Tanzania Profile Updated

The Tanzania profile in ClinRegs has been reviewed and updated with the following information:

• Updated research registration and clearance guidance from the Tanzania Commission for Science and Technology (COSTECH) (See Regulatory Authority topic and Clinical Trial Lifecycle topic)
• Updated FAQs from COSTECH on research permits (See Regulatory Authority, Scope of Assessment, Submission Content, and Timeline of Review)
• COSTECH information on its functions, services, vision, mission, and organization (See Regulatory Authority)
• Tanzania Medicines and Medical Devices Authority (TMDA) notice for foreign manufacturers regarding the renewal application process (See Manufacturing & Import)
• Information on agencies relevant to research involving human DNA and research conducted in a local area (See Regulatory Authority, Scope of Assessment, and Timeline of Review)
• References to the National Institute for Medical Research’s clinical trial application workflow (See Regulatory Authority, Scope of Assessment, Submission Process, Timeline of Review, Initiation, Agreements & Registration)
• A list of TMDA guidelines for conducting clinical trials (See Regulatory Authority and Product Management)
• Updated guidance on inspections of human medicinal products manufacturing facilities (See Manufacturing & Import and Quality Requirements)

Sources Added During this Update:

(Legislation) Human DNA Regulation Act, 2009 (DNA-Act) (May 15, 2009)
Parliament

(Legislation) Government Chemist Laboratory Authority Act (GCLA-Act) (Amended through June 30, 2025)
Parliament

(Legislation) The Tanzania Commission for Science and Technology Act, Chapter 226, R.E 2023 (COSTECH-Act) (Last Revised December 31, 2023)
Parliament

(Regulations) The Human DNA (General) Regulations, 2019 (DNA-Regs) (August 9, 2019)
Ministry of Health

(Notice) Submission of Applications for Renewal of GMP Compliance for Foreign Manufacturers (Frn-Rnw-Mnfct) (December 29, 2025)
Tanzania Medicines and Medical Devices Authority

(International Guidance) ICH Guidelines (TZA-28) (Current as of June 3, 2026)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

(Webpage) Clinical and Non-Clinical Trial Application and Registration (TZA-20) (Current as of June 3, 2026)
National Institute for Medical Research

(Webpage) Guidelines for Conducting Clinical Trials (TZA-27) (Current as of June 3, 2026)
Tanzania Medicines and Medical Devices Authority

(Webpage) Mission and Vision (TZA-52 - Swahili) (January 15, 2026)
Prime Minister's Office, Regional Administration and Local Government

(Webpage) Organogram (TZA-25) (Current as of June 3, 2026)
Tanzania Commission for Science and Technology

(Webpage) Our Services (TZA-21) (Current as of June 3, 2026)
Tanzania Commission for Science and Technology

(Webpage) Vision, Mission & Core Values (TZA-22) (Current as of June 3, 2026)
Tanzania Commission for Science and Technology

Sources Revised During this Update:

(Legislation) The Law of the Child Act, Chapter 13 (ChildAct) (Last Amended October 11, 2024)
Parliament

(Regulation) The Tanzania Medicines and Medical Devices (Good Storage and Distribution Practices) (Amendment) Regulations, 2022 (GSDP-Reg) (March 25, 2022)
Tanzania Medicines and Medical Devices Authority

(Guidance) Guidelines for Good Manufacturing Practices – Inspection of Human Medicinal Products Manufacturing Facilities (GMP-Insp) (Third Edition) (July 2025)
Tanzania Medicines and Medical Devices Authority

(Guidance) National Research Registration and Clearance Guidelines (G-ResearchClearance) (2024)
Tanzania Commission for Science and Technology

(Webpage) Frequently Asked Questions (FAQs) (TZA-47) (Current as of June 3, 2026)
Tanzania Commission for Science and Technology