The South African Health Products Regulatory Authority (SAHPRA) hereby invite expression of interest for candidates to serve as External Evaluators for CEO Technical Advisory Committees. SAHPRA is a Schedule 3A Public Entity established in terms of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965) to oversee the regulation of medicines, medical devices, and in vitro diagnostics (IVDs) intended for human and animal use; the licensing of manufacturers, wholesalers and distributors of medicines, medical devices and IVDs; and the conduct of clinical trials.
How to apply
- A comprehensive CV, qualification/s and a motivation expressing area of expertise must be submitted online at https://apply.sahpra.org.za:6006/
- For detailed requirements, please read here.
- Only documents in pdf must be uploaded.
- Further communication will be limited to nominated candidates with appropriate skill sets.
- Closing date for nominations is Friday, 15 December 2023 at 16:30. No late nominations will be accepted.
African Union Development Agency (AUDA-NEPAD) through the African Medicines Regulatory Harmonisation (AMRH) initiative is announcing the launch of a phase 1 of the pilot of the continental procedure on evaluation of medicinal products through its Evaluation of Medicinal Products.
Technical Committee (EMP-TC) supported by the continental technical committee on Good Manufacturing Practices (GMP-TC).
In accordance with the AU Executive Council Decision, {EX.CL/Dec.857 (XXVI))} of January 2015, the African Medicines Regulatory Harmonisation (AMRH) initiative is a foundation for AMA. Therefore, the pilot of the evaluation of medicinal products continental procedure is launched in support of the operationalisation of the African Medicines Agency (AMA).
How to submit?
Medicinal Product Dossier should be submitted as per the current SAHPRA submission procedure and compiled in accordance with the EMP TC Guidelines on Submission of Application for Listing of Medicinal Products. The EMP TC specific guidelines for medicines, vaccines, bio therapeutic products and similar biotherapeutic products can be accessed: https://amrh.nepad.org/amrh-resources.
For a more detailed submission guidance and application forms and letter template. Please refer to the EMP TC Procedural Aspect Guidelines During Pilot. The Guidelines can be accessed: https://amrh.nepad.org/amrh-resources.