Bangladesh Profile Updated
The Bangladesh profile in ClinRegs has been reviewed and updated with the following information:
- Updated Directorate General of Drug Administration (DGDA) guidelines on good clinical practice (GCP), including revisions related to the DGDA review of clinical trial protocols, oversight of institutional review boards (IRBs), and multiregional clinical trials (See the Regulatory Authority, Ethics Committee, and Clinical Trial Lifecycle topics, and Site/Investigator Selection)
- Additional details from the GCP guidelines related to investigator requirements, record keeping, and compensation disclosure (See Site/Investigator Selection, Data & Records Management, and Required Elements)
- New drugs and cosmetics legislation providing added information on DGDA functions and role in review of clinical trial protocols and investigational product manufacturing/import licensing (See Regulatory Authority, Scope of Assessment, and Manufacturing & Import)
Sources Added During this Update:
(Legislation) Drugs and Cosmetics Act, 2023 (DrugsCosAct – Bengali) (English-DrugsCosAct – Unofficial Translation) (September 18, 2023)
Bangladesh National Parliament
(Form) Application for Institutional Review Board (I.R.B) Clearance - Student (BGD-10) (Date Unavailable)
Bangabandhu Sheikh Mujib Medical University
(Form) Application for Institutional Review Board (I.R.B) Clearance - Teacher (BGD-11) (Date Unavailable)
Bangabandhu Sheikh Mujib Medical University
(International Guidance) ICH Harmonised Guideline: General Principles for Planning and Design of Multi-Regional Clinical Trials (E17) (BGD-6) (Final Version) (November 16, 2017)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Sources Revised During this Update:
(Guidance) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products Bangladesh (BGD-GCP) (Version 02) (Effective December 2023)
Directorate General of Drug Administration