A
AUDA-NEPAD
AFRICAN UNION DEVELOPMENT AGENCY
Consultancy Services to Support Operationalization of the Network of African Reliance Laboratories (NARL)
PROCUREMENT NUMBER: 52/AUDA/HCID/ID/ICS/2024
Method: Individual Consultants Selection (ICS) - Individuals Only
1. INTRODUCTION
African National Quality Control Laboratories (NQCLs) have over the last decade made significant advances in the quality control (QC) of small molecule drugs. However there still remains a significant capacity gap in bio-analytical testing of large molecule drugs (biologicals) including vaccines comparable with international best practices. As the continent steps up efforts for local manufacturing of vaccines with the announcement of new vaccine manufacturing initiatives by 17 African countries, their national regulatory authorities (NRAs) and associated NCLs would need support to build capacity for vaccine regulatory oversight.
Lot release (LR) is a regulatory function specific to biological products, such as vaccines, with the purpose of ensuring a product's quality in comparison with defined specifications through a system of regulatory release. A component of LR may include independent quality control (QC) testing of the product. QC testing can also be a requirement for product registration, investigations of adverse events, vigilance (checking and confirming the quality of products placed on the market), and for detecting substandard and falsified medical products.
To advance regulatory harmonisation and operationalisation of the African Medicines Agency (AMA), there is a need to build African regulatory systems in general, and laboratory capacity, specifically. The development and operationalization of a Network of African Reliance Laboratories (NARL) one of the identified priorities for the African Medicines Regulatory Harmonisation (AMRH) in support of AMA operationalisation.
2. SCOPE/MAIN RESPONSIBILITIES OF THE ASSIGNMENT
The Consultant shall work with the AUDA-NEPAD AMRH Secretariat to deliver on the following tasks:
a. Develop and administer an Expression of Interest (EOI) among African NQCLs to facilitate the membership within the various categories of the ANCL-RN (full members, associate members and observers).
b. Define the Central Coordination Unit (CCU) of the NARL in alignment with the AMRH governance structure within the AUDA-NEPAD and AMRH Secretariat including recommendation on competencies, job description, reporting channel and job description of CCU staff.
c. Facilitate the launch of NARL during AMRH governance meetings.
d. Guide NARL in development and domestication of harmonized guidelines, regulatory frameworks, standards and tools.
e. Support the CCU to facilitate the first annual meeting of the NARL to constitute the Assembly of Member, the Steering Committee and initial working groups.
f. Establish outreach programs of NARL, monitor and report progress and impact.
g. Establish peer review mechanisms for processes and conduct mock audit programs for the NARL.
h. Develop a comprehensive roadmap to address capacity gaps in facilities, equipment's and supplies, personnel, trainings and emergence preparedness
- DELIVERABLES
The deliverables of the consultant shall include:
a. Central Coordination Unit (CCU) designed, governance and reporting system defined b. Outreach programs for ANCL-RN established and bi-annual reporting mechanism instituted c. Roadmap for reliance laboratories developed in alignment with the continental regulatory reliance framework.