SIAPS has been working with the Directorate General of Drug Administration (DGDA) to strengthen its medicines registration and licensing systems. In collaboration with the US Food and Drug Administration and the University of Washington, SIAPS conducted two assessments on pharmacovigilance systems and the national medicines regulatory system in Bangladesh.
To support the process, SIAPS facilitated a two-hour presentation on June 12, 2012, at Ikebana Hall, Lakeshore Hotel. The presentation was made by Andy Stergachis, PhD, Professor of Epidemiology and Global Health/Adjunct Professor of Pharmacy and Director, Global Medicines Program, School of Public Health, University of Washington. The presentation included global and Bangladesh perspectives on pharmacovigilance and regulatory systems, with details and examples of the assessment methodologies and expected assessment outcomes. It was followed by a two day training of data collectors, which was conducted jointly by SIAPS and DGDA. The session was attended by the Senior Secretary Kabir and the Director General of DGDA, Maj. Gen. Md. Abul Kalam Azad.
The following outcomes are expected through these assessments—
- Greater awareness of the importance of strengthening regulatory systems.
- Greater understanding of the current status of pharmacovigilance and post-market surveillance system components and their relationship to regulatory systems.
- Identification of strategies for strengthening these systems.
- Establishment of a baseline of regulatory and pharmacovigilance systems performance.
- Catalyzing evidence-based action plans for the DGDA and other stakeholders.