INTERGOVERNMENTAL AUTHORITY ON DEVELOPMENT (IGAD)
HEALTH AND SOCIAL DEVELOPMENT DIRECTORATE
MEDICINES REGULATORY HARMONIZATION INITIATIVE
NOTICE TO APPLICANTS
MARCH 2026
INVITATION TO SUBMIT EXPRESSION OF INTEREST (EOI) FOR JOINT ASSESSMENT OF DOSSIERS OF MEDICINAL PRODUCTS IN THE IGAD REGION
IGAD Secretariat
Avenue Georges Clemenceau,
P o Box 2653, Djibouti City
Republic of Djibouti
Website: www.igad.int
Abbreviations
| EWG MAR | Expert Working Group on Medicines Assessment and Registration |
| FPP | Finished Pharmaceutical Product |
| GMP | Good Manufacturing Practices |
| IGAD | Inter-governmental Authority on Development |
| MRH | Medicines Regulatory Harmonization |
| NRA | National Medicines Regulatory Authority |
| WHO | World Health Organization |
INTRODUCTION
Access to quality-assured, safe, and efficacious medicinal products is key to protecting public health, as well as promoting the healthy lives and well-being of the population, as provided for in the Sustainable Development Goals (SDGs). Medicines regulatory harmonization ensures quicker access and availability of life-saving medicines through work sharing and enhanced efficiencies in the market authorization and registration of medicinal products.
In this regard, the IGAD established an expert working group on medicines assessment and registration in 2019, under its Medicines Regulatory Harmonization (MRH) program. The EWG-MAR has prepared the IGAD joint dossier assessment guidelines that provides for regional collaborative joint dossier assessments among the IGAD member states, which include Ethiopia, Kenya, Uganda, Sudan, Somalia, South Sudan, and Djibouti. The EWG also developed a list of priority product categories and molecules that are eligible for IGAD joint assessments. The priority list was based on the burden of diseases in the region, the commonly used medicines, and also molecules that have a high risk of developing antimicrobial resistance (AMR).
The purpose of this document is to invite applicants to submit an Expression of Interest (EOI) for their medicinal products to be jointly evaluated by the National Medicines Regulatory Authorities (NRAs) in the region through the IGAD joint assessment procedure
The EOI invitation is published in accordance with the IGAD rules of procedure as approved by the IGAD-MRH steering committee, which comprises the heads of the respective NRAS in the IGAD region.
Submission of EOI Procedure
For an application to qualify for the joint assessment, the applicant should officially express interest in the format provided in Annex 1, the duly completed form should be submitted to the IGAD MRH secretariat at Karim.Wanga@igad.int and the medicinal product dossier should be submitted electronically on the Accumulus platform, the details of the platform (access credentials and orientation on use of the platform) will be shared to the applicants. are eligible based on the screening outcome.
Joint Assessment Process
The IGAD, in partnership with the NRAs, will coordinate the joint assessments of dossiers of the medicinal products received through this EOI. The dossier will be subjected to scientific review based on the CTD format to ascertain compliance of the medicinal product with the IGAD and international requirements for quality, safety, and efficacy. In addition, the manufacturing sites of the products will be inspected to check compliance with current Good Manufacturing Practices (cGMP).
The assessment process will entail five critical steps as described below;
Step 1: Dossier selection:
For purposes of joint assessments in the IGAD region, the IGAD secretariat, in collaboration with the EWG-MAR, will select the applications of medicinal product dossiers that are eligible for the joint assessments, taking into consideration the priority list of product categories and molecules as listed in Table 1. The applicant should commit to marketing the product in at least two or more member states of the IGAD region.
Table 1: Priority list of Medicine categories and molecules
| S/N | Disease Category | Name of Priority products (FPPs) |
| 1 | Medicines used for Reproductive Health | Oxytocin, Prostaglandins, Magnesium Sulphate, Tranexamic Acid |
| 2 | Medicines for Neonatal and Child Health | Antidiarrheals (Zinc sulphate products), products for treatment of upper and lower respiratory tract infection and pediatric formulations (Antimicrobials and Antimalarials) |
| 3 | Medicines used for management of Malaria | Antimalarial medicines based on Malaria Treatment Guidelines for each member state |
| 4 | Antimicrobial agents | Fixed dose combination products |
| 5 | Medicines used for management of cancer | Anti-cancer (Chemical and Biological) products |
| 6 | Medicines used for management of cardiovascular diseases | Medicines used for management of cardiovascular diseases |
| 7 | Medicines used for management of HIV/AIDs | Antiretrovirals |
| 8 | Medicines used for management of Tuberculosis | Anti-tuberculosis medicines |
| 9 | Medicines used for management of Neglected Tropical Diseases (NTDs) | Anti-leishmaniasis, Anti-pneumocystis, Anti-toxoplasmosis, Anti-filariasis, Anti-strongyloidiasis, Anti-leprosy medicines |
| 10 | Medicines used for management of Diabetes Mellitus | Insulin and oral hypoglycemics |
| 11 | Biologicals/immunising agents | Human vaccines |
Step 2: Dossier Screening: Before a dossier is accepted for scientific review, the dossier will be subjected to screening to verify the completeness of the dossier and compliance with the technical document format (CTD) requirements using a screening checklist. The IGAD secretariat will screen dossiers in collaboration with NRAs and assigned experts. In case a dossier is incomplete or not CTD compliant, the applicant will be informed accordingly by the IGAD secretariat.
Step 3: Dossier Assessment
Experts from two NRAs will be involved in the assessment of one dossier. The NRAs are responsible for nominating experts who will be engaged in the joint assessments based on their own national processes and procedures. The first scientific review will be done by the primary assessor; the report from the primary assessor will then be re-assessed by the secondary assessor. Where additional data/information is required, queries will be raised to the applicant. The query responses will be evaluated by the primary and secondary assessor similarly.
There will be two rounds/ cycles of assessments, where the applicant will have the opportunity to respond to the queries (allowable maximum time of 30 calendar days to respond; in each round). The regulatory clock will pause while waiting for applicant responses
GMP Verification and Inspections in the IGAD Joint Assessment Process
Where applicable, manufacturing sites associated with dossiers submitted for IGAD joint assessment will undergo verification to confirm compliance with the World Health Organization (WHO) current Good Manufacturing Practices (cGMP). The IGAD Secretariat, in collaboration with participating National Regulatory Authorities (NRAs), will coordinate joint GMP inspections for selected sites. These inspections will be conducted by designated GMP inspectors from IGAD member states, following WHO GMP standards and IGAD MRH inspection procedures. Applicants will be notified in advance of the inspection schedule and shall facilitate access to manufacturing sites, relevant documentation, and quality control records. Findings from the joint inspections will form part of the joint assessment report and will be shared with all participating NRAs for reliance and domestication
Step 4: Plenary Review and Recommendations
The final report will be subjected to peer review in plenary sessions, where experts from all seven NRAs participate in the scientific review before the final decision is made.
The primary assessor or secondary assessor will present the report, taking into consideration comments from the secondary assessor, in the plenary session of the EWG-MAR, to provide an opportunity for all the experts in the EWG to provide their comments/ scientific reviews before the final decision is made. The outcome will be either RECOMMENDATION for registration of the product or REJECTION. The outcome of the joint assessment will be communicated to the respective applicant through an official letter. The outcome will also be communicated to all the NRAs of the IGAD member states.
Standardised assessment templates will be applied to ensure compliance with international standards, as well as to ensure uniformity and quality assurance of the process.
The World Health Organization, Africa Medicines Agency (AMA), or any other collaborating regulatory authority or international organisations may participate as observers as long as they agree to confidentiality terms and they have no conflict of interest. Observers shall not participate in the decision-making process
National Registration / Domestication of regional outcome
If a positive recommendation is issued at the regional level, the applicant will submit an application to the relevant NRA for product registration. The NRA will rely on the decision of the IGAD EWG-MAR to issue market authorisation/registration of the medicinal product within a period of 90 days.
Target Timelines
| Activity Type | Proposed Target Timelines |
| Dossier screening | 30 working days excluding paused-clock time |
| Full Assessment | *210 regulatory decision days |
| Reliance Route | 90 working days |
| National domestication | 90 working days |
*Note: Target processing timelines are indicative timelines and do not necessarily represent the actual processing timelines.
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Application and Assessment Fees
The IGAD plans to implement the joint assessments in a phased approach. The IGAD will NOT charge any fees in this round of assessments covered by this REOI. However, we shall engage the industry in the near future to discuss the fee recovery program for sustainability. Applicants will pay the current requisite fees to the individual NRAs at the time of application for registration of the medicinal products, following a positive recommendation from the IGAD EWG-MAR.
Contact Information
Applications for the EOI should be submitted via email to the
Inter-governmental Authority on Development
Medicines Regulatory Harmonization Program
Karim.Wanga@igad.int
Brief Explanatory Notes
Submission of application: the applicant should officially express interest in the format provided and submit the dossier of the medicinal product through an electronic platform, which will be provided to the applicants who express interest
Dossier Format: All dossiers should follow the International Council for Harmonization (ICH): Common Technical Document (CTD) format
Who will issue market authorization/registration of medicinal product: IGAD WILL NOT issue market authorization; the IGAD EWG-MAR ONLY recommends the product for registration. Individual NRAs will issue market authorization/ registration of the medicinal products
Maintenance and Renewal of market authorization– Will follow national regulations, guidelines, and procedures for the respective member states
Product life-cycle management– Applicants will be required to communicate any post-approval changes (variations) on the medicinal product to the IGAD EWG-MAR through the IGAD secretariat. The variations will be done in accordance with the most updated World Health Organization (WHO) guidance on variations. Assessment of applications of post-approval changes (variations) will be conducted by the IGAD EWG-MAR.
Consent: Applicants will be requested to consent before sharing the assessment reports and GMP inspection reports with other NRAs or collaborating organisations outside of the IGAD region
Declaration of interest: Assessors will be required to sign a declaration of interest form to ensure they do not have interests with pharmaceutical companies that may raise conflicts of interest and affect their objectivity. The declared information will be objectively evaluated, and a determination will be made where there is a conflict of interest. This will be done before assessors are allocated dossiers for assessments.
Confidentiality- IGAD EWG-MAR will ensure that the assessors involved in the scientific review have the requisite qualifications, expertise, and experience in the relevant fields and comply with confidentiality undertaking rules of IGAD and their individual NRAs
Pre-submission meetings- The IGAD will convene the pre-submission meetings with applicants, to demonstrate how to navigate the electronic platform as well as apprise them on both administrative and technical requirements and procedures for a successful application. The IGAD may also convene a pre-submission meeting with potential applicants upon request.
National Assessment Process vs IGAD joint assessment processes: The IGAD is cognisant of member states’ sovereignty to issue market authorisation/ registration of medicinal products, within their jurisdictions, and as stipulated in the national laws and regulations. IGAD joint assessment DOES NOT replace the national process; it promotes regulatory harmonisation, convergence, collaboration, reliance, work sharing, and building capacity of NRAs in an effort to facilitate access to quality-assured, safe, and efficacious medicinal products by the population in the region. The joint assessment reduces duplication of efforts that are related to fragmented regulatory systems.
Click on the link below to apply
