To play a leading role in the scientific evaluation of human medicinal products at continental level and in harmonizing assessment, registration and marketing authorization activities at REC and NRA levels.To play a leading role in the scientific evaluation of human medicinal products at continental level and in harmonizing assessment, registration and marketing authorization activities at REC and NRA levels.

To protect Africa’s public health through ensuring that medicines including vaccines circulating on African markets are of acceptable quality, safety and efficacy.

Established to assist AU Member States, RECs MRH programs and AMA once operational in the scientific evaluation of human medicinal products at continental level and in harmonizing assessment, registration and marketing authorization activities at REC and NRA levels.

Work with AU member states through RECs MRH programs and respective NRAs to develop or establish and enforce requirements for quality, safety and efficacy of medicinal products circulating in African markets.

1. Develop documents, technical requirements, and guidelines to support assessment activities at continental, regional and national levels and guide manufacturers
2. Adapt the Common Technical Document (CTD) format proposed by ICH for application for registration of priority human medicines in Africa in line with internationally acceptable standards (such as WHO standards) and promote use of electronic format.
3. Develop harmonized technical requirements and guidelines for issuing scientific opinions and recommendations for registration of medicines.
4. Develop harmonized technical requirements and guidelines that could be used in an emergency situation and ultimately Emergency Use Authorization (EUA) of human medicines at NRA level
5. Develop standard operating procedures (SOPs) and standardized templates for joint assessment of applications for registration of priority medicines at continental and regional level.
6. Support the harmonization and alignment of guidelines and procedures already used for joint assessments done at RECs level 
7. Facilitate domestication of the agreed technical documents for registration of medicines including guidelines, and SOPs for assessment of application dossiers.
8. Contribute to the development of international guidelines
9. Identify and develop a list of priority medicinal products that will be jointly assessed at continental level due to African health priorities, their complexity or the necessary expertise required to assess them.
10. Identify and approve a list of experts that will support the work done by the EMP-TC
11. Develop continental medicinal product evaluation processes in line with the quality management system (QMS) in place at AMRH and/or AMA to support registration by countries and devise a mechanism for submission of applications for continental assessment
12. Organize the assessment of applications for the list of priority medicinal products assessed at continental level and provide final scientific recommendations on medicinal products (positive or negative), based on assessment reports, and share them with NRAs to support registration and marketing authorizations.
13. Establish and maintain an information management system to facilitate sharing of information among members and keeping track of all activities done and documents produced by the committee.
14. Develop a communication plan to ensure NRA’s appropriation and implementation of recommendations at country level.
15. Liaise with Joint AMRH Secretariat to monitor the implementation of EMP TC’s recommendations in supporting the national decision in the issuance of marketing authorizations in countries
16. Organize follow-up assessments of changes (variations or extensions) for medicine applications assessed at continental level.
17. Assess needs and contribute to the development of a continuous and sustainable training program for NRAs assessors in close collaboration with TC on Regulatory Capacity Development (RCD-TC) and the Regional Centers of Regulatory Excellences (RCOREs).
18. Promote the use of reliance models at continental, regional and NRA levels including the WHO collaborative registration procedures for WHO PQ medicines and vaccines and medicinal products approved by SRA /WLA  or the AMA recommendations to facilitate approval of medicinal products but also for information/experience sharing and capacity building.
19. Provide scientific advice and guidance to manufacturers applying for priority medicinal products assessed at continental level
20. Collaborate closely with other AMRH TCs (GMP TC, RCD TC, IMS TC, AMQF TC, AVAREF…) to facilitate decision making process by the appropriate AMRH and/or AMA Governance structures, when operational.
21. Cooperate with international partners on the harmonization of regulatory requirements for registration and for scientific guidance, when needed.
22. Submit progress report on the implementation of its plan of action to the AMRH Steering Committee.