THE UNITED REPUBLIC OF TANZANIA MINISTRY OF HEALTH TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY

ISO 9001: 2015: CERTIFIED

PUBLIC NOTICE

30^th June, 2026

REGULATORY RELIANCE PATHWAYS FOR MARKETING AUTHORISATION OF HUMAN MEDICINAL PRODUCTS

1. The Tanzania Medicines and Medical Devices Authority (TMDA) wishes to inform pharmaceutical manufacturers, applicants, local representatives, importers, and all stakeholders that it has finalized and published the Guidelines on Regulatory Reliance for Marketing Authorization of Human Medicinal Products, July 2025.
2. The Guidelines were developed to facilitate regulatory reliance in the assessment and registration of human medicinal products. This initiative leverages regulatory decisions and scientific assessments from competent National Regulatory Authorities (NRAs), recognized organizations, and regional harmonization initiatives, thereby aligning with international best practices and World Health Organisation (WHO) recommendations.
3. In accordance with the procedures prescribed in the guidelines, TMDA will accept applications for the registration of human medicinal products through the selected reliance pathway, provided such products have already been authorized by a Reference Regulatory Authority (RRA).
4. The implementation of this pathway is intended to: -
   1. Accelerate the review process and reduce decision-making timelines, thereby improving patient access to safe, effective, and high-quality medicines;
   2. Minimize the duplication of regulatory efforts by relying on assessments conducted by trusted regulatory authorities; and
   3. Optimize the utilization of regulatory resources and enhance operational efficiency.
5. In view of the above, applicants wishing to utilize the reliance pathway must submit their applications in line with the requirements stipulated in the Guidelines, including all prescribed supporting documentation.
6. Furthermore, applications submitted under the reliance pathway that comply with the prescribed criteria shall be evaluated, with outcomes communicated within ninety (90) working days from the date the application is accepted for review.
7. The guidelines on reliance are available on the TMDA website and can be accessed at: tmda.go.tz/publications/42
8. All stakeholders and applicants are encouraged to familiarize themselves with the provisions of the Guidelines and take advantage of this pathway to facilitate the timely registration of medicinal products.
9. We thank you for your continued cooperation.

Issued by:
Director General,
Tanzania Medicines and Medical Devices Authority
P.O. Box 1253, Dodoma.
Tel; +255 222 450512/658 445222/777 700002
Fax: +255 222450793
Email: info@tmda.go.tz
Website: www.tmda.go.tz