At this occasion the terms of reference and membership of the Technical Committee of the PMPA were also expanded. Following on from this directive, the AUC organized the 4th Meeting of the Technical Committee of the PMPA from 14-15 December 2011, at which the inaugural meeting of the expanded committee took place. The technical committee reviewed among other issues, the implementation plan of the PMPA, the inception report of the Business Plan of the PMPA, and the draft outline work-plan for the TCMPA. ( contd overleaf)

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5th Meeting of the Technical Committee for the Pharmaceutical Manufacturing Plan for Africa (TCPMPA) (Contd.)
Following on from this, the 5th Meeting of the Technical Committee for the Pharmaceutical Manufacturing Plan for Africa (PMPA) took place from 2-4 May, 2012 in Addis Ababa Ethiopia, with the aim of reviewing and finalizing the PMPA Business Plan. The objectives of the meeting were as follows: -Developing a coordination mechanism for programmes intervening in the pharmaceutical sector in Africa -Reviewing the draft business plan for operationalization of the Business Plan for the PMPA -Identifying key action and results areas for the next steps The action points from the meeting included to submit the report of the CAMH to the AU Summit in July 2012; to hold stakeholder consultations (RECS etc.); to implement a resource mobilization plan to mobilize adequate resources in support of the roll out of the Business Plan and to present the Implementation plans to CAMH 6 in the early part of 2013. In the run up to this a Partners Meeting was held on 2 May 2012 with the following objectives: To inform partners on the progress thus far regarding the implementation of the PMPA by the AUC To facilitate information sharing and guide programme decision making amongst different partners intervening in the pharma sector in Africa To propose a framework to strengthen coordination and create necessary synergies amongst the various pharma initiatives that are on-going on the continent.

Partners in attendance included UNAIDS, COHRED, WHO-AFRO, WHO-EMRO, UNIDO, WAPMA, SAGMA, NEPAD Agency, Department of Social Affairs, AU medical services directorate and the Department of Trade and Industry. Other

Upcoming Events of Interest


July 17-18 July 2012, 3rd Meeting of the Committee on Understanding the Global Public Health Implications of Counterfeit Medicines, Washington D.C. USA. 22-27 July 2012, International Aids Conference, Washington D.C., USA. (Read More) For more information please: http://www.aids2012.org/] 23-25 July 2012, Medicines Evaluation and Registration, Tanzania. 30 July - 1st August 2012, Technical Working Group on Good Manufacturing Practices, Uganda. 30-31 July 2012, Meeting on Affordable Access to Diagnostics, Nairobi, Kenya. August 6-8 August 2012, EAC Technical Working Group on Information Management System (IMS), Kigali, Rwanda. 27-29 August 2012, EAC Technical Working Group on Quality Management System (QMS), Nairobi, Kenya. 20 Aug 14 Sep 2012, Review of existing national Pharmaceutical policies, legislation and regulations in EAC Partner States, location to be confirmed.
26 Aug 2012, PAP Consultation meeting, Model Law on Medicines Regulation Harmonization in Africa.

September 17-21 September 2012, Training of Trainers on risk based approaches and QMS Zanzibar, Tanzania 24-28 September, 2012, Training on Drug Registration: Filing and Reviewing a PEPFAR Application with the US-FDA, Kilimanjaro, Tanzania.

AMRH CONTACTS
AMRH Tel: (office) +27-12-841 4979/3294 Email: amrh@nepad.org NEPAD Agency Prof. Aggrey Ambali Advisor, NSTIH Tel (office): +27-12-841-3688 Aggrey@nepadst.org Mrs. Margareth Ndomondo-Sigonda AMRH Programme Coordinator Tel (office): +27-12-841-2980 Mnsigonda@nepadst.org BMGF Dr. Vincent Ahonkhai Senior Regulatory Officer Tel (office): +1-206-709-3715 vincent.ahonkhai@gatesfoundation.org Mr. James T. Platts Associate Programme Officer Global Health Delivery Tel: (office) +1-206-709-3389 James.platts@gatesfoundation.org 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 azatyans@who.int WHO - AFRO Dr Ossy MJ Kasilo Acting Programme Area Coordinator, Essential Medicines and Health Technologies and Regional Advisor for Traditional Medicine Health Systems Strengthening Cluster Tel: +47 241 39268 kasiloo@afro.who.int Professor Jean Baptiste Nikiema EDMai/AFRO nikiemaj@afro.who.int WHO - EMRO Dr. Mohamed BIN SHAHNA Regional Advisor Essential Medicines Tel (office): +202-227-65561 binshahnam@emro.who.int World Bank Dr. Ramana NV Gandham Lead Health Specialist, Africa Region Tel: (office) +254-20-3226376 na@worldbank.org DFID Dr. Shaun Conway Programme Director Southern African Regional Programme on Access to Medicines & Diagnostics (SARPAM) Tel: (office) 0118806993 shaun@human-scale.net UNAIDS Dr. Abdoul Dieng, Chief, Policy Coordination, Office of the Deputy Executive Director Tel: (Office) +41227914750, dienga@unaids.org Dr. Eduard Beck Senior Technical Advisor, Office of the Deputy Executive Director, Programme Branch, Tel: (Office) + 41 22 791 5521 Becke@unaids.org Dr. Jean-Elie Malkin Senior advisor to the Executive Director, Tel. (Office) : +41227914714 Malkinj@unaids.org CHAI GramaMs. Meredith C Moore Country Support Manager, Drug Access Team Tel: (Office) +1 617 784 5198 mmoore@clintonhealthaccess.org

Dr. Andreas Seiter Senior Health Specialist - Pharmaceuticals Health, Nutrition and Population

MORE INFORMATION ON THE AMRH PROGRAMME For more information on AMRH please visit the AMRH website: www.amrh.org. The French website will be up and running very soon! This Newsletter is produced by the AMRH Programme team at the New Partnership for Africas Development (NEPAD) Agency in collaboration with AMRH Partners. For additional information please send an email to: amrh@nepad.org

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