Dhaka, 15 August 2018: Directorate General of Drug Administration (DGDA) launched the National Guideline on the Pharmacovigilance System in Bangladesh to provide a basic framework for detection, assessment, understanding and prevention of adverse effects of pharmaceutical products. Such products include, vaccines, medical devices, biologics, blood products, herbal medicines as well as traditional and complementary medicines.
Mohammad Nasim, MP, Minister for Health and Family Welfare, Government of Bangladesh launched the guideline as the chief guest at the Dissemination Program of National Guideline on the Pharmacovigilance Systems in Bangladesh, held at DGDA, Dhaka. World Health Organization (WHO) Bangladesh and United States Agency for International Development (USAID) provided technical and financial support for the guideline development and to organizing the program.
The guideline outlines what, why, when, where and how to report information on adverse events to the DGDA where the reports will be analyzed and regulatory action taken when necessary.
The health minister also launched the Guideline for Registration of Biosimilar Products 2018 with a view to assist importers, manufacturer and other relevant stakeholders to demonstrate that proposed therapeutic protein product is biosimilar to a reference product.
The meeting was attended by Advisor to the Prime Minister on private sector development Salman F Rahman, Director General, DGDA Major General Md. Mustafizur Rahman, WHO Technical Expert on Essential Drugs and Medicines Mohamed Ramzy Ismail, USAID Project Management Specialist Dr Samina Chowdhury and senior health professionals. Participants shared views to operationalize the two guidelines for ensuring improve patient care and safety and promote the rational use of medicines.
The launch of the guidelines is an initiative to ensure uniformity in the execution of safety and effective monitoring of pharmaceutical related activities and health products in Bangladesh.