Bangladesh Profile Updated
The Bangladesh profile in ClinRegs has been reviewed and updated with the following information, which is current as of October 9, 2025:
- Updated Directorate General of Drug Administration (DGDA) document regarding the format for clinical trial protocol approval applications (See Scope of Assessment, Submission Content, and Timeline of Review)
- Additional details on sponsor and principal investigator responsibilities for adverse event reporting (See Safety Reporting)
- Reference to the resolution establishing the Bangladesh Medical Research Council (See Regulatory Authority)
- Additional supplemental DGDA guidelines and webpages related to clinical trial review and approval (See Scope of Assessment and Initiation, Agreements & Registration)
- Additional reference links to DGDA documents regarding ethics committee registration requirements and investigational product import applications (See Oversight of Ethics Committees and Manufacturing & Import)
Sources Added During this Update:
(Guidance) Guidelines for Registration of Human Vaccines (G-BGD-Vaccine) (Version 01) (Effective March 30, 2022)
Directorate General of Drug Administration
(Guidance) Guidelines for Regulatory Approvals of Stem Cell and Cell Based Products (SCCPs) (G-SCCPs) (Date Unavailable)
Directorate General of Drug Administration
(Resolution) Resolution No. ME-11/3.4/76/371. (BMRC-Res) (August 31, 1976)
Ministry of Health, Labour and Social Welfare
(Form) List of Documents Required for IRB/IEC Approval from DGDA (BGD-17) (Date Unavailable)
Directorate General of Drug Administration
(Form) Required Documents for NOC for Investigational Medicinal Products (IMPs) (BGD-18) (June 19, 2024)
Directorate General of Drug Administration
(Webpage) Directorate General of Drug Administration (DGDA) – Clinical Trial Guidelines and Forms (BGD-14 – Bengali) (Last Updated March 12, 2025)
Directorate General of Drug Administration
(Webpage) Directorate General of Drug Administration (DGDA) – List of Clinical Trials (BGD-19 – Bengali) (Last Updated May 24, 2025)
Directorate General of Drug Administration
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
(Document) Application Format for Clinical Trial Protocol Approval (BGD-22) (Date Unavailable)
Directorate General of Drug Administration