Implementing the African Union Model Law at the Regional and National level
Model Law on Medical Products Regulation by AU Heads of State and government in January 2016, the next strides involve engaging with regional economic communities (RECs), regional organisations (ROs), and member states in updating and enacting regional legal frameworks and national laws. The Model Law was endorsed by the AU as a reference guide for member states as they update or enact national laws on medical product regulation.
In order for the implementation of the AU Model Law to succeed, RECs, ROs, and member states must conduct preliminary needs assessments of the existing medicines regulatory legal framework and system in individual countries, using the Model Law as a benchmark. A roadmap must then be developed to clearly stipulate the plan of action to be undertaken based on identified gaps.