Johannesburg, May 3, 2019
The African Union Development Agency-NEPAD African Medicines Regulatory Harmonisation strategic plan (2018-2023) has set a target to have 25 countries domesticate the African Union Model Law by 2020. Developed in response to prevailing gaps in national legal frameworks for the regulation of medical products, the Model Law has continued to serve as a reference guide to African countries in enacting and/or reviewing national medicines legislations. It has also served as a guide to Regional Economic Communities in the implementation of their Medicines
Regulatory Harmonisation Projects.
AUDA-NEPAD organised the first in a series of regional training workshops on the African Union Model Law on Medical Products Regulation from 1 to 3 May, in Johannesburg, South Africa. The training workshop aimed at equipping legal and regulatory experts from AU Member States with the necessary skills to effectively implement the domestication of the AU Model Law in their respective countries.
The AU Model Law was developed through a partnership between the Africa Union Commission, AUDA-NEPAD, the Pan-African Parliament and other partners to serve as a guide to AU Member States and Regional Economic Communities in the strengthening and harmonisation of medical products regulatory systems. It was endorsed by the AU Assembly of Heads of State and Government in January 2016.
The AU Model Law is a key component of the African Medicines Regulatory Harmonisation initiative, which was established in 2009 as a platform to strengthen regulatory capacity through harmonisation and collaboration with national medicines regulatory agencies and their respective regional economic communities.
The main objectives of this three-day regional training workshop on the AU model law domestication were to:
- Discuss and exchange information on the AU Model Law domestication process, including verification of the findings of the AUDA-NEPAD survey on the domestication process and the technical assistance needs of AU Member States;
- Provide training on the legal and regulatory issues related to the domestication process of the AU Model Law into national laws; and
- Consult with participating member states on the development of guidance documents that can be used as training materials for future workshops to facilitate the domestication process.
In organising this workshop, AUDA-NEPAD partnered with the United Nations Development Programme through its Access and Delivery Partnership (ADP). The ADP is a global project which aims at supporting countries to reinforce their health systems through strengthened policies, human capacities, systems and regulations needed to ensure that medicines, vaccines and diagnostics ultimately reach the people who need them.
These collective efforts of the AUDA-NEPAD and UNDP are in line with the priorities of the AU as set out in “Agenda 2063: The Africa We Want”, the African continent’s strategic framework to deliver inclusive and sustainable development, as well as the 2030 Agenda for Sustainable Development adopted by the United Nations Member States.