AUDA-NEPAD

REQUEST FOR EXPRESSIONS OF INTEREST (REOI)
Procurement Title: Consultancy Services to Support The ‘Agence Ivoirienne De
Reglementation Pharmaceutique’’ AIRP (Côte d'Ivoire), In Developing a Reliance Framework
and Strengthening the National Regulatory System Function in Line with WHO GBT
Requirements
Procurement Number: 060/AUDA/DHCID/AMRH/ICS/2025
Method: Individual Consultant Selection (ICS)
1. Background
The African Union Development Agency (AUDA-NEPAD) is the technical body of the African
Union whose mandate is to coordinate and execute priority regional and continental projects to
promote regional integration towards the accelerated realization of Agenda 2063 and strengthen
the capacity of Member States and regional bodies, including Regional Economic Communities
(RECs).
The African Medicines Regulatory Harmonisation (AMRH) Initiative was launched in 2009 to
support African Union’s efforts on ensuring access to quality-assured, safe and effective medical
products. The AMRH directly support’s the African Union’s efforts of promoting local
manufacturing of medical products as outlined in the Pharmaceutical Manufacturing Plan for
Africa (PMPA) and Platform for Harmonized African Health Products Manufacturing (PHAHM).
The Initiative works with National Regulatory Authorities (NRAs) to support development and
implementation of standards, guidelines, and processes for regulating medical products across
the continent.
Through the AMRH, the AUDA-NEPAD support’s Member States of the AU to adopt up-to-date
laws and regulations as a foundation for a robust national regulatory system for medical products
and harmonised regulatory systems across the continent. In this context, AUDA-NEPAD is
supporting the Republic of Côte d'Ivoire through the ‘Agence Ivoirienne de Reglementation
Pharmaceutique’’ (AIRP) to review and update their national regulatory systems for medical
products to comply with the AU Model Law on medical products regulation (Model Law) and
WHO's Global Benchmarking Tool (GBT).
2. Objectives of the Assignment
The main objective of the consulting services is to support the AIRP to develop a Reliance
Framework and strengthen the National Regulatory System in line with WHO GBT Requirements.

3. Main Responsibilities
In undertaking this exercise, the consultant will be expected to frequently consult and interact
with the designated officer in AIRP. The scope of work to be undertaken will include the
following:
i. Conduct a comprehensive desk review of existing regulatory reliance pathways
implemented by AIRP across all regulatory functions for medicines, vaccines and medical
devices including diagnostics in accordance with GRelP.
ii. Work with the AMRH initiative in the process of localizing the continental reliance framework
to AIRP.
iii. Review the recommendations from the pre-benchmarking assessment related to the
function of the National Regulatory System.
iv. Develop a National Reliance Framework for all regulatory functions that will promote a more
efficient approach to regulation of medical products as per WHO Global Benchmarking Tool
(GBT) plus for medicines, vaccines and medical devices including in vitro diagnostics with
practical guides, illustrative examples of reliance approaches and their implementation.
v. Work closely with the WHO GBT focal point within AIRP to meet the requirements related
to national regulatory system.
vi. Assist in identifying and domesticating the required guidelines and relevant texts in line with
the recommendation from the pre-benchmarking assessment.
vii. Facilitate stakeholder consultations to validate the Reliance Framework and other texts
developed to meet the recommendations for the National Regulatory System function.
4. Deliverables
The consultant will be expected to submit the following deliverables:
i. Project inception report
ii. Report on the review of existing regulatory reliance pathways implemented by AIRP and
recommendations from the pre-benchmarking assessment related to the function of the
National Regulatory System.
iii. Draft National Reliance Policy and associated guidelines
iv. Interim Report on the implementation of recommendations from the pre-benchmarking
assessment related to the function of the National Regulatory System
v. Final report on the implementation of recommendations from the pre-benchmarking
assessment related to the function of the National Regulatory System
vi. Final National Regulatory Reliance Policy and associated guidelines
5. Qualifications and Experience Requirements
Applications may be submitted by a French-Speaking-Expert with the qualifications and
experience stipulated below:
i. Master’s degree in medical regulatory science, pharmacy, medicine, chemistry, medical
laboratory sciences, biomedical engineer, or any other related field.
ii. A minimum of 10 years work experience in implementation of regulatory reliance, networks
and convergence, regulatory systems strengthening or harmonization initiatives.
iii. Extensive experience in Quality Management Systems or in assisting National Regulatory
Authorities with the implementation of WHO GBT requirements.

iv. Experience working in a medical products regulatory body, Regional Medicines Regulatory
Harmonization programme or international harmonization initiatives will have an added
advantage.
v. Good knowledge on the African medical products regulation ecosystem, AMRH Initiative,
RECs MRH initiatives.
vi. Demonstrable exposure to international collaboration in the sector
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 (30 points);
b. Relevant Experience (50 points);
c. Knowledge and experience of the region & local conditions (10 points).)
d. Preference margin for AU member state citizens, youth and women (10 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
Expressions of interest must be delivered to the address below by email on or before 14th
November 2025 at 14:30 hours (South African Time) with the following title in the subject line
of the email:
“060/AUDA/DHCID/AMRH/ICS/2025, Consultancy Services to Support The ‘Agence
Ivoirienne De Reglementation Pharmaceutique’’ AIRP (Côte d'Ivoire), In Developing a
Reliance Framework and Strengthening the National Regulatory System Function in Line

with WHO GBT Requirements,”

The Chairperson, Internal Procurement Committee (IPC)
African Union Development Agency (AUDA-NEPAD)
230, 15th Road, P. O. Box 218 Midrand,
1685 Johannesburg, South Africa

Email: [email protected] ; and copy to [email protected]

Attention of: Procurement Division