Good review practices: guidelines for national and regional regulatory authorities
Background:
The good review practices (GRevP) guidelines for regulatory authorities emanate from a partnership between the Asia-Pacific Economic Cooperation (APEC) Regulatory Harmonization Steering Committee (RHSC) and the World Health Organization (WHO). This is the first set of guidelines of its kind globally and addresses an important gap identified at the 2012 International Conference of Drug Regulatory Authorities (ICDRA). Although the RHSC does not directly produce guidelines, contributing to WHO guidelines is in line with the RHSC’s principle of working with appropriate partners to achieve common objectives.
In June 2013 the RHSC convened an expert working group with WHO representation to develop a draft GRevP document, intended to cover both medicines and medical devices, for submission to WHO in early 2014. The draft document subsequently underwent the required WHO consultation process with a view to its further development into WHO guidelines for adoption by the Expert Committee on Specifications for Pharmaceutical Preparations and the Expert Committee on Biological Standardization. This led to thes new GRevP guidelines for regulatory authorities adopted by the WHO Expert Committee on Specifications for Pharmaceutical Preparations at its forty-ninth meeting.
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Table of contents
WHO TRS (Technical Report Series) 992, 2015 Annex 9:
