- Todos > Quality and Safety: Medicines > Quality Assurance
- Todos > Quality and Safety: Medicines > Regulatory Support
- Palabras clave > Good Regulatory Practice (GRP)
- Palabras clave > Good Review Practices (GRevP) - regulatory authorities
- Palabras clave > International Conference of Drug Regulatory Authorities (ICDRA)
- Palabras clave > quality - management system
- Palabras clave > quality control
- Palabras clave > quality management system (QMS) for NRA/NCL
- Palabras clave > Quality Risk Management (QRM)
- Palabras clave > Standards Operating Procedures (SOP)
- Palabras clave > WHO expert committee
(2015; 20 pages)
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 these new GRevP guidelines for regulatory authorities adopted by the WHO Expert Committee on Specifications for Pharmaceutical Preparations at its forty-ninth meeting.
The objective of this 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.
This document is envisioned as one building block in a set of tools and is sufficiently expandable to accommodate additional annexes or ancillary documents in the future.