REQUEST FOR EXPRESSION OF INTEREST (REOI) -INDIVIDUAL CONSULTANT

                                                                                          FOR

 Consultancy to develop the Regional Medicines Regulation Reliance Framework for the Inter-governmental Authority on Development (IGAD) in line with the Africa Continental Medicines Regulation Reliance Framework

---

BACKGROUND

1. Background and Context

Building and maintaining strong regulatory systems in IGAD member states requires skilled professionals, adequate funding, and efficient processes. The WHO Guidelines on Good Regulatory Practices emphasize that globalization, rapid advancements in health technologies, and increasingly complex supply chains make international cooperation among regulators more important than ever. By working together, regulatory bodies can ensure that medical products used in the region are safe, effective, and of high quality. Given the growing challenges of regulation, National Regulatory Authorities (NRAs) need to adopt smarter, more collaborative approaches. By pooling expertise and resources, they can reduce duplication of efforts and focus on the areas that need the most attention.

Harmonizing and aligning regulations across countries is key to achieving universal health coverage. In Africa, regulatory reliance has become an especially important strategy. This approach makes the regulatory process more efficient by encouraging collaboration, trust, and shared decision-making. It benefits everyone—patients, consumers, governments, healthcare providers, industry, and international partners—by ensuring quicker access to safe and high-quality medical products.

Regulatory reliance means that one country’s regulatory authority can use assessments or approvals from another trusted reference authority or international organization when making its own decisions. However, the final responsibility remains with the relying authority, ensuring accountability and independence. By adopting this model, IGAD member states can strengthen their regulatory systems, improve efficiency, and work more closely together in regulating health products.

1. OBJECTIVE

IGAD seeks to engage the service of a consultant to develop a regional reliance framework in alignment with the AMRH Continental Regulatory Reliance Framework to guide the implementation of principles of Good Regulatory Practices for regulation of medical products (GReIP) at the national level in various regulatory activities across all regulatory functions. The specific objective of the assignment is to develop a regional reliance framework and implementation guidelines consisting of practical guides, case studies, and a more comprehensive repository of examples of reliance activities.

The specific objectives for the consultants are as below:

1. Conduct a comprehensive desk review of existing regulatory reliance pathways implemented by IGAD and EAC regions across marketing authorization and regulatory inspection functions for medicines and vaccines and in accordance with Good Reliance Practices for regulation of medical products (GRelP).
2. Work with the AMRH initiative to localize the continental reliance framework to IGAD and EAC region.

• Conduct a pre-development consultation with IGAD technical teams on areas to be considered, barriers and recommendations to enhance reliance on regulatory recommendations and decisions amongst regulators in Africa.

1. Develop a regional Reliance Framework for marketing authorisation and regulatory inspection function that will promote a more efficient approach to the regulation of medical products as per WHO Global Benchmarking Tool (GBT) plus for medicines and vaccines, and with practical guides, illustrative examples of reliance approaches and their implementation.
2. Conduct a post-development consultation with IGAD technical teams on areas to be considered, barriers and recommendations to enhance reliance on regulatory recommendations and decisions amongst regulators in Africa.
3. Develop template for assessment of sameness in view of the IGAD/EAC reliance framework

• Incorporate inputs/feedback from IGAD technical teams.
• Present Localized Regional Reliance Framework to relevant IGAD personnel for validation and adoption.

DELIVERABLES

The Consultant is expected to support IGAD to adopt and adapt the AMRH-developed regulatory reliance framework and support IGAD in implementing principles of reliance in regulatory decision-making. The consultant will work closely with IGAD technical staff to develop, validate and roll out the framework

1. LOCATION AND DURATION OF THE ASSIGNMENT

The Consultant will conduct the assignment partially remotely and partially on site in the IGAD region where necessary. The assignment is for twenty (20 days) from the date of the signing of the contract. All work must be completed by 31st July 2025.

1. Required Qualifications, Experience and Skills

Interested individual applicants should possess the following qualifications and experience. Please apply only if you are from the IGAD region.

   Education qualifications

Prospective consultants should have a minimum of a master’s degree in pharmacy, pharmaceutical sciences, medicine, chemistry, medical laboratory sciences, biomedical engineer, or any other related field.

Experience and Skills

• At least 10 years as a practitioner or consultant on matters related to implementation of regulatory networks and convergence, regulatory systems strengthening or harmonization initiatives.
• A candidate with experience working in a medical products regulatory body, Regional Medicines Regulatory Harmonization programme or international harmonization initiatives is highly preferred.
• Good knowledge on the AMRH Initiative, RECs MRH initiatives and the field of Africa Medical Products Regulation.
• A professional with exposure to international collaboration; previous experience working with IGAD will be an added advantagee
• Expert knowledge of English is essential.

The Selection shall follow the IGAD procurement procedures. The Intergovernmental Authority on Development (IGAD) now invites interested and eligible consultants who are members of the IGAD member states to submit Expressions of Interest (EOI) for the above assignment. Detailed terms of reference (TORs) will be shared with shortlisted consultants.

• Interested consultants may obtain further information from Monday to Friday, 8:00am – 4:00pm EAT, by email to Wanga@igad.int  with copies to glory.karimi@igad.int  Please note that at this stage, no PROPOSALS whether TECHNICAL or FINANCIAL are requested.

HOW TO APPLY

The consultant should submit their Expression of Interest (EOI), Curriculum Vitae (s) and academic credentials to glory.karimi@igad.int  with a copy to procurement@igad.int no later than Monday, 1^st May 2025, at 23:59 Hrs. EAT (GMT+3).

Download the attached ToR document in PDF below 
REOI MRH (1)