The World Health Organization (WHO) supports the implementation of reliance on other  regulators’ work as a general principle in order to make the best use of available resources and expertise.

This principle enables leveraging the output of others whenever possible while placing a greater focus  at the national level on value added regulatory activities that cannot be undertaken by other authorities,  such as, but not limited to, in-country vigilance and market surveillance and control activities and  oversight of local manufacturing and distribution. Reliance approaches facilitate timely access to safe, effective and quality-assured medical products (see 5. Scope) and can help in regulatory preparedness and response, particularly during public heath emergencies.

 Good Reliance Practices (GReIP) are anchored in the overarching Good Regulatory Practices (GRP) (1) which provide a means for establishing sound, affordable and effective regulatory oversight of medical products as an important part of health system strengthening. If implemented effectively, GRP can lead to consistent regulatory processes, sound regulatory decision-making, increased efficiency of regulatory systems and better public health outcomes. National regulatory authorities (NRAs) are encouraged to adopt these best practices in order to ensure that they are using the most efficient regulatory processes possible.

 An ongoing initiative at WHO aims at establishing and implementing a framework for evaluating regulatory authorities and designating them as WHO-Listed Authorities (WLAs) (2). Based on benchmarking using the WHO Global Benchmarking Tool (GBT) (3), along with a performance evaluation process, WHO will assess the regulatory authority’s performance and maturity level in order to qualify a regulatory authority as a WLA and thereby provide a globally recognized, evidence-based and transparent system that can be used by NRAs as a reference for the selection of reference regulatory authority(ies) to practice reliance. A list of reference regulatory authorities is available on the WHO Website for NRAs to refer to (4).