Activities

FDAAA Contributes to WHO Guideline on Good Regulatory Review of Practices

By Florence Houn, MD

In 2015 World Health Organization (WHO) Expert Committee on Specifications for Pharmaceutical Preparations published its forty-ninth report, Annex 9, Good Review Practices: Guidelines for National and Regional Regulatory Authorities.

http://apps.who.int/medicinedocs/documents/s21902en/s21902en.pdf

This remarkable document contains the distilled wisdom of many regulators, experts, and the FDA Alumni Association (FDAAA). It is a simple primer for consideration by regulatory health authorities regarding the principles of good review practices (GRevP); management of the review, communications before, during and after review; review personnel; and the conduct of regulatory reviews of medical product applications.

The objective of the document is to provide high-level guidance on the principles and processes of good review practice (GRevP) for use across a range of regulatory authority (RA) maturities. It is not intended to provide detailed instruction on how to conduct a scientific review.

The effort began in June 2013 when the Asia-Pacific Economic Cooperation (APEC) Regulatory Harmonization Steering Committee (RHSC) convened an expert working group, with WHO representation, to develop a draft good review practices document, intended to cover both medicines and medical devices, for submission to WHO in early 2014. The GRevP Working Group Members representing the regulatory authorities from Australia, Canada, Taipei (China), Japan, Republic of Korea, Saudi Arabia, Singapore, and U.S., plus representatives of the Centre for Innovation in Regulatory Science (CIRS),.

The Food and Drug Administration Alumni Association was represented by Drs. Florence Houn and Jinjie Hu.

The document underwent the WHO consultative process in 2014, with comments sent back from WHO to the GRevP Working Group. Final submission back to WHO was in the Fall of 2014. This led to the Annex 9 GRevP Guidelines for Regulatory Authorities adopted by the WHO Expert Committee on Specifications for Pharmaceutical Preparations at its forty-ninth meeting.

FDAAA has been active in APEC in training programs for member economies and remains represented on the APEC Harmonization Center's Advisory Board based on Seoul, Korea. Through the activities of the FDAAA International Network, a subcommittee of the Activities Committee that serves to meet the FDAAA mission of providing technical assistance and consultation on regulatory programs especially in developing and emerging economies, FDAAA members can continue contributing to global health beyond their public health work when they were at FDA.