Strengthening National Regulatory Authority

Strengthening National Regulatory Authority

Overview

National regulatory authorities (NRA) play a vital role in the health care system by providing regulatory oversight of all medical products such as medicines, vaccines, blood products, traditional or herbal medicines and medical devices. In Bangladesh Directorate General of Drug Administration (DGDA) is the NRA for regulation of all kinds of medicines, medical device, vaccines and other biological products. Particularly those in low- and middle-income countries, reach at least Maturity Level (ML) 3 commensurate with a stable well-functioning and integrated system of oversight for medical products.

At the global level WHO supports to use the Global Benchmarking Tool (GBT) to benchmark, evaluate and publicly designate WHO-Listed Authorities (WLAs) that have been objectively documented to perform at ML3 or ML4.likewise, WHO Bangladesh also provides technical support through benchmarking, development monitoring and evaluation of Institutional Development Plan (IDP), Strategic and action plan, competency framework, training plan, guidance documents etc.

Key facts

  • Four self-assessment and one interim assessment conducted using the WHO Global Benchmarking Tool (WHO GBT) in Bangladesh.
  • Monitoring and Evaluation of Institutional Development Plan (IDP), Strategic Plan and Action Plan developed for strengthening National Regulatory Authority (NRA).