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Recommendations to integrate 3Rs approaches in WHO guidance for biological products

Needle in a vial of vaccine

We have published a report recommending opportunities for the wider adoption of 3Rs approaches within World Health Organisation (WHO) guidance documents for the quality, safety and efficacy of vaccines and biological therapeutics.

The report is the culmination of a three-year project to review animal testing requirements in WHO guidelines with the aim of reducing animal use and delays in the availability of life-saving products to those that need them most. The project was co-funded by the Bill and Melinda Gates Foundation and delivered with the support of an expert international working group.

The review identified almost 350 separate instances where animal tests are recommended within WHO guidance documents. We have developed alternative text for each of these instances with the 3Rs at the forefront, including encouraging the adoption of non-animal approaches where they have been demonstrated to be scientifically robust.  

In the report we make the following recommendations that were developed in collaboration with the global biologicals regulatory and manufacturing communities: 

  • Each product-specific guideline should be updated to include the new 3Rs text where animal tests are currently recommended.
  • The WHO should draft a position statement and guidance on the incorporation of 3Rs practices into quality control and batch release testing.
  • A separate manual should be drafted to support the adoption of 3Rs approaches specifically for endotoxin and pyrogenicity testing.
  • Changes should be made to the way WHO guidance documents are updated to improve their accessibility and utility. 

We have created an online resource to share the report and a searchable database of all animal tests identified through our review and the suggested alternative text we have recommended. Related project publications and recordings from our global stakeholder engagement workshops can also be found on a dedicated resource page. 

The report was well received by WHO’s Expert Committee on Biological Standardization (ECBS) at their October 2023 meeting, acknowledging “…the quality and comprehensiveness of the work undertaken during the review” and recommending “…that a working group be established to build upon its findings and to develop further WHO guidance in this area”. We are looking forward to supporting WHO in the implementation of our recommendations and working with the global biologicals community to continue to apply the 3Rs in vaccine development and testing. 

“Heartiest congratulations to the NC3Rs team and all the collaborators for having achieved this remarkable feat. This is really an exemplar of teamwork, good coordination and excellent driving force from the top in successfully bringing together various professionals from different countries across the globe and leading them together to attain its goal.”

Sunil Goel, Serum Institute of India.

“The presentation of the NC3Rs report to WHO/ECBS is a major step towards the international harmonization of quality control and lot release methods used for vaccines and biological therapeutics. The outcomes from this effort will assist many countries in accepting and adopting the use of non-animal test methods based on sound scientific principles.”

Richard Isbrucker, Health Canada.