Tanzania Profile Updated

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

• Government of Tanzania law (effective May 2023) and regulations (effective July 2023) on personal data protection, including information on responsible parties, collection, processing, and consent (See Personal Data Protection)
• Charter for the National Health Research Ethics Committee (NatHREC) covering responsibilities and activities (See Ethics Committee) 
• National Institute for Medical Research (NIMR) accreditation guidance issued in March 2023 for institutional ECs (See Oversight of Ethics Committees) 
• Tanzania Medicines and Medical Devices authority (TMDA) guidance released in April 2023 on good manufacturing practices for inspection of manufacturing facilities for human medicinal products (See Manufacturing & Import)
• Multi-agency guidance updated in 2023 on ethics for health research in Tanzania (See Ethics Committee, Clinical Trial Lifecycle, Informed Consent, and Specimens topics) 
• NIMR standard operating procedures governing the NatHREC updated in 2023 (See Ethics Committee, Clinical Trial Lifecycle, Informed Consent, and Specimen Import & Export, and Consent for Specimens topics) 
• Updated TMDA frequently asked questions on permit issuance, research registration, fees for foreign researchers, and submission process. (See Regulatory Authority, Regulatory Fees, and Submission Process) 
• TMDA webpage on clinical trials control, including regulatory authority, payment instructions for TMDA fees, and reviews (See Regulatory Authority topic) 
• TMDA webpage on adopted guidelines of the International Council for Harmonisation (ICH) of Technical Requirements for Pharmaceuticals for Human Use (See Regulatory Authority) 
• TMDA webpage on promoting transparency of clinical trial oversight in Tanzania (See Risk & Quality Management)

Sources Added During this Update:

(Guidance) Accreditation Guide for Institutional Research Ethics Committees in Tanzania (IERC-Accredit) (March 2023)
National Institute for Medical Research

(Guidance) Guidelines for Good Manufacturing Practices – Inspection of Human Medicinal Products Manufacturing Facilities (GMP-Insp) (April 2023)
Tanzania Medicines and Medical Devices Authority

(Guidance) The Ethics Clearance Process – Client Service Charter (Version 2) (NatHREC-Charter) (April 2023)
National Institute for Medical Research

(Legislation) The Personal Data Protection Act, 2022 (PDP-Act) (Effective May 1, 2023)
Parliament

(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

(Notice) Publication of Clinical Trial Public Assessment Reports and GCP Public Inspection Reports (Pub-Rprts) (June 1, 2023)
Tanzania Medicines and Medical Devices Authority

(Notice) Timelines for Issuance of Clinical Trial Certificates (CTC-Time) (May 8, 2023)
Tanzania Medicines and Medical Devices Authority

(Webpage) Clinical Trials Control (TZA-4) (Current as of March 1, 2024)
Tanzania Medicines and Medical Devices Authority

(Webpage) ICH Adopted Guidelines (TZA-9) (Current as of March 1, 2024)
Tanzania Medicines and Medical Devices Authority

(Webpage) Research Coordination (TZA-16) (Current as of March 1, 2024)
Tanzania Commission for Science and Technology

Sources Revised During this Update:

(Guidance) Guidelines on Ethics for Health Research in Tanzania (G-EthicsHR-TZA) (Third Edition) (2023)
National Institute for Medical Research

(Document) Standard Operating Procedures for the National Health Research Ethics Committee (TZA-5) (3rd Edition) (2023)
National Institute for Medical Research

(Webpage) Frequently Asked Questions (FAQs) (TZA-47) (Current as of March 1, 2024)
Tanzania Commission for Science and Technology

(Webpage) Health Research Regulations (TZA-18) (Current as of March 1, 2024)
National Institute of Medical Research

(Webpage) ICH Efficacy Guidelines (TZA-24) (Current as of March 1, 2024)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use