Washington, DC, December 15, 2017 (PAHO/WHO) - Representatives from National Regulatory Authorities (NRAs) met in Washington D.C. to contribute to the discussion for the development of a common Global Benchmarking Tool (GBT) to strengthen national regulatory systems to be applied at all World Health Organization's (WHO) regions.
The WHO GBT is a tool for evaluation of national regulatory systems of all medical product streams (e.g. medicines, vaccines, medical devices, and blood products) that aims to ensure policy coherence, and reduce the unnecessary burden of assessments, costs and duplications for countries.
After a public consultation process, planned for 8 January to 16 February 2018, definition of criteria for piloting the tool in several NRAs with varying regulatory capacity and settings will be set by WHO and WHO Regional offices. It is expected that NRAs actively participate in the public consultation process of the GBT.
The development of the GBT is the conclusion of several coordination meetings between WHO and PAHO together with the support of experts from NRAs held in 2016-2017. PAHO and WHO developed a roadmap for finalization of the GBT by December 2017, which includes the involvement of countries, and encompasses:
- (1) development of the tool through internal revision to align existing ones with the involvement of regulatory experts from selected Member States;
- (2) consultation with regulatory experts from NRAs around the world;
- (3) piloting of the tool within diverse regulatory settings;
- (4) finalization of the tool including editing (and translation);
- (5) updating the relevant computerized tool; and
- (6) release and publication of the tool and relevant materials by second semester of 2018.
The development and implementation of the global benchmarking tool will allow Member States to strengthen their regulatory capacities and will serve as the basis for promoting Good Regulatory Practices, networking and work-sharing, as well as transparency among NRAs.