- Tous > Medicine Access and Rational Use > Rational Use
- Tous > Quality and Safety: Medicines > Quality Assurance
- Tous > Quality and Safety: Medicines > Regulatory Support
- Tous > Quality and Safety: Medicines > Safety and Efficacy
- Mots-clés > drug quality
- Mots-clés > drug regulatory authorities
- Mots-clés > medicines regulation
- Mots-clés > national drug regulation
- Mots-clés > national regulatory systems - assessment
- Mots-clés > pharmacovigilance
- Mots-clés > pharmacovigilance systems
- Mots-clés > post marketing surveillance
- Mots-clés > quality
- Mots-clés > regulatory systems
(2012; 73 pages)
Nwokike, J., H. L. Choi. 2012. Assessment of the Regulatory Systems and Capacity of the Directorate General for Drug Administration in Bangladesh. Submitted to the US Agency for International Development by the Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program. Arlington, VA: Management Sciences for Health.
The DGDA invited the USAID-funded Systems for Improved Access to Pharmaceuticals and Services (SIAPS) program to provide support for a comprehensive assessment of the Bangladeshi pharmaceutical regulatory system.
The SIAPS program used the Regulatory Systems Assessment Tool (RSAT) to conduct a structured assessment of the DGDA, reviewed more than 50 documents, and conducted interviews with key informants. The assessment also reviewed the DGDA’s Operational Plan for Strengthening of Drug Administration and Management as contained in the Ministry of Health and Family Welfare (MOHFW) Health, Population, and Nutrition Sector Development Program (HPNSDP) strategic plan for 2011-2016.
The pharmaceutical sector in Bangladesh provides an example of how health and economics intermix. The justification to strengthen the Bangladesh pharmaceutical regulatory system is compelling because of the dual contribution in improving health outcomes and economic development. The DGDA’s capacity should be strengthened to protect public health while advancing industrial development in Bangladesh.