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African Regulatory Harmonization Efforts Making Progress, But Weaknesses Need Addressing

 
• By Ian Schofield

Greater use of reliance procedures and improving alignment among the various operating models of African regulatory bodies will lead to more efficiency and strengthen the foundations of the future African Medicines Agency, a regulatory conference heard.

Africa flags on the map
Africa is striving to align its national and regional regulatory requirements • Source: Shutterstock

Drug regulatory initiatives in three of the main African regional economic communities (RECs) are making progress in areas such as harmonization of registration requirements, capacity building and information, while most national regulatory agencies are using some form of reliance procedure when dealing with marketing authorization applications.

However, these regional initiatives have a number of weaknesses such as the lack of a centralized dossier submission and tracking system, an unequal spread of the workload among national regulatory...

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