Transitioning to regulatory harmonisation for medicines: a comparison between Africa and Europe

The harmonisation of medicines regulation has varied across regions. Europe began over 50 years ago, whereas Africa started only recently through regional initiatives. We compared regulatory developments in both regions, examining stakeholder influence, philosophy, funding, and systems. Key differences included legislation (common binding legislation was essential to success in Europe), economics, disease patterns, and industrial policy, while protecting health and work-sharing were common goals. Disease outbreaks drove African manufacturing and regulatory strengthening, whereas European harmonisation followed the formation of the European Union. The establishment of the European Medicines Agency in 1995 was crucial, but an African Medicines Agency remains in progress. Both regions require national support for supranational bodies. Africa has advanced in regulation recently, while Europe strengthens its system. Future health challenges require continued harmonisation efforts.