Weak or nonexistent regulatory standards among African countries have created lengthy medicine registration processes that can lead to delays of up to seven years in approval decisions, though a new review shows that the harmonization of regulations across Africa has progressed.
The African Medicines Regulatory Harmonization Initiative (AMRH), launched in 2009 with initial funds from the Bill and Melinda Gates Foundation and overseen by the World Bank, “has contributed to reduce marketing authorization timelines in East African Community and the Southern African Development Community member states,” researchers from the South Africa-based University of Witwatersrand wrote in their review article in KEI’s Medical Research Archives
More than 85% of sub-Saharan Africa now includes some medicines registration harmonization projects, the researchers found, though there have been problems associated with substandard drugs, as the vast majority of drugs are imported to the continent, and implementation of effective regulations in some countries has been difficult.
In terms of strengthening regulatory capacity, the researchers highlighted eight different regulatory functions that are being addressed by 11 regional centers of regulatory excellence in Ghana, Kenya, Tanzania, Nigeria, South Africa, Zimbabwe, Uganda and Burkina Faso.
The focus of such efforts has included projects on: Pharmacovigilance; training in core regulatory functions; quality assurance and control; medicine registration and evaluation; licensing of manufacturing, imports, exports and distribution; and clinical trials oversight.
Researchers note that challenges “still exist in using the outcome of the regional joint dossier review processes for national decision making processes by the national medicines regulatory agencies.”
They also discuss how the work that’s being undertaken can serve as a foundation for a pan-African regulator, to be known as the African Medicines Agency (AMA).
“AMA does not seek to replace NMRAs’ [national medicines regulatory authorities] national sovereignty, instead it will complement NMRAs, RECs [regional economic communities] and RHOs’ [regional health organizations’] efforts in the process of establishing an enabling environment for the development of the pharmaceutical industry though better coordination of different partners and stakeholders undertaking medicines regulatory strengthening and harmonization efforts on the continent,” they write.
The African Medicines Regulatory Harmonization Initiative: Progress to Date