ISO 9001: 2015: CERTIFIED

PUBLIC NOTICE

23^rd May, 2025

DRAFT GUIDELINES ON REGULATORY RELIANCE FOR MARKETING AUTHORIZATION OF MEDICINAL PRODUCTS

1. The Tanzania Medicines and Medical Devices Authority (TMDA) would like to inform our esteemed stakeholders that, the Guidelines on Regulatory Reliance for Marketing Authorization of Human Medicinal Products have been developed.
2. The Guidelines aim at guiding the applicants on the registration requirements and review pathways for applications for marketing authorization of medicinal products submitted through the reliance procedure.
3. The reliance procedure is intended to accelerate review process of applications and reduce the time for decision making to improve access to medicines of good quality, efficacious and safe.
4. In view of this, TMDA is inviting comments on these draft guidelines which will help to finalize the document. The comments should be compiled in the format document provided here. (Click here. to access the template).
5. Please send electronically your comments to the Authority through official e-mail; medicines@tmda.go.tz, and copied to felchism.apolinary@tmda.go.tz.
6. The draft guidelines will be available for comments until 15th June, 2025 on the TMDA website at the following link.
7. We thank you for your continued cooperation.