Under the African Medicines Regulatory Harmonization (AMRH) Initiative, several Technical Committees (TCs) have been put in place to spearhead regulatory systems strengthening and harmonization in Africa working with Regional Economic Communities (RECs) medicines harmonization initiatives and National Regulatory Authorities (NRAs). These continental technical committees are working to support the AU in the operationalization of the African Medicines Agency (AMA) and among other, the TCs shall be responsible for conducting scientific assessments and to providing scientific opinions on the safety, efficacy, and quality of priority medical products.

Specifically, the Evaluation of Medicinal Products Technical Committee (EMP-TC) established by the AMRH Steering Committee plays a vital 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.

A priority area for AMRH is harmonization of requirements for the registration of generic[1] products, which rely heavily on the use of bioequivalence (BE) studies, a subset of bioavailability (BA) studies, to support the products safety and efficacy. For this reason, the EMP-TC formed the BA/BE continental technical working group (TWG) to focus on establishing harmonized requirements for BA/BE studies to support the approval of generic medicinal products.

In this respect, the AMRH Secretariat invites Expression of Interests (EoIs) from experts in BA/BE assessments, inspections and research to be members of the continental TWG for harmonization of BA/BE requirements.

The scope of assignment for the working group members shall be to harmonize BE requirements based on internationally accepted standards for adoption by countries across Africa and categorize complex and priority products that are best reviewed at the level of NRAs, RECs, or AMA. Further details and specifics are outlined in the attached terms of reference.

The desired qualification and experience for assessors are as follows:

• A minimum of 5 years of experience in matters related to BA/BE studies including assessment, research, GCP inspections, etc.
• Experience assessing BA/BE studies or associated comparative studies for complex products (i.e. topical products, drug-device combinations, suppositories, etc.) will be an added advantage
• Experience as an assessor for the WHO Prequalification program for medicines or involvement with development of guidelines with the ICH or WHO will be an added advantage.

Interested applicants with the required competencies should submit the following:

• A cover letter expressing interest, addressed to the AMRH EMP TC Secretariat, stating their areas of expertise and progressive experience specifically in the area of bioavailability or bioequivalence studies including the types of products, the types of studies (i.e. in vivo and/or in vitro studies), and the components (i.e., clinical, analytical, and/or statistical).
• A detailed CV indicating relevant experiences as described above. The CV should not be more than 5 pages long and should be reflective of area applied for.
• Interested and potential candidates who wish to be provided with clarifications on this matter may contact the AMRH Secretariat (amrh@nepad.org).
• Expression of interest documents should be submitted electronically through the e-mail address: amrh@nepad.org with the subject titled “EXPRESSION OF INTEREST TO BE CONSIDERED AS A MEMBER OF THE EMP-TC TWG ON BA/BE”.

The deadline for submission is 30 April 2024 at 14:00 South-African time. Late submission of Expression of Interest shall not be accepted for evaluation irrespective of circumstances.

[1] A generic product, as defined by the WHO, is a pharmaceutical equivalent or pharmaceutical alternative product that may or may not be therapeutically equivalent to a comparator product. Products that are therapeutically equivalent are interchangeable.