The African Medicines Regulatory Harmonisation (AMRH) Programme aims to contribute to the broader AUDA-NEPAD and AU vision and mission. Of particular focus to AMRH is the African Union Pharmaceutical Manufacturing Plan for Africa (PMPA) endorsed by AU Heads of State in 2005 and the Roadmap for Shared Responsibility and Global Solidarity for the AIDS, TB and Malaria response in Africa, endorsed by AU Heads of State in 2012. Both decisions focus on ensuring the sustainable supply of quality essential medicines to improve public health and promote industrial and economic development on the continent.

The AMRH works on the premise that the regulatory agencies of the African Union’s 55 member states currently operate independently with limited capacity, different regulatory requirements that have invariably resulted in the circulation of substandard and falsified medicines in most African markets. In addition, the different regulatory environment in each country is a technical barrier to pharmaceutical trade between countries and across regions in Africa.