WHO Expert Committee on Specifications for Pharmaceutical Preparations: fifty-eight report

Overview

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines and provision of global regulatory tools. The Expert Committee develops standards through worldwide consultation and an international consensus-building process. The following new guidance texts were adopted and recommended for use:

WHO good practice considerations for the prevention and control of nitrosamines in pharmaceutical products; WHO good manufacturing practices for excipients used in pharmaceutical products; Good practice guidelines for blood establishments; WHO Biowaiver List: proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms; Guideline on bioanalytical method validation and study sample analysis; Good practices of national regulatory authorities in implementing the collaborative registration procedures for medical products; Collaborative registration procedure between WHO and national regulatory authorities in the assessment and accelerated national registration of WHO-prequalified vector control products; Guidance for the graphic representation of chemical structures of pharmaceutical substances in the publications of international nonproprietary names and The International Pharmacopoeia. All of the above are included in this report and recommended for implementation.