African Heads of State and Ministers for Health have long been concerned about the effective regulation of medical products on the  continent. This arose out of the commitment of Member States of the African Union (AU) to “protect the health of their people towards the  attainment of the highest possible physical and mental wellbeing of all”1 through the regulation of medical products and adequate mechanisms for guaranteeing their quality, safety and efficacy. Another reason for the need of regulation relates to the concern  about the proliferation of substandard and falsified (SF) products, which pose a major health threat across the continent. One critical  measure is to help countries strengthen their regulatory capacity through the mechanism of the African Union Model Law on Medical Products Regulation (Model Law); another is the treaty for the establishment of the African Medicines Agency (AMA).

The AU Model Law process began in early 2014 with the development of a zero draft, on which comment was invited from a range of  stakeholders and experts. Subsequently, a first draft was presented at regional stakeholder consultations within the AU regions during the period from 2014 to 2015. The draft was then amended after inputs received at the regional meetings. Next, the draft incorporating the  feedback from the regions was submitted through the governance structures of the AU, and the final version of the AU Model Law was  officially adopted by African Heads of State and Government at the AU Summit in January 2016, in Addis Ababa, Ethiopia. The AU Model  Law provides a template for countries to harmonize their regulatory frameworks and outlines the key functions and standards that should  form part of the regulatory system. These provisions will be discussed in greater detail below.

The AU is now supporting Member States in domesticating the AU Model Law into their national legislation. The African Union Development  Agency (AUDA-NEPAD) is coordinating capacity-building and providing technical assistance to enable countries to review  their legislation in place on medical products regulation and effect the requisite amendments in order to align them with the AU Model Law.  The respective Regional Economic Communities (RECs) are actively involved in facilitating this process.

This guidance document aims to assist countries as they navigate through the domestication process. It provides material on understanding  key concepts, guidance on how to draft legislation and a chapter-by-chapter analysis of the AU Model Law, explaining the  meaning of each provision and the reason for its inclusion. It also offers useful drafting suggestions. All of these features will enable  countries to align their regulatory laws to the AU Model Law and will not only facilitate effective regulation in each country but will also  advance the goal of the harmonization of regulatory systems.