Medicines Development and Regulation in Africa

Africa is one of the world’s fastest-growing economic regions, with a rise in its pharmaceutical industry value from $4.7 billion in 2003 to $20.8 billion in 2013. Multinational pharmaceutical companies are increasingly active in drug production and clinical trials across Africa, and there is an increasing number of local companies engaged in medicines development and marketing.

Clinical research in sub-Saharan Africa is mainly performed by international and local companies, but increasingly also by clinicians in the form of investigator-initiated trials. There is a clear need for more and better clinical research in Africa addressing the major contributors to burden of disease in this part of the world.

The South African Medicines Control Council (MCC) is the most established regulatory body in Sub-Saharan Africa. In November 2015, the South African parliament passed a bill to phase out the Medicines Control Council and create a new South African Health Products Regulatory Agency (SAHPRA). This Agency has started its first activities in 2017, although its full scope of activities will only be implemented over the next few years. A critical mass of experienced internal and external reviewers will be needed to carry out its mandate.

The expansion of the local pharmaceutical industry and of the regulatory agencies on the African Continent require adequately trained specialists in all fields of pharmaceutical medicine.

A list of available training programmes is already available.

Read the full article “Medicines Development and Regulation in Africa” by Bernd Rosenkranz, Michael Reid and Elizabeth Allen.