WHO Expert Committee Adopts New Pharmaceutical Guidance

Detected March 13th, 2026

Summary

The WHO Expert Committee on Specifications for Pharmaceutical Preparations has adopted nine new guidance texts aimed at ensuring the quality assurance of medicines. These texts cover areas such as nitrosamine prevention, good manufacturing practices for excipients, and bioequivalence assessments, and are recommended for implementation.

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What changed

The World Health Organization's Expert Committee on Specifications for Pharmaceutical Preparations has adopted nine new guidance documents, detailed in their fifty-eighth report. These texts provide updated standards and practical tools for the quality assurance of medicines globally. Key areas covered include good practice considerations for preventing and controlling nitrosamines in pharmaceutical products, good manufacturing practices for excipients, guidelines for blood establishments, and updated approaches to bioequivalence requirements and bioanalytical method validation.

These guidance texts are recommended for implementation by national regulatory authorities and pharmaceutical manufacturers. While the document does not specify a compliance deadline, the adoption of these texts implies a need for regulated entities to review and align their practices with these international standards to ensure product quality and facilitate global regulatory harmonization. The guidance aims to provide a consensus-based framework for the development and assessment of pharmaceutical products.

What to do next

Review the nine new WHO guidance texts on pharmaceutical quality assurance.
Assess current practices against the adopted guidance, particularly concerning nitrosamine control, GMP for excipients, and bioequivalence.
Implement necessary changes to align with international standards and recommendations.

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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 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.

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) Editors World Health Organizatio Number of pages 562 Reference numbers ISBN: 978-92-4-010826-4 Copyright