Addis Ababa, Ethiopia, 30 November, 2015: The 2nd Biennial scientific conference on medicines regulation in Africa has opened today 30 November, 2015 in Addis Ababa, Ethiopia under the theme “Regulatory Systems Strengthening for advancing Research, Innovation and Local Pharmaceutical production in Africa”.

This second Conference has brought together more than 300 representatives from African National Medicines Regulatory Authorities (NMRAs), foreign NMRAs and ethics committees/ Institutional Review Boards (IRB), industry representatives, regulatory affairs professionals, scientists, academia, health financing specialists, and development partners in health and pharmaceutical Sectors in Africa. The various stakeholders will discuss how to strategically position medical products regulatory systems as a key aspect in facilitating research and development and local production of the needed medical products for diseases affecting the people of Africa.

Ambassador Dr. Olawale Maiyegun, Director of social affairs at the African Union Commission, addressing the participants argued that the second biennial aims to advance the African Union Agenda 2063 and the Post 2015 Development agenda which are the new continental frameworks for development in Africa. The Director also urged participants to keep the collaborative spirit and commitments that the member states, Regional Economic Communities and partner Agencies demonstrated during the 6th Technical Committee on the Pharmaceuticals Manufacturing Plan for Africa that took place from 28 to 29 November 2015. “The African Union Commission recognizes the importance of Science, Technology and Innovation are key ingredients for the advancement of any sector of development. We highly value your work and your deliberation will contribute substantively to this effort.”, Dr. Maiyegun emphasized.

Prof. Aggrey Ambali, from the New Partnership for Africa’s Development Planning and Coordinating Agency, welcomed all participants and focus his statements on the biennial, which is a window of opportunity to emphasize the need to strengthen the regulatory systems based on scientific evidences. He also described it as an important platform in sharing experiences and advancing and contributing to the achievements of the Agenda 2063.
Mrs. Margaret Ndomondo-Sigonda, Coordinator of Pharmaceuticals at New Partnership for Africa’s Development Planning and Coordinating Agency, commended the African Union Commission for the convening of this meeting, very critical in the process of fast tracking the establishment of a robust regulation of medical products and technologies. Moreover, she expressed her gratitude to the Organizing Committee composed of the World Health Organization Regional Office for Africa (WHO/AFRO), the Eastern Mediterranean Regional Office (WHO/EMRO), the African Union Commission and NEPAD Planning and Coordinating Agency for the collaborative spirit, which made possible the meeting.
Mrs. Ossy MJ Kasilo, Coordinator of Essential Medicines and Health Technologies World Health Organization (WHO) at the Regional Office for Africa, noted that the Biennial Scientific Conference is a networking platform established to facilitate exchange of information on innovative approaches that can further advance the pharmaceutical sector in the African continent. She also highlighted the fact that it the meeting is a window of opportunity to achieve the vision of “An integrated and prosperous Africa free of its heavy burden of diseases, disability and premature death” and, as a consequence, the achievement of the WHO vision of “attainment by all peoples of the highest possible standard of health."

In the same vein, Hon. Dr. Bala Saratou, Chair of the Committee on Health, Labour and Social Affairs at the Pan African Parliament (PAP), pointed to the fact that the issue of Medicines Regulation was central to the concerns of the Pan African parliament since 2009. Dr. Bala Saratou recalled that the Pan African legislative body was at the forefront regarding the establishment of model-law on Medicines Regulation. In that regard, the members of the PAP Committee on Health, Labour and Social Affairs attended a workshop in 2011 to reinforce their capacities in order to undertake advocacy and campaigning activities at national and regional levels. She concluded by underlining the urgent need for strong and robust collaboration at all levels to Medicines Regulation that will improve the health of the African people.

Mr. Nazeem Mohamed, representing the Federation of African Pharmaceuticals Manufacturers Association (FAPMA) argued that regulation is the 3rd priority of the manufacturers agenda on the Continent. In order to implement that priority, FAPMA is working closely with regulators and WHO to ensure the people access safe, quality efficacious medicines. He also announced a roadmap to help countries in strengthening their regulatory systems.

Mr. Apollo Muhairwe, speaking on behalf the World Bank Group, highlighted the active participation of the Bank in the Africa Medicines Regulatory Harmonization (AMRH) program. He emphasized that the Bank acts as Trustee for the Multi Donor Trust Fund that was created for this purpose and we are responsible for the fiduciary oversight of the program. “Through the work methods outlined earlier, the Bank supports the AMRH, leveraging on the existing Regional Economic Communities (RECs), to strengthen systems and processes of regulatory functions within the NMRAs. Thematic areas were identified and constituted the key indicators of success: Medicines Evaluation and Registration (MER), current Good Manufacturing Practices (GMP), Information Management Systems (IMS) and Quality Management systems (QMS).”, Mr. Apollo Muhairwe said.

Dr. Dan Hartman from Bill& Malinda Gates Foundation reiterated the full commitment of his organization to clinical development and medicines regulation around the world. He recalled that Bill& Malinda Gates Foundation was a founding partner of the Vaccine Alliance (GAVI) and has made several commitments to GAVI through direct funding. He also mentioned that they have registered tremendous progress, especially in the East Africa Community (EAC) in the pharmaceutical area and this progress should be extended to the other regions.

It is worth recalling that the First Biennial Scientific Conference on Medicines Regulation in Africa jointly organized by the AU/NEPAD Agency’s African Medicines Regulatory Harmonization (AMRH) Initiative and the World Health Organization (WHO) was held in Johannesburg, South Africa, 2-3 December 2013. The Conference was organized under the theme “Building Partnerships for Sustainable Capacity in Medicines Regulation in Africa”.

For more information, please contact:

Janet Byaruhanga | Health Officer, Social Affairs Department | African Union Commission I E-mail: ByaruhangaJ@africa-union.org Tel: +251115182226
George Makateto | Social Affairs Department E-mail: African Union Commission I E-mail: gmakateto@yahoo.com

Ricardo Dunn | NEPAD Agency I E-mail:ricardod@nepad.org | Tel: (+27) 11 256 3600
For Media inquiries contact:
Wynne Musabayana | Deputy Head of Division | Information and Communication Directorate | African Union Commission | Tel: (251) 11 551 77 00 | Fax: (251) 11 551 78 44 | E-mail: MusabayanaW@africa-union.org | Web: www.au.int|Addis Ababa | Ethiopia