Africa’s medicines regulation gains momentum with landmark Green Book listings

PATH congratulates AUDA-NEPAD and the African Medicines Regulatory Harmonisation (AMRH) Initiative on the successful assessment and listing of five human medicinal products under the Continental Procedure for Evaluation and Listing of Human Medicinal Products in the AMRH Green Book. This recently launched AMRH Green Book is a publicly available resource that provides information on medicines scientifically evaluated for safety, efficacy, and quality and supports national marketing authorization decisions across African Union (AU) member states.

The listing of five human medicinal products under the Continental Procedure for Evaluation and Listing of Human Medicinal Products is a major step forward in strengthening Africa’s regulatory systems by enhancing transparency and ensuring African member states, national regulatory authorities, health care providers, and pharmaceutical companies have access to relevant information and data on the medicines compositions, approval process, and key scientific details. It further underscores the power of harmonized registration processes and highlights Africa’s growing capacity to independently conduct high-quality scientific evaluations, an essential foundation for the African Medicines Agency (AMA).

PATH remains committed to strengthening health systems across Africa and is a key partner supporting AUDA-NEPAD through its advocacy for AMA and collaborating with AMRH on the African Union Model Law on Medicinal Products. As part of this partnership, PATH has played a critical role in aligning national regulatory frameworks with continental procedures.

The progress achieved through AMRH’s efforts marks a defining moment for Africa’s regulatory landscape. This milestone brings the continent closer to a fully functional, efficient, and self-sustaining regulatory system by fostering greater coordination and alignment across member states.

As Africa takes charge of its pharmaceutical future, strengthened regulatory capacity will ensure that lifesaving medical products reach those who need them most. PATH is proud to stand alongside AUDA-NEPAD and AMRH in this journey toward a healthier Africa.