1. About AMRH Programme

The African Medicines Regulatory Harmonisation (AMRH) Programme, coordinated by the AUDA-NEPAD aims to improve access to medicines through harmonisation of regulatory requirements to ensure quality, safe and efficacious medicines are available to African citizens. AMRH mission is to provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa.  It does this by promoting the harmonisation of medicines regulations among African countries through Regional Economic Communities (RECs) and National Medicines Regulatory Authorities (NMRAs).  AUDA-NEPAD and its AMRH Partners[1] are supporting RECs and their member states in reviewing their policies and putting in place legal frameworks for effective medicines regulation. AMRH Programme fulfils its mandate through increased use of harmonized policies and regulatory frameworks by member states, increased human and institutional capacity for regulation of medical products and technologies, and improved regulatory standards and practices through knowledge generation and sharing.

2. Partnership for African Vaccine Manufacturing (PAVM)

The African Union and African CDC have established a partnership with an ambitious target to reach the goal of 60% local vaccine production by 2040. A Framework for Action has been developed to address the key enablers of the vaccine manufacturing ecosystem through 8 bold programs. These include creating an African vaccines pooled procurement mechanism, establishing a vaccine manufacturing deal preparation and financing facility, establishing a vaccine technology transfer and IP enablement unit, embedding vaccines regulatory excellence in National Regulatory Authorities (NRAs) and Regional Centers of Regulatory Excellence (RCOREs) through African Medicines Regulatory Harmonization (AMRH) and African Medicines Agency (AMA), setting up vaccine R&D centres and a coordinating unit, forming regional capability and capacity centres, advocating for enabling trade policies for vaccines while having a body drive continental strategy delivery and oversight as reflected in Figure 1below.

Figure 1: PAVM Bold Programs

Source: Africa CDC, Progress on Implementing the Partnerships for Africa Vaccine Manufacturing, Stakeholder Engagement, Kigali Rwanda, 6-7 December 2021

Regulatory Strengthening is one of the distinct workstreams of the framework for action which involves embedding vaccines regulatory excellence in NRAs and RCOREs. This will be done through the AMRH initiative and eventually the AMA, once operational.

The regulatory workstream of the PAVM Framework is building on the existing AMRH governance structures to enable appropriate regulatory oversight of vaccine manufacturing while ensuring alignment and continuity. The Heads of NRAs in frontrunner vaccine manufacturing countries are a critical part of the process and constitute the regulatory workstream taskforce to ensure effective coordination of partners’ efforts. The first implementation kick-off meeting of the PAVM Regulatory Workstream Taskforce was convened on 23 March 2022 to deliberate on implementation arrangements and plans.

Coordinating this work with ongoing work of AMRH and the establishment of AMA is essential given that there is considerable overlap in these different work areas. Taking this work forward will require partners support in the form of technical, financial and advocacy. The AMRH Partnership Platform and the World Health Organisation’s (WHO’s) Coalition of Interested Parties (CIP) will be leveraged to provide support.

3. Rationale for Regional Centres of Regulatory Excellence (RCOREs)

1. As part of its mandate to strengthen regulatory capacity development, the AMRH Programme has designated 11 Regional Centres of Regulatory Excellence (RCOREs).
2. RCOREs are institutions or partnership of institutions with specific regulatory science expertise as well as training capabilities.
3. RCOREs have a mission to produce regulatory workforce in Africa through:
   • Provision of academic and technical training in regulatory science applicable to different regulatory functions and managerial aspects.
   • Skills enhancement through hands-on training, twinning and exchange programmes among NMRAs.
   • Practical training through placement in pharmaceutical industry.

4. Categories of RCOREs

• The 11 designated RCOREs were categorized based on the then WHO Assessment Tool for national regulatory systems. They include:
  • Product evaluation and registration.
  • Clinical trials oversight.
  • Licensing of the manufacture, import, export, distribution, promotion and advertising of medicines.
  • Pharmacovigilance and Pharmacoepidemiology.
  • Inspecting and surveillance of manufacturers, importers, wholesalers and dispensers of medicines.
  • Providing independent information on medicines to professionals and the public.
  • Quality Assurance and Quality Control of medicines and medical devices.

• Given the new developments, the new RCOREs will be categorised according to their areas of expertise and strength in training and/or service delivery in at least one of the following regulatory functions as defined by the WHO Global Benchmarking Tool:
• • Overarching regulatory system.
  • Marketing Authorization.
  • Vigilance.
  • Market Surveillance and Control.
  • Licensing of Premises.
  • Regulatory Inspections.
  • Laboratory Access & Testing.
  • Clinical Trials.
  • Lot Release.
• In addition, institutions providing training in medicines laws and policies, Regulatory Systems, NMRA Quality Management Systems (QMS) and Regulatory Information Management Systems (IMS), Good Regulatory Practices (GRPs), Regulatory Performance Monitoring, Pharmacoeconomics and Health Technology Assessment and medicines pricing regulation will also be considered.
• This EOI is being published for NRAs which have reached advanced WHO GBT Maturity Levels 3 or 4 and are in partnership with academic or research institutions to provide training in vaccine regulatory oversight including lot release.

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5. Criteria for selection as a Regional Centres of Regulatory Excellence
   • RCOREs are institutions or partnerships between institutions such as NRAs; university faculty; national or regional training centre or scientific and/or research institutions; industry, Quality Control Laboratory; Pharmacovigilance Centre; and/or Drug Information Centre.
   • RCOREs constitute centres of excellence with proven capacity and capabilities in training and/or delivery of service in at least one of the categories of regulatory and/or managerial functions identified under section 3.
   • The following are requirements for consideration of designation RCOREs:
     • Regulatory capability: Technical leadership and capability to accomplish its assigned mission in at least one category of regulatory functions identified in an outstanding manner.
     • Training capacity: An RCORE must have adequate technical personnel to undertake the needed training in one or more of the identified categories. This will constitute a critical mass of regulatory and managerial expertise in the defined category.
     • Governance & management systems: The institution or partners constituting an RCORE must have appropriately authorized and functional organizational structure with proven governance and support structures. These structures should be documented and submitted as supporting documents.
     • Infrastructure: An RCORE must have the necessary financial, administrative, and physical resources to deliver their mandate or functions. This includes sufficient human resources in other support functions such as management, finance and legal capacity that can provide good administrative support.
     • Partnerships: Where a potential applicant is cooperating with partners, this may be demonstrated by such agreements as Memoranda of Understanding (MOUs).
6. Selection Process
   • The selection process for RCOREs will follow the following steps:
     • Application: Call for bids and submission of expression of interest.
     • Assessment: Assessment of expressions of interest, short-listing and audits.
     • Selection: Selection shall be based on the eligibility criteria outlined above.
     • Performance Evaluation/Review: monitoring for continued performance
7. Where to send applications and supporting documents
   • AMRH Programme invites eligible institutions or partnership of institutions to express an interest to be selected as RCOREs in vaccine regulation including lot release.
   • Applications can be sent to Dr. Margareth Ndomondo-Sigonda, AMRH Secretariat at margarets@nepad.org and copy alexj@nepad.org.
   • Applications should be accompanied by comprehensive supporting documentation on meeting the eligibility criteria outlined.
   • Applications should be received on or before 31st March 2023

Disclaimer: AUDA-NEPAD, AMRH Programme and/or AMRH Partners are not bound to accept any bids submitted and reserves the right to accept or reject any bid at any time without assigning reasons.

[1] Current AMRH Partners include the NRAs, RECs, AUDA-NEPAD, Pan African Parliament (PAP), African Union Commission (AUC), the World Health Organization (WHO), World Bank, Bill and Melinda Gates Foundation, the Joint United Nations Programme on HIV/AIDS(UNAIDS), the UK Department for International Development (DFID) and the Clinton Health Access Initiative (CHAI)

DOWNLOAD THE REQUEST FOR EXPRESSION OF INTEREST FOR DESIGNATION AS AN RCORE FOR VACCINE REGULATORY OVERSIGHT IN AFRICA