Over-arching: Good Review Practice Guide

Over-arching: Good Review Practice Guide

This guide is intended to provide guidance to applicants on Good Review Practices. It represents the South African Health Products Regulatory Authority’s current thinking on the safety, quality and efficacy of medicines and the safety, quality and performance of medical devices. It is not intended as an exclusive approach. Good review practices (GRevPs) are considered as ways to improve the Authority performance and ensure the quality of the regulatory system. The goal of GRevPs is to promote the timeliness, predictability, consistency, transparency, clarity, efficiency, and high quality of the content and management of reviews and review reports for pharmaceuticals.

Date uploaded

2022 Jun

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File Type: pdf
Category: Communication to industry, Guide
Unit: Corporate, General ECTD & human medicines