WHO TRS (Technical Report Series) 1033, 2021 Annex 10

WHO TRS (Technical Report Series) 1033, 2021 Annex 10

Good reliance practices in the regulation of medical products: high level principles and considerations


WHO supports reliance on the work of other regulators as a general principle in order to make the best use of available resources and expertise. This principle allows leveraging the output of others whenever possible while placing a greater focus at national level on value-added regulatory activities that cannot be undertaken by other authorities, such as, but not limited to: vigilance, market surveillance, and oversight of local manufacturing and distribution. Reliance facilitates timely access to safe, effective, quality-assured medical products (see section 3. Scope) and can support regulatory preparedness and response, particularly during public health emergencies.

Good reliance practices (GRelP) are anchored in overall good regulatory practices (GRP) (1), which provide a means for establishing sound, affordable, effective regulation of medical products as an important part of health system strengthening. If implemented effectively, GRP can result in consistent regulatory processes, sound regulatory decision-making, increased efficiency of regulatory systems and better public health outcomes. NRAs are encouraged to adopt GRP to ensure that they are using the most efficient regulatory processes possible.

WHO is establishing and implementing a framework for evaluating regulatory authorities and designating those that meet the requirements as “WHO-listed authorities” (WLA) (4). Using the WHO Global Benchmarking Tool (5) and performance evaluation, WHO will assess the maturity and performance of a regulatory authority to determine whether it meets the requirements of a WLA and thereby provide a globally recognized, evidence based, transparent system that can be used by NRAs as a basis for selecting reference regulatory authorities to practise reliance. A list of reference regulatory authorities is available on the WHO website (6).

In September 2019, WHO held a consultation to solicit input on the nature, structure and overall content of a document outlining GRelP. The meeting concluded that the concept note and recommendations on regulatory reliance principles of the Pan American Health Organization (PAHO) and the Pan American Network for Drug Regulatory Harmonization (7) should be used as a basis for the WHO document on GRelP. The high-level document would be complemented by a repository of case studies, practice guides and examples of practical application of GRelP.

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WHO TRS (Technical Report Series) 1033, 2021 Annex 10:

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