Bangladesh: Drugs

Clinical Trial Data Requirements

Clinical trial requirements are outlined in Guidance for Industry on Submission of Clinical Trial Application for Evaluating Safety and Efficacy. These are the primary sections of the application:

Section A: General Information
1. Introduction about the company
2. Administrative Headquarters
3. Manufacturing Facilities
4. Regulatory permissions/approvals
5. Regulatory and intellectual property status in other countries

Section B: Chemistry, Manufacturing, Control
1. Product description
2. Product development
3. Information on Drug Substance
4. Information on Drug Product

Section C: Nonclinical data (compliance as per relevant WHO-Technical Review Series)

Section D: Study protocol

Clinical Trial Import Authorization

Must submit an import license application.

In-Country Manufacturing Requirements

Clinical trial requirements are outlined in Guidance for Industry on Submission of Clinical Trial Application for Evaluating Safety and Efficacy. Products manufactured in countries with functional NRAs (as deemed by the WHO), WHO prequalified manufacturers, or "well established vaccine producing countries like India and China" are exempt from conducting new clinical trials in Bangladesh.

Phase 3 Requirements (if different)

The Guidance for Industry on Submission of Clinical Trial Application for Evaluating Safety and Efficacy outlines the following requirements for a Phase III application:

Section A: General Information
1. Introduction about the company
2. Administrative Headquarters
3. Manufacturing Facilities
4. Regulatory permissions/approvals
5. Regulatory and intellectual property status in other countries

Section B: Chemistry, Manufacturing, Control
1. Quality information (Chemistry, Pharmaceutical and Biological)

Section C: Nonclinical data (compliance as per relevant WHO-Technical Review Series)

Section D: Study protocol

The primary difference between these requirements and Phase I/II requirements is Section B.

Precedent (Clinical Trials Approved/Denied in Last 2 Years)

28 clinical trials approved from June 2012 to June 2014.

Product Registration Data Requirements

Rules for market authorization for drugs are outlined in Guidance for Industry.

Within the DGDA, the Drug Control Committee (DCC) is an advisory committee responsible for drug registration. If manufacturing is partially carried out in Bangladesh, sponsors must submit CMC data for the first three consecutive batches made in Bangladesh compared to the product produced in its country of origin. Post marketing surveillance and stability data must be annually submitted to the DGDA for registered vaccines.

 Module 1:
1. Comprehensive table of contents
2. Administrative information
Module 2:
1. Table of contents
2. Introduction
3. Overall quality summary
4. Overview of non-clinical studies
5. Non-clinical summary
6. Overview of clinical studies
7. Clinical summary
Module 3:
Quality information (Chemical, Pharmaceutical and Biological)
1. Table of contents
2. Quality contents
3. Bibliography
Module 4:
Non-clinical reports
1. Table of contents
2. Report on studies
3. Bibliography
Module 5:
Report of Clinical Studies
1. Table of contents
2. Contents: Reports of clinical studies
3. Bibliography

For attenuated vaccines, submit evaluation of possible "shedding" (excretion) of micro-organism. For new substances used in formulation (adjuvants, stabilizers, additives), or other modes of administration/new combined vaccines, must provide toxicological studies.

Co-administration studies with other vaccines.

Non-inferiority studies (for combined vaccines or approved vaccines made by new manufacturers.

Product Registration Timelines

According to the Journal of Drug Delivery and Therapeutics, registration can take 8-24 months.

Product Registration Process for Products Approved by SRA/WHO

To be registered, products that are manufactured in countries with function NRAs/WHO prequalified  or "well established vaccine producing countries like India and China (having population with similar genetic make up" are exempt from clinical trials. in this case, CMC data, pre-clinical data, and clinical trial data from country of origin should be submitted for registration.

Post Registration Labeling Requirements

Labelling requirements are outlined in the Drug Act, 1940. The act is available here

Post Registration Pharmacovigilance Requirements

Annual submission of post marketing surveillance and ongoing stability data.

For more background information on pharmacovigilance requirements in Bangladesh, consult the USAID/SIAPS report "Pharmacovigilance Systems in Five Asian Countries

Last Updated

September 24, 2014.