Authors: Barsha Dewan, Mashrar Faujdar
Abstract: A country's national pharmacovigilance centre manages total pharmacovigilance work in coordination with international regulatory agencies such as WHO-UMC, etc. The introduction of a pharmacovigilance system in public health has had a positive influence on the improvement of the health-care system. DGDA is leading from the front to safeguard the safety of Bangladesh's medicine system. The DGDA was designated as the National Pharmacovigilance Centre for Bangladesh by the Ministry of Health and Family Welfare in 2013, with the ADRM cell monitoring the center's work. The MOHFW has established an independent ADR Advisory Committee to collaborate with the ADRM cell in providing technical assistance for PV operations, analysing ADE reports, and suggesting regulatory choices and steps to safeguard medication safety. In collaboration with all stakeholders, the DGDA has produced guidelines and plans for implementing PV initiatives across the country. The following are the key aspects of current PV legislation in Bangladesh: A suitable PV system is installed within the firm to undertake post-marketing monitoring operations; Suspected adverse drug reactions must be reported using the electronic version of the reporting form, which is accessible in fillable pdf format on the DGDA website, and sent to the ADRM cell. Quarterly submit PSURs and company-sponsored post-registration study reports to the ADRM cell; Respond to ADRM cell requests for risk/benefit information immediately and completely.
Keywords: Pharmacovigilance; WHO-UMC; DGDA; ADR; ADE; ADRM Cell; MOHFW; ADRAC; PSUR; RMP; Serious Adverse Event
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