Pharmacovigilance System in Bangladesh: A Regulatory Perspective
Volume 3 ; Issue 1 ; in Month : Jan-June (2019) Article No : 134
Mohammad Wasif Khan
National pharmacovigilance centre of a country coordinates the overall activity of pharmacovigilance in collaboration with international regulatory authorities like WHO-UMC etc. The pharmacovigilance system establishment in public health has encouraging impact on health-care system improvement. To ensure the safety of medication system in Bangladesh, DGDA is leading from the front. In 2013, the Ministry of Health and Family Welfare, Bangladesh declared the DGDA as the National Pharmacovigilance Centre for Bangladesh, with the ADRM cell overseeing the centre’s activities. The MOHFW also set up the independent ADR Advisory Committee to work in conjunction with the ADRM cell to provide technical guidance for implementing PV activities, evaluating ADE reports, and recommending regulatory decisions and actions to ensure medicine safety. The DGDA has developed guidelines and strategies to implement PV activities across the country in cooperation with all stakeholders. The salient features of current PV regulations in Bangladesh are: An appropriate PV system is in place within the company to conduct post-marketing surveillance activities; Suspected adverse reactions to drugs must be reported using the electronic version of the reporting form available in the fillable pdf on DGDA website and submitted to the ADRM cell; Submit PSURs and company-sponsored post-registration study reports to the ADRM cell on a quarterly basis; Respond promptly and fully to requests for risk/benefit information from the ADRM cell.
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