Key Takeaways
- Two cancer drugs and three vaccines have been recommended for approval across Africa under a landmark pilot that was designed to streamline the evaluation of drug applications by national regulators in the continent.
- The continental pilot was designed to foster reliance among the African Union member states and speed up approvals.
- A harmonized regulatory approach across Africa is also expected to streamline processes for pharmaceutical manufacturers, enabling them to scale production and expand market access across the continent.
The cancer drugs Bavencio (avelumab) and Keytruda (pembrolizumab) are among the five products to be recommended for marketing approval in Africa under a landmark pilot that involved regulators
The pilot, led by the African Union Development Agency (AUDA-NEPAD) with the support of the European Medicines Agency and other partners, was designed to address issues of fragmented regulatory systems in Africa, lengthy approval