The concept of an SRA was developed by the WHO Secretariat and The Global Fund to Fight AIDS, Tuberculosis and Malaria in 2008. A regulatory authority provides the framework that supports the World Health Organization (WHO) recommended regulatory functions which oversee medical products in a country, ensuring quality, safety, efficacy, and accurate information.
WHO defines a SRA as a regulatory authority which is:
- a member of the International Council on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) (as specified on www.ich.org); or
- an ICH observer, i.e. the European Free Trade Association (EFTA), as represented by SwissMedic, and Health Canada (as may be updated from time to time); or
- a regulatory authority associated with an ICH member through a legally-binding, mutual recognition agreement including Australia, Iceland, Liechtenstein and Norway (as may be updated from time to time).
The concept is due to be replaced in the middle or long term by the concept of ‘World Health Organization listed authority’ (WLA). The WLA replaces the SRA definition where a WLA is a regulatory authority or a regional regulatory system that complies with all the relevant indicators and requirements specified by WHO for regulatory capability as defined by an established benchmarking and performance evaluation process.
The WLA framework offers a modular approach as a regulatory authority that can be designated for a specific regulatory function or a specific type of product. The SRA and WLA definitions differ by the designation mechanism; where the SRA definition is based on membership in the ICH as before October 2015, and the WLA framework offers a modern, transparent and evidence-based framework to identify trusted authorities and giving the opportunity to new regulatory authorities to be designated as WLA.
To be designated as WLA, a regulatory authority should undergo:
- a formal assessment with the WHO-Global Benchmarking Tool to demonstrate adequate maturity (Maturity Level 3 as entry point) and;
- a performance evaluation process that complements the results of benchmarking, confirming consistency of advanced performance against international standards and best practices.
Some transitional arrangements are in place for previously designated SRAs and regulatory authorities which had been previously assessed by WHO.