The experts have reiterated the urgent need for Africa to fast track the process of harmonizing medicines regulation on the Continent to guarantee access to quality medicines. The issue was front andcenter in the two-day event that brought together experts of the pharmaceutical sector in the framework of the 4th African Medicines Regulatory Conference in Addis Ababa, Ethiopia.
The experts considered recent advances in countries for regulation of medical devices, blood and blood products and in implementation of harmonization programmes in RECs. Moreover, they reviewed and adopted the African Medicines Regulatory Harmonization (AMRH) Implementation Toolkit and the draft Regional strategy for strengthening regulatory systems in the Africa.
Officially closing the Conference on behalf of the Director for Social Affairs, Dr. Janet Byaruhanga, Health Officer at the African Union Commission highlighted the fact that harmonization of medical products regulation is critical to ensure an Africa is free of diseases. However, she emphasized that the realization ofthis very important agenda will require human resources, requisite skills, and establishment of relevant research, academic and financial institutions, as outlined in the African Union’s Agenda 2063.
“The strategies and action plans for regulation of medical products, medical devices, diagnostics, biological products etc., I am sure, will not only serve the needs of the people within the borders of each country but through regional economic communities, willbenefit other African citizens across the continent.”, she said.
The Meeting also underlined the need for Member States to increase national investments for strengthening the regulatory capacity of NMRAs as well as the necessity forpartner organizations including the World Health Organization to provide countries with support to establish, assess and strengthen their regulatory systems taking the benefit of the WHO Global Assessment Tool.
Prof Aggrey Ambali, Head of the NEPAD Technology, Science and Innovation Hub commended the Member States for their commitment to strengthen regulatory capacity of NMRAs and noted that NEPAD will continue to take a leading role in coordinating activities highlighted during the Conference. “We [NEPAD Agency] commit to doing what you as AU Member States have requested us to do, we acknowledge that as an African led institution, we continue to provide leadership in facilitating and coordinating activities related to strengthening Medicines Regulation at National, Regional and Continental level” he said.
Dr. Ossy Kasilo, Programme area coordinator for Essential medicines and health technologies at WHO regional office for Africa reiterated WHO’s commitment to this process. “We reiterate WHO’s commitment to continue to work with partners such as NEPAD, AUC, BMGF, the World Bank, USAID and others to support countries in strengthening regulatory systems for medical products and supporting the process of alignment between AVAREF and AMRH Program. We look forward to working together as a team in the implementation of the recommendations of both conferences.” she said.
The 4th African Medicines Regulators Conference was preceded by the 2nd Biennial scientific conference on medecines regulations in Africa from 30th November to 1st December 2015 in Addis Ababa. These meetings took place in the wake of the Pharmaceutical Manufacturing Plan for Africa which was adopted in 2005 to facilitate the emergence of a local pharmaceutical industry on the continent.