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EXTENSION: Continental Pilot for Listing of Human Medicinal Products by the Evaluation of Medicinal Products Technical Committee (EMP-TC)
EXTENSION OF WINDOW FOR SUBMISSION OF EXPRESSION OF INTERESTS (EOIS)
Introduction
On the 1st of November 2023, the AUDA-NEPAD through the AMRH initiative announced the launch of the pilot of the continental procedure on evaluation of medicinal products led by its Evaluation of Medicinal Products Technical Committee (EMP-TC) supported by the Good Manufacturing Practices Technical Committee (GMP-TC). This pilot is one of the core interventions by the AUDA NEPAD in supporting the technical operationalisation of the African Medicines Agency (AMA) which aims to build on regional harmonization initiatives to strengthen regulatory systems continent-wideand facilitate regulatory reliance in alignment with internationally acceptable standards.
Following requests from various industry stakeholders, we are thrilled to announce an extension of the window for submission of expressions of interest to participate in our pilot program for listing human medicinal products. This is your chance to showcase your innovative products and make a difference in the world of healthcare.
Timelines
Key timelines for this extension are provided below:
Window opened for submission of Interests (EOIs) - 8 April 2024
Window closed for industry to submit EOIs - 10 May 2024
Window opened for submission of dossiers - To be communicated to successful applicants
More details on how to submit EOIs is as provided in the previous call accessed here:
Contacts
For all technical related matters contact: amrh@nepad.org copy to: emp@nepad.org
For general enquiries and submissions communication: AUDAPilot@sahpra.org.za
Request for expressions of interest for selection of members for the Bioavailability/Bioequivalence Technical Working Group under the Evaluation of Medicinal Products Technical Committee.
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.
Call for applications to deploy Independent Evaluation Group members for the African union Peace Fund
March 8 to May 9, 2024
In operationalising its last Governance Body, the Independent Evaluation Group, the African Union Peace Fund is inviting qualified experts to apply to this call for applications by submitting their CVs as well as other academic credentials.
Please find attached the Terms of Reference. The deadline for submission of online applications is midnight (EAT) 9 May 2024.
All applications will go through AUC shortlisting and selection process, through the Panel of Eminent Persons, which could lead to the appointment to be a Member of the AU Peace Fund Independent Evaluation Group, thereby enabling Peace Fund Secretariat to deploy successful experts as and when their services are required.
Call for applications to deploy Independent Evaluation Group members for the African union Peace Fund
March 8 to May 9, 2024
In operationalising its last Governance Body, the Independent Evaluation Group, the African Union Peace Fund is inviting qualified experts to apply to this call for applications by submitting their CVs as well as other academic credentials.
Please find attached the Terms of Reference. The deadline for submission of online applications is midnight (EAT) 9 May 2024.
All applications will go through AUC shortlisting and selection process, through the Panel of Eminent Persons, which could lead to the appointment to be a Member of the AU Peace Fund Independent Evaluation Group, thereby enabling Peace Fund Secretariat to deploy successful experts as and when their services are required.
Download the NEPAD Consolidated Procurement Plan for more information.
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Tel: +27(0) 11 256 3600
Email: procurement@nepad.org