The NC3Rs has 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 review identified almost 350 separate instances where animal tests are recommended within WHO guidance documents. The NC3Rs has 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.
The following recommendations 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.
