Snapshot

The IGAD Joint Assessment Procedure pathway has been developed by the Intergovernmental Authority on Development (IGAD) Region of Intergovernmental Authority on Development (IGAD) Region.

This pathway can be used where Medicines for reproductive health emergencies, medicines used for the management of child and neonatal health, medicines for the management of malaria, antimicrobial agents, cancer medicines, medicines used for the management of cardiovascular disease, medicines for the management of mental health conditions, medicines used for the management of HIV/AIDS, tuberculosis, neglected tropical diseases, diabetes mellitus, and medicines used for the management of vaccine preventable diseases..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Regional regulatory initiatives can help optimize the efficient use of an agency’s resources. The following countries participate in this initiative/pathway: Djibouti Eritrea Ethiopia Kenya Somalia South Sudan Sudan Uganda

Ethiopia FDA is the lead country and coordinator in the IGAD joint assessment procedure. The joint assessment process begins with consent from the marketing authorization holder (MAH). Then selection of primary and secondary NMRA is done by EWG-MAR objectively in a transparent and accountable manner to allow best use of available technical experts in the region. For appropriate assessment, there are always two NMRAs for any particular dossier: first scientific assessment will be done by the primary NMRA; assessment report from the primary NMRA and the dossier will then be re-assessed by the secondary NMRA. NMRAs are responsible for the nomination of technical experts (i.e. assessors) using national procedures. TIMELINES: Day 0 – dossier receipt, Day 30 – dossier screening, followed by a clock stop to allow applicant to update dossier following any omissions or errors. Day 30-110 – assessment cycle 1: primary and secondary NMRA assess updated dossier Day 110 – clock stop, questions to applicant 1st cycle Day 110-190 – assessment cycle 2: primary and secondary NMRA assess updated dossier Day 190 – clock stop, questions to applicant 2nd cycle Day 210 – regional regulatory decision after regional full assessment. (abbreviated route = 90 working days) Day 240 – national regulatory decision Note: the target processing timelines are indicative timelines to be used for reference and planning purposes. They do not necessarily represent the actual processing timelines for the applications.