Snapshot

The EAC Medicines Regulatory Harmonization Program pathway has been developed by the East African Community (EAC) of East African Community (EAC).

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: Burundi Kenya Rwanda South Sudan Tanzania Uganda

When relevant, the agency relies on prior decisions from Algeria Argentina Armenia Australia Azerbaijan Brazil Canada China Colombia Cuba EU-EMA East African Community (EAC) Egypt Europe GHC-GCC Iceland India Indonesia Iran, Islamic Republic of Israel Japan Jordan Kazakhstan Lebanon Liechtenstein Malaysia Mexico Moldova, Republic of Norway Russia Saudi Arabia Singapore South Africa South Korea Switzerland Taiwan (Chinese Taipei) Turkey Ukraine United Kingdom United States WHO

The submitted application will be screened for completeness within 30 working days. In the event that the dossier is incomplete, it will be rejected. The applicant will be notified of the rejection and asked to come and collect the dossier. In case of a positive outcome during screening, the NMRA shall notify the MAH in writing that the screening has been successfully completed and place the dossier in the evaluation queue. Review of application for marketing authorization of a product will follow the appropriate evaluation queue. Priority review may be granted where the product is intended for treatment of a serious or life threatening disease. Evaluation of priority product shall be carried out within 6 months from receiving the application. Products shall be evaluated on a First in First out (FIFO) basis and the timeline for review and approval should be within 12 months. Abridged evaluation will be carried out on pharmaceutical products that are registered in any of the agreed benchmark regulatory agencies.