EMA - Activities to reduce the Use of Animal Testing

Recommendation

9/10 May 2023
Heidelberg, Germany

Annex 2 & Co. - GMP Compliance for Biopharmaceuticals
Regulatory Requirements and Practical Implementation

In some cases - e.g. the classical pyrogen testing, the so called "rabbit test" - animal tests have been traditionally used. In accordance with the Directive 2010/63/EU on the protection of animals used for scientific purposes (from 3 June 2010) and in line with other associated relevant guidelines, the EMA as well as the member states of the European Union try to replace animal tests by new methods. They follow the principle of the 3Rs (Replacement, Reduction and Refinement) selecting approaches for validating quality control tests in laboratories for regulatory testing of human and veterinary medicinal products.

Now the EMA published a Draft "Guidance for individual laboratories for transfer of quality control methods validated in collaborative trials with a view to implementing 3Rs" for public consultation until 31 January 2017. This guidance aims to facilitate transfer of the new methods validated in such trials with a view to implementing 3Rs for testing in a product specific context in laboratories originally involved in the collaborative trial or in new laboratories. The document should be helpful in supporting regulatory applications for variations to existing marketing authorisations as well as new applications.

The draft document includes the following items:

1. Introduction (background
2. Scope
3. Legal basis
4. General features of a collaborative study and its role in method validation
5. Validation of 3Rs methods for regulatory acceptance
6. Transferring collaborative study validated methods to specific products/laboratories References

The activities to reduce animal testing are shown in other documents too. One example is the implementation of alternative test method in the European Pharmacopoeia (Ph. Eur.) - EDQM announces revision of general chapter Monocyte Activation Test (2.6.30) .

To get more detailed information or for commenting, please also see the "Guidance for individual laboratories for transfer of quality control methods validated in collaborative trials with a view to implementing 3Rs".