Evidence map›Paper›PMID 41075385›Full record

ArticleBiologicals : journal of the International Association of Biological Standardization2025

Conference report WHO informal consultation on the draft WHO Guideline on the phasing out of animal tests for the quality control of biological products.

Ian Feavers, Dianliang Lei, Catherine Milne, Ivana Knezevic, Tiequn Zhou, Eunkyung Kim

Abstract read
In one paragraph

Article in Biologicals : journal of the International Association of Biological Standardization, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Ian Feavers, Nacton, Suffolk, UK.
Dianliang LeiUnit of Technical Specifications and Standards, Department of Health Product Policy and Standards, Division of Access to Medicines and Health Products, World Health Organization, Geneva, Switzerland. Electronic address: leid@who.int.
Catherine MilneEuropean Directorate for the Quality of Medicines and HealthCare (EDQM), Council of Europe, Strasbourg, France.
Ivana KnezevicUnit of Technical Specifications and Standards, Department of Health Product Policy and Standards, Division of Access to Medicines and Health Products, World Health Organization, Geneva, Switzerland.
Tiequn ZhouUnit of Technical Specifications and Standards, Department of Health Product Policy and Standards, Division of Access to Medicines and Health Products, World Health Organization, Geneva, Switzerland.
Eunkyung KimUnit of Technical Specifications and Standards, Department of Health Product Policy and Standards, Division of Access to Medicines and Health Products, World Health Organization, Geneva, Switzerland.

Funding

World Health Organization 001
6 · The paper itself

Abstract

Animal testing has long supported the development and quality control of biotherapeutics and vaccines by ensuring safety and efficacy. However, its variability and time-consuming nature can delay product availability. Advances in non-animal technologies, guided by the 3Rs principles, have led to more efficient and scientifically robust alternatives. Recognizing the limitations of animal assays, WHO encourages their replacement when scientifically justified and has drafted a Guideline on phasing out animal tests in biological product quality control. Following public consultation, an informal meeting at WHO Headquarters brought together regulators, industry representatives, and other stakeholders to review the draft. The Guideline was developed based on ECBS recommendations and a review of existing WHO documents. Participants proposed improvements, including a revised title, to better emphasize the scientific rationale for replacing animal-based tests used in quality control scheme. These updates aim to support finalization of the document for a second public consultation and ECBS adoption.

Indexed as

Animal Testing AlternativesBiological ProductsGuidelines as TopicWorld Health OrganizationAnimalsHumansQuality ControlBiological ProductsAnimal testBiological productsQuality controlRemovalReplacementWHO Guideline

Identifiers

PMID41075385
PMCPMC12720286

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.