WHO Expert Committee on Specifications for Pharmaceutical Preparations 57th Report

Detected March 13th, 2026

Summary

The WHO Expert Committee on Specifications for Pharmaceutical Preparations has released its 57th report, recommending new and revised guidance texts for pharmaceutical quality assurance. These include updated GMP for excipients, new GMP for radiopharmaceutical cold kits, revised lab quality control practices, and updated biowaiver guidelines.

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What changed

The 57th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations recommends several new and revised guidance documents aimed at ensuring the quality of medicines globally. Key updates include revised WHO good manufacturing practices (GMP) for excipients, a new IAEA/WHO GMP for in-house cold kits for radiopharmaceutical preparations, revised WHO good practices for pharmaceutical quality control laboratories, and updated guidelines on biopharmaceutics classification system-based biowaivers. The report also includes a republished guideline on registration requirements for multisource (generic) pharmaceutical products to establish interchangeability.

These recommendations are intended for implementation by pharmaceutical manufacturers and regulatory authorities worldwide. While the report itself does not specify a compliance deadline, the adoption and implementation of these standards are crucial for ensuring product quality, facilitating international trade of medicines, and supporting regulatory harmonization. Companies should review these updated guidelines to ensure their quality assurance systems and registration dossiers align with the latest WHO recommendations.

What to do next

Review updated WHO GMP for excipients
Review new IAEA/WHO GMP for radiopharmaceutical cold kits
Review revised WHO good practices for pharmaceutical quality control laboratories

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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 manufacturing practices for excipients used in pharmaceutical products (revision); IAEA/WHO good manufacturing practices for in-house cold kits for radiopharmaceutical preparations (new); WHO good practices for pharmaceutical quality control laboratories (revision); WHO/UNFPA female condom generic specification (new); WHO Biowaiver List: proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release (updated), solid oral dosage forms; WHO guideline on Biopharmaceutics Classification System-based biowaivers (revision); and Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability (republished). All of the above are included in this report and recommended for implementation.

WHO Team Access to Medicines and Health Products (MHP), Expert Committee on Specifications for Pharmaceutical Preparations, Health Product Policy and Standards (HPS), Norms and Standards for Pharmaceuticals (NSP), Technical Standards and Specifications (TSS) Number of pages 352 Reference numbers ISBN: 978-92-4-009103-0 Copyright