The African Medicines Regulatory Harmonisation (AMRH) Initiative was established in 2009 as an African Union (AU) Programme to support the implementation of the Pharmaceutical Manufacturing Plan for Africa (PMPA) under the New Partnership for Africa’s Development (NEPAD) Framework. The AMRH Initiative aims to address the disparate regulatory systems on the continent working through regional economic communities (RECs).
The development, adoption by the AU Assembly and subsequent coming into force of the Treaty for the establishment of the AMA is a result of the foundation built by the AMRH Initiative as part of the PMPA framework[1]. The creation of AMA is the final component of the AU vision of a strengthened medicines regulatory ecosystem on the continent, which, among others, will play a critical role in support of the AU plan to advance vaccines manufacturing.
Under AMRH, several Technical Committees have been put in place. These committees will also be necessary for the AMA as described in the AMA Treaty[2] . They could become the TCs for AMA when fully established and will be responsible for conducting scientific assessments and providing scientific opinions.
The Evaluation of Medicinal Products Technical Committee (EMP-TC) established by the AMRH Steering Committee (and which may be transferred under AMA) plays a vital role in the scientific evaluation of human medicinal products at continental level and harmonising assessment, registration and marketing authorisation activities at REC and NRA levels.
Among its specific objectives, this committee is to develop continental medicinal product evaluation processes to support registration by countries and devise a mechanism for submission of applications for continental assessment for priority products. It is also expected to organise the assessment of applications for the list of priority medicinal products assessed at continental level, provide final scientific recommendations on medicinal products (positive or negative) based on assessment reports, and share them with NRAs to support registration and marketing authorisations.
This procedure describes the process proposed to undertake a comprehensive evaluation of the quality, safety, and efficacy of medicinal priority products based on information submitted by the applicants of such products (manufacturers or suppliers) and on an inspection of the corresponding manufacturing facilities and clinical sites. This will be done through a standardised procedure based on quality standards applicable for continental evaluation. These standards will be mainly based on WHO standards and, if not existing, ICH standards or any other relevant standards until customised African standards are developed and adopted.
This guideline has been developed after a review of the WHO Prequalification Procedure WHO TRS N°961 untitled (who.int), 2011 and the European Medicine Agency (EMA) centralised procedure Marketing authorisation | European Medicines Agency (europa.eu). Flowcharts and Procedures used for joint assessments and inspections of medicinal products by Regional Economic Communities have also been reviewed (in particular, EAC, ECOWAS and ZAZIBONA/SADC).
When operating under the AMRH or when the AMA is fully operational under the current AMA Treaty, the medicinal products found to meet AMRH standards after evaluation by the EMP-TC will be included in the list of medicines recommended by AMRH/AMA and published on the website to facilitate reliance and pooled procurement through the AU. However, EMP-TC recommendations do not imply any approval of products/manufacturing sites by AMRH/AMA, which is the only prerogative of NRAs of concerned member states.
African countries can decide to adopt EMP-TC recommendations for granting a national marketing authorisation through a reliance mechanism after accessing the product assessment and inspection reports produced by the EMP-TC.
In addition, as a specialised agency of the African Union, AMA is expected to also play a role in the global space in alignment with AU agenda 2063 by establishing a pathway for evaluating and publishing its scientific opinion on medicinal products for human use when manufacturers, sponsors or applicants intend to use the AMA opinion in applying for marketing authorisation of any product even if the intended market is not Africa.
[1] AU Executive Council Decision, {EX.CL/Dec.857 (XXVI))} of January 2015