Good Review Practices: Guidelines for National and Regional Regulatory Authorities. (WHO Drug Information Vol. 29, No. 1, 2015)
(2015; 6 pages)

Abstract

This is a summary of a guideline on good regulatory review practices developed through an inter-organizational collaboration. It 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).

The full text as adopted by the WHO Expert Committee on Specifications for Pharmaceutical Preparations in October 2014 will be published as an annex to the Expert Committee’s report; the draft published for comment prior to the Committee’s meeting is available on the WHO web site.

 
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