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

Overview

This report presents the findings, discussions and recommendations of the fifty-ninth meeting of the WHO Expert Committee on Specifications for Pharmaceutical Preparations, held in October 2025. It forms part of the WHO Technical Report Series and contributes to the Organization’s normative work in establishing international standards to ensure the quality, safety and efficacy of medicines. The report reflects WHO’s mandate to support Member States through evidence-based guidance addressing pharmaceutical quality assurance, regulatory frameworks and access to essential medical products.

The document summarizes technical updates and deliberations across a wide range of areas, including The International Pharmacopoeia, quality control specifications, international reference substances, and good manufacturing and inspection practices. It also addresses regulatory guidance, prequalification procedures, and measures related to distribution, supply chains and market surveillance. The report compiles adopted guidelines, revised texts and recommendations intended to strengthen regulatory systems, promote harmonization and support the global availability of safe, effective and quality-assured medicines.