Acts#
Key legislation governing drugs and cosmetics includes:
- The Drugs Act, 1940
- Drug Control Ordinance, 1982
- Drug Control Ordinance, 2006
- Drugs and Cosmetics Act, 2023
- Sections of Drug Cosmetics Act, 2023 in Mobile Court
Rules#
Detailed rules for the implementation of the Acts:
Guidelines#
Official guidelines issued by regulatory authorities:
- Good Clinical Practice (GCP) Guidelines
- Guidance on Approval of Locally Sourced Products (Final 30 Sep 2024)
- Guideline for Appeal Against Regulatory Decision (Rs NRA-RS-G002Ver-3)
- Guidelines for Human Vaccine Registration
- Guidelines for Management of Complaints
- Guidelines for Registration of Animal Vaccines
- Medical Device Guidelines
- National Guideline on Accreditation of Model Pharmacy and Model Medicine Shop in Bangladesh
- Stem Cell Guidelines
Policies#
National policies related to drugs and pharmaceuticals:
Other Regulatory Documents#
Miscellaneous documents, including formularies and public consultations: