The Expert Committee on Specifications for Pharmaceutical Preparations works toward 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 consensus-building process. The following new guidelines were adopted and recommended for use:
WHO guidelines for selecting marker substances of herbal origin for quality control of herbal medicines
The International Pharmacopoeia: revised concepts and future perspectives
Prequalification of quality control laboratories
Procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies
WHO Global Model Regulatory Framework for Medical Devices including in vitro diagnostic medical devices
General background notes on the list of international comparator pharmaceutical products
Equilibrium solubility experiments for the purpose of classification of active pharmaceutical ingredients according to the Biopharmaceutics Classification System as an appendix to the WHO guideline on Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability (Annex 7, WHO Technical Report Series 992, 2015)