Establishment of the African Medicines Agency: progress, challenges and regulatory readiness

Table 1 Level of implementation of regulatory functions at national, regional and continental level [11]

Regulatory function	NMRA	Regional harmonisation	AMA
Registration of medical products	X	X^a	NA
GMP inspection of manufacturers	X	X^b	X^c
Inspection of supply chain (importers, wholesalers, retailers)	X	–	–
Post-marketing surveillance	X	X^d	X^d
Pharmacovigilance	X	–	–
Regulation of clinical trials	X	X^e	X^f
Quality control	X	–	–
Medicine information	X	–	–

^a In some RECs, centralised registration may not be feasible as it is dependent on specific regional contexts. In addition, centralised registration will only be for selected products for which centralised registrations would offer a comparative advantage
^b The majority of NMRAs do not have the resource capacity to perform GMP inspections. Therefore, this function can ideally be done at both the national and regional level, though NMRAs have the final approval
^c In African countries, GMP inspections of API manufacturers, biologics and vaccines is virtually non-existent. Therefore, this function can ideally be coordinated and conducted at the continental level, though NMRAs have the final approval
^d Regional agencies and the AMA have the role of coordinating and facilitating information exchange at national, regional and continental level, particularly for SF medical products
^e Review and/or coordination of regulatory oversight of multi-country clinical trials
^f Regulatory guidance and/or coordination of regulatory oversight of clinical trials for investigative and innovative therapies (e.g. for pandemics such as Ebola and COVID-19)

ISSN: 2052-3211