Strengthening regulation of medical products in Bangladesh

6 August 2017 - Considerable progress in improving regulation of medical products in Bangladesh has been undertaken since March 2016, when a coalition of national, international and governmental bodies agreed a joint roadmap towards safer, better and more efficient medical products in the country.

On 23-24 July 2017, the Directorate General for Drug Regulatory Affairs (DGDA), with technical support from World Health Organization (WHO), Country Office for Bangladesh, held a coalition of interested partners meeting (CIP) aiming to review the progress of the joint roadmap and to assess the further steps needed in achieving the desired standards of medical products in Bangladesh. This progress was reviewed in light of recent developments including the National Medicines Policy 2016, the DGDA Five-year Strategic Plan, and a national regulatory authority self-assessment using WHO NRA benchmarking tool.

In the outcomes of this event, the partners observed that progress during the last year was considerable, reflecting commitment of all parties to improve coordination of efforts to provide support to DGDA, the national regulatory authority. It was noted that actions must be country-owned and sustained to achieve desired outcomes and that all parties now working together according to one plan was a significant achievement.

The CIP members agreed that WHO global benchmarking tool provides a well-established process for determining maturity of regulatory systems and areas for improvement against established indicators. At the same time the institutional development plan (IDP) represents detailed actions to be taken to comply with indicators that collectively define a well-functioning regulatory system (Maturity Level 3) while DGDA strategic plan provides a higher level five-year blueprint on how to address key gaps and priorities towards achieving ML 3 and GoB health sector plan. The CIP’s role is working together with DGDA to achieve these objectives in a more effective, sustainable manner.

The CIP is led by DGDA and technically supported by WHO, currently gathering representatives of Management Sciences for Health, United States Pharmacopeial Convention, USAID, UK Aid, and other development partners.

Next steps include further refinements to how the Coalition operates, both within Bangladesh and globally. A draft terms of reference defining the operating principles of the CIP is currently under preparation.

WHO remains committed in supporting the Bangladesh government to achieve the highest standards for medical products by working together for strengthening the regulatory system of the country.