Essential medicines and health products

WHO Expert Committee on Specifications for Pharmaceutical Preparations

TRS 981 - Forty-seventh report


Publication details

Number of pages: 202
Publication date: May 2013
Languages: English
ISBN: 978 92 4 120981 6


The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensusbuilding process.

The following new guidelines were adopted and recommended for use: Release procedure for International Chemical Reference Substances; WHO guidelines on quality risk management; WHO guidelines on variations to a prequalified product; and the Collaborative procedure between the World Health Organization Prequalification of Medicines Programme and national medicines regulatory authorities in the assessment and accelerated national registration of WHO‑prequalified pharmaceutical products.