Steps to ensure safe, quality and effective medical products in Bangladesh

Bangladesh is currently taking important steps for improving the regulation of medical products, aiming to increase their safety, quality and efficacy across the country. The steps are part of a reforming program designed by the Directorate General for Drug Administration (DGDA) following the recommendations of World Health Organization (WHO) and with technical support from the WHO Country Office for Bangladesh and other partners.

A coalition of development organizations was created based on discussions with DGDA to strengthen the regulatory system of medical products. Nine teams have been formed to assess nine regulatory functions based on the National Regulator Authority (NRA) as essential mechanisms for reforming the framework of medical products regulation. Each team is composed of DGDA staff responsible for carrying out the function, plus one assigned technical officer from the development partners - Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program, implemented by Management Sciences for Health (MSH/SIAPS), United States Pharmacopoeial Convention, Promoting the Quality of Medicines program (USP/PQM) and WHO.

The nine assessed functions are: national regulatory system; registration and marketing authorization; vigilance; market surveillance and control; licensing establishments; regulatory inspection; laboratory access and testing; clinical trials oversight; and NRA lot release.

Next steps would be the development of an institutional development plan (IDP) and identifying the roles of the different partners in supporting DGDA. A Coalition of Interested partners (CIP) meeting is planned for July 2017, where an updated roadmap for regulatory system strengthening is to be developed.

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