Medicines Registration Guidelines
This page provides a list of guidelines that may be needed for the preparation of applications for marketing authorization with the Tanzania Medicines and Medical Devices Authority (TMDA).
In addition to the internal guidelines listed below, TMDA also applies other international standards and guidance documents, including guidelines developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the World Health Organization (WHO)
The TMDA guidelines are provided below: -
- Guidelines on Regulatory Reliance for Marketing Authorisation of Human Medicinal Products, July, 2025 Download
- Guidance on the Quality and Clinical Requirements for Inhalation and Nasal Medicinal Products, May, 2024 Download
- Guidelines on Processing of Applications for Registration of Medicinal Products through Non-Routine Procedure, April, 2023 Download
- Guidelines on Good Review Practices, April, 2023 Download
- Guidelines for Emergency Use Authorization of Medicinal Products, April, 2023 Download
- Good Reliance Practices, March, 2023 Download
- Good Regulatory Practices for Medical Products, March 2023 Download
- Guidelines on Submission of Documentation for Marketing Authorization of Human Vaccines, March 2020 Download
- Guidelines for Emergency Use Authorization of Medicinal Products, September, 2022 Download
- Guidelines on Variations on Registered Medicinal Products, March 2020 Download
- Guidelines On Submission of Documentation for Marketing Authorization of Herbal Medicinal Products,July, 2020 Download
- Guidelines on Submission of Documentation for Renewal of Marketing Authorization of Human and Veterinary Medicinal Products, January 2021 Download
- Guidelines on Variations of Registered Vaccines, February, 2021 Download
- Compendium Guidelines for Marketing Authorization of Medicinal Products, July, 2020 Download
- Guidelines for Submission of Documentation for Marketing Authorization of Biocidals (Antiseptics and Disinfectants) Products, August 2020. Download
- Guidelines on Submission of Documentation for Registration of Immunological Veterinary Products, March 2020. Download
- Guidelines on Submission of Documentation for Registration of Veterinary Medicinal Products, March 2020. Download
- Guidelines for Control of Promotion and Advertisement of Medicines, Medical Devices and Cosmetics in Tanzania, First Edition, January 2015. Download
- Guidelines on Submission of Documentation For Marketing Authorization of Similar Biotherapeutics Products, March 2020. Download
- Guidelines on Submission of Documentation for Marketing Authorization of Biotherapeutics Products, March 2020. Download