The AMRH was launched in 2009 with the aim of helping African countries to set up an effective system for the registration of medicines, thanks to regional harmonisation and capacity building. Likewise, the AMRH tried to improve the fragmented regulating system for the registration of products in Africa by moving from a country-centred approach to a collaborative, simplified, regional one.
Here are a few details relevant to this initiative:
- the initial baseline assessment which indicates the variation in national laws and regulations, the absence of a mutually recognized legal framework, significant differences in capacity among regulatory authorities, differences in legal frameworks between countries and inconsistency between regulatory frameworks and procedures in ethical research committees;
- progress in harmonizing registration requirements and joint assessments in the ethics committees of the different sub-regions. It should be noted that the overall coverage of the AMRH initiative across the continent is greater than 85%;
- the state of implementation of the African Union Model Law on Regulation of Medical Products which aims to ensure effective regulation and promote harmonization and which is at different levels of domestication and enforcement; implemented in twelve African countries, namely Burkina Faso, Seychelles, Zimbabwe, Lesotho, Namibia, Swaziland, the Gambia, the United Republic of Tanzania (Zanzibar), the Republic of Rwanda, the Republic of Burundi and the Republic of Mozambique.
- efforts to combat substandard and falsified medical products;
- the establishment of Regional Centres of Regulatory Excellence to develop and strengthen the regulatory capacity in Africa; there are eleven at the moment;
- – the establishment of biennial scientific conferences on the regulation of medical products in Africa, a continental platform for sharing lessons learned and best practices, facilitating networking and collaboration, reflecting on work to date and rejuvenating actions to maintain regulatory momentum;
- strengthening and harmonization in Africa; in 2017, the theme of the conference in Accra (Ghana) was: ‘Maintaining Momentum for Regulatory Harmonization in Africa’;
- finally, aligning efforts to strengthen and harmonize regulatory systems as the foundation of AMA, the African Medicines Agency.
Ref: Ndomondo-Sigonda M. et al. The African Medicines Regulatory Harmonization Initiative: Progress to Date. Medical Research Archives 2018; 6(2): 1-15 with summary by R. Ravinetto.