Changeflow GovPing Pharma Standards WHO Expert Committee on Biological Standardizat...
Routine Guidance Added Final

WHO Expert Committee on Biological Standardization Eightieth Report

Favicon for www.who.int WHO Pharmaceutical Standards
Published October 11th, 2024
Detected March 13th, 2026
Email

Summary

The World Health Organization has published the eightieth report of its Expert Committee on Biological Standardization. This report details the proceedings and recommendations from the committee's meeting held in October 2024, focusing on the norms and standards for biological products.

What changed

The World Health Organization (WHO) has released the eightieth report from its Expert Committee on Biological Standardization. This document, published following the committee's hybrid meeting in Geneva from October 7-11, 2024, outlines updated recommendations and discussions concerning the standardization of biological products. The report covers a range of topics relevant to the development, quality, and regulation of vaccines, therapeutics, and other biological agents.

This report serves as guidance for manufacturers and regulatory bodies involved in biological product development and oversight. While it does not impose immediate binding obligations, adherence to its recommendations is crucial for ensuring product quality, safety, and international harmonization. Compliance officers should review the report for any implications on product development pipelines, quality control measures, and regulatory submission strategies, particularly concerning evolving international standards.

What to do next

  1. Review the WHO Expert Committee on Biological Standardization's eightieth report for implications on product development and quality control.
  2. Assess current practices against the report's recommendations for biological product standardization.
  3. Incorporate relevant international standards into regulatory and quality assurance strategies.

Source document (simplified)

  • Select language - العربية 中文 français русский español português

Download (1.2 MB)

Overview

Eightieth meeting held using a hybrid format in which Committee members and the WHO Secretariat met in person in Geneva from 7 to 11 October 2024 with other participants attending virtually. WHO Team Health Product Policy and Standards (HPS), Norms and Standards for Biological Products (NSB) Editors World Health Organization Number of pages 298 Reference numbers ISBN: 9789240111011 Copyright

Classification

Agency
Various
Published
October 11th, 2024
Instrument
Guidance
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Drug manufacturers Pharmaceutical companies Medical device makers
Geographic scope
International

Taxonomy

Primary area
Public Health
Operational domain
Compliance
Topics
Biological Products Standardization Regulatory Policy

Get Pharma Standards alerts

Weekly digest. AI-summarized, no noise.

Free. Unsubscribe anytime.

Get alerts for this source

We'll email you when WHO Pharmaceutical Standards publishes new changes.

Free. Unsubscribe anytime.