Medical animal testing on regulator’s hit list
EMA is driving the move away from medical animal testing in the pharmaceutical and biologics industries.
The EMA’s two committees, the Committee for Medicinal Products for Human Use (CHMP) and the Committee for Medicinal Products for Veterinary Use (CVMP), are lobbying for the implementation of the 3R principles – Replace, Reduce and Refine. These principles aim to replace and minimize the amount animal testing where possible and refine practices when these assays need to be conducted so stress on animals is mitigated.
2017 saw the adoption of two guidance papers from the committees, one dedicated to supporting laboratories transfer 3R friendly methods validated in collaborative trials over to new product specific contexts.
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Also, the CVMP published a statement clarifying external regions supplying medicines or control tests for batch release to the EU must to conform to 3R principles.
This year will see two final reflection papers published aimed at preventing the use of unnecessary animal testing methods. The guidance highlights opportunities to limit animal testing and new methods that may become accessible in the future.
Until adequate alternatives are developed, testing on live animals for new medicines is, unfortunately, necessary to protect human health in some cases.
EU legislation commands the 3R standards are used by marketing authorization holders when these tests are needed to develop pharmaceuticals and biologics.
Studies from the National Center for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) determined that the welfare of animals can impact scientific outcomes and their ability to be indicative to human models. For example, the way mice are handled has significant impacts on their cognitive state and therefore their responses to behavioral tests.
Animal testing has long played a key role in the development of drugs and the medical understanding of how diseases work. However, animal models also have critical translation issues when results are compared to human trials.
In regards to preventing late stage failure, Dr David Hay, principal investigator at the University of Edinburgh’s MRC Centre for Regenerative Medicine argues that generating accurate data from animal models and extrapolating these findings so that they are relevant to human biology remains an area fraught with challenges.
A raft of organizations are conducting research into in-vitro and in-silico technologies – which seek to significantly minimize the use of animals in drug testing. A future in which drug discovery is far less reliant on animal testing may be on the horizon.
In its report the EMA promised that despite the hurdles ahead, Brexit and the move of its headquarters, the spread of the 3R principles into medical research will still be a key focus.