Regulatory Systems Strengthening (RSS) programme
The World Health Organization (WHO) plays a pivotal role in supporting countries in strengthening their regulatory systems, and promoting equitable access to quality, safe, productive, and affordable medical and health products.
WHO is mandated by Resolution WHA 67.20, to support countries in strengthening regulatory systems by:
- building regulatory capacity in Member States consistent with good regulatory practices, and
- promoting regulatory cooperation, convergence and transparency through networking, work-sharing, and reliance.
Towards this end, the WHO Regulatory Systems Strengthening (RSS) programme has over the last several decades developed, implemented and refined a robust model (so-called five-step capacity building strategy) of support that involves the development of tools used for assessment and benchmarking of the regulatory system in the Member States, followed by the actual benchmarking (assessment) of the National Regulatory Authority (NRA) to identify strengths as well as areas for improvement, then tailoring of an Institutional Development Plan (IDP) to build on strengths and address areas for improvement.
A team from WHO is currently conducting a thorough review of the regulatory system, including an assessment of the implementation status of the IDPs, an assessment of laboratory testing functions and a provision of technical support to guide the Bhutan Food and Drug Authority (BFDA) in realization of maturity level 02 and then subsequently level 03.