Tanzania Profile Updated

The Tanzania profile in ClinRegs has been reviewed and updated with the following information, which is current as of April 3, 2025:

• 2024 guidance from the Tanzania Medicines and Medical Devices Authority (TMDA) on payment procedures for overseas customers (See Regulatory Fees)
• TMDA regulations and guidance on good storage and distribution practice of pharmaceutical products (See Product Management)
• Updated TMDA requirements and additional details on good manufacturing practice inspections and compliance (See Manufacturing & Import, Quality Requirements, and Product Management)
• Information on appealing a TMDA decision (See Scope of Assessment and Timeline of Review)
• Additional details regarding who is responsible for data management and quality and TMDA access to source data/documents (See Risk & Quality Management)
• Updated Commission for Science and Technology (COSTECH) contact information (See Regulatory Authority)
• 2025 ethical clearance fees from the National Institute for Medical Research (NIMR) (See Ethics Committee Fees)
• Details from NIMR on ethics committee leadership (See Ethics Committee)
• Details from NIMR on consent for secondary use of materials or data (See Documentation Requirements)
• Updated NIMR data transfer agreement for researchers and organizations (See Forms)

Sources Added During this Update:

(Guidance) Guidelines for Good Storage and Distribution Practices of Pharmaceutical Products (G-GSDP) (May 2024)
Tanzania Medicines and Medical Devices Authority

(Guidance) WHO Technical Report Series (WHO-TRS) (Current as of April 3, 2025)
World Health Organization

(Notice) Payment Procedures for Overseas Customers (Pay-Overseas) (April 30, 2024)
Tanzania Medicines and Medical Devices Authority

(Regulation) The Tanzania Medicines and Medical Devices (Goods Storage and Distribution Practices) Regulations, 2021 (GSDP-Reg) (2021)
Tanzania Medicines and Medical Devices Authority

(Document) Payment for Ethical Clearance Fees (TZA-17) (Effective January 1, 2025)
National Institute for Medical Research

(Webpage) GMP Inspection (TZA-19) (Current as of April 3, 2025)
Tanzania Medicines and Medical Devices Authority

Sources Revised During this Update:

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

(Regulation) The Personal Data Protection (Personal Data Collection and Processing) Regulations, 2023 (PDP-Reg-TZA) (Effective July 4, 2023)
Ministry of Information, Communication and Information Technology

(Webpage) Frequently Asked Questions (FAQs) (TZA-47) (Current as of April 3, 2025)
Tanzania Commission for Science and Technology