AUDA NEPAD

REQUEST FOR EXPRESSIONS OF INTEREST (REOI)

Procurement Title: Consultancy Services To Support the African Medicines Regulatory
Harmonization – Good Manufacturing Practices (AMRH GMP) Coordination for Operationalization of the Africa Medicines Agency (AMA)
Procurement Number: 481/AUDA/DHCID/HC/ICS/2026
Method: Individual Consultant Selection (ICS)
1. Background
The African Medicines Regulatory Harmonization (AMRH) initiative is a program under the African Union Development Agency – New Partnership for Africa’s Development (AUDA-NEPAD) playing a pivotal role in the support to the establishment of the African Medicines Agency (AMA), which aims to provide a continental regulatory framework for medicines and other medical products in Africa.

The operationalization of AMA has commenced, including the continental pilot listing of biological products, including vaccines. This initiative integrates Good Manufacturing Practice (GMP) inspection and clearance to ensure that only high-quality, safe, and effective vaccines reach African populations. AMRH, in collaboration with national regulatory authorities (NRAs) and regional economic communities (RECs), is committed to strengthening vaccine regulatory oversight through capacity development, regulatory convergence, and local production promotion.

To further support these efforts, AUDA-NEPAD is seeking an individual consultant with expertise in vaccine regulatory oversight, GMP certification, and regulatory systems strengthening to contribute to AMRH’s objectives.
2. Objectives of the Assignment
The primary objective of this consultancy is to provide technical support to AMRH in strengthening vaccine regulatory oversight in Africa through the support to the Good Manufacturing Practice

Technical Committee (GMP-TC).
3. Main Responsibilities
The scope of work to be undertaken will include the following:
i. Report on GMP Certification Schemes for Vaccine Manufacturing in Africa Contextualize available global and continental GMP playbook to African GMP inspection frameworks, clearance models, certification schemes, and proposed harmonised continental approaches to vaccines manufacturers listing

ii. Structured Training and Capacity Development Plan for Vaccine Regulatory Experts Support the coordination of at least 2 mock inspections and competency-based regional training including modules, and training pathways for NRAs and technical committees’members.
iii. Continental Framework for the Listing of Vaccines Under AMA/AMRH Mechanisms Revise the existing technical framework for the continental listing of vaccines covering submission requirements for GMP inspections and post-listing obligations.
iv. Strategy Document on Preventing, Detecting, and Responding to Substandard and Falsified (SF) Vaccines provide GMP and inspections inputs to the existing AUDA-NEPAD continental strategy on SF.
v. Guidance Document for Strengthening National Regulatory Authorities (NRAs) in Vaccine Regulatory Oversight Develop a procedure on implementation of GMP oversight and Reliance on GMP inspections based on the continental overarching procedure
vi. Roadmap for Advancing Local Vaccine Production in Africa
Validate through GMP-TC and mock inspections a milestone-based roadmap defining strategic interventions, enabling regulatory and policy reforms, GMP readiness benchmarks, investment requirements, partnership models, and harmonised pathways to support domestic vaccine manufacturing.
4. Deliverables
The consultant will be expected to submit the following deliverables:
i. A comprehensive report on GMP clearance and certification schemes for vaccine manufacturing.
ii. Updated and structured training and capacity development plan for GMP inspectors
iii. A revised framework for the continental listing of vaccines.
iv. A GMP-strategy document with an improved section on addressing substandard and falsified vaccines.
v. A guidance document on strengthening NRAs in vaccine regulatory oversight.
vi. A roadmap for promoting local vaccine production in Africa from a regulatory point of view.
vii. Final Technical Report
5. Qualifications and Experience Requirements
Applications may be submitted by an-Expert with the qualifications and experience stipulated below:
i. Applicant must have a Bachelor’s degree in pharmacy, medicine, chemistry, biochemistry or any other related field. Applicant must also have a Master’s degree in pharmacy, medicine, public policy, governance, regulatory affairs or any other related field.
ii. At least 10 cumulative years of experience in pharmaceutical/ vaccine manufacturing industry plus regional pharmaceutical/ vaccines regulation in Africa.
iii. A candidate with experience working in a national medical products regulatory body, Regional Economic Community Medicines Harmonization programme or international harmonization initiative OR relevant is highly preferred.
iv. Experience with the AMRH Initiative at continental level. professional with exposure to regional, continental and international collaboration.
v. Experience with regulatory capacity development in Africa
vi. Experience with promotion of local production of pharmaceuticals/ vaccines in Africa. Experience with successful new greenfield pharmaceutical projects in Africa would be a distinct advantage
6. Evaluation Criteria
A consultant will be selected in accordance with the individual consultant selection method of the
AU Procurement manual. For evaluation of the expressions of interest, the following criteria will be applied:
a. Qualifications - Education and Relevant Training (20 points);
b. Relevant Experience (55 points);
c. Knowledge and experience of Africa and continental contexts (20 points).)
d. Preference margin for AU member state citizens, youth and women (5 points)
e. The minimum qualifying score is 70 points The detailed Terms of Reference (TOR) for the assignment can be found at the following website: (https://www.nepad.org/corporate-procurement#tenders).

7. Submission Requirements

AUDA-NEPAD now invites eligible individual consultants (“Consultants”) to indicate their interest in providing the Services. Interested consultants should provide information demonstrating that they have the required qualifications and relevant experience to perform the Services. Interested candidates are requested to submit the following documents for AUDA-NEPAD consideration:
i. Cover letter confirming compliance to eligibility.
ii. Signed declaration of undertaking (attached as Annex 1 below);
iii. Curriculum Vitae (CV); and
iv. Proof of stated qualifications in the form of the copies of the degrees obtained.

Only Individual Consultants are eligible for this assignment and they must fulfil the following eligibility criteria:

i. Have no conflict of interest in relationship to performance of this assignment;
ii. Are not subject to and not controlled by any entity or individual that is subject to, a temporary suspension or a debarment imposed by the African Union Commission, World Bank or any other multilateral development bank and being listed on the website http://www.worldbank.org/debarr or respectively on the relevant list of any other multilateral development bank. Further, are not ineligible pursuant to a decision of the United Nations Security Council.
iii. Have not been convicted by a final judgement or a final administrative decision or subject to financial sanctions by the United Nations or Country for involvement in a criminal organisation, money laundering, terrorist-related offences, child labour or trafficking in human beings; this criterion of exclusion is also applicable to legal Persons, whose majority of shares are held or factually controlled by natural or legal Persons which themselves are subject to such convictions or sanctions;

iv. Are not being bankrupt, wound up or ceasing our activities, having our activities administered by courts, having entered receivership, reorganisation or being in any analogous situation;
v. Are not involved in corruption: offering, giving, receiving or soliciting, directly or indirectly, anything of value to influence improperly the actions of another party;
vi. They have not been the subject of a judgment which has the force of res judicata for fraud, corruption, involvement in a criminal organization or any other illegal activity detrimental to the AUDA-NEPAD financial interests;
vii. they have not been declared guilty of gross professional misconduct proven by any means which AUDA-NEPAD can justify;
viii. Comply with their national tax and social security laws

8. Expressions of interest must be delivered to the address below by email on or before 12th January 2026 at 14:30 hours (South African Time) with the following title in the subject line of the email:

481/AUDA/DHCID/HC/ICS/2026, Consultancy Services To Support the African Medicines Regulatory Harmonisation – Good Manufacturing Practices (AMRH GMP) Coordination for Operationalization of the Africa Medicines Agency (AMA)

The Chairperson, Internal Procurement Committee (IPC)
African Union Development Agency (AUDA-NEPAD)
P. O. Box 218 Midrand,1685 Johannesburg, South Africa
Email: [email protected] ; and copy to [email protected]