EMA mulls easing labs' adoption of in vivo batch test alternatives

How should labs validate alternatives to animal batch release tests?

Labs involved in EU-wide assessments of animal-free alternatives to drug quality and batch tests may soon be able leverage their work when seeking clearance to offer such methods as a service.

The European Medicines Agency (EMA) mooted a revision of the test validation rules last week.

The agency explained that before a new quality control method can be included in an EU monograph - including alternatives to animal testing - its scientific rigour must be assessed in large-scale collaborative trials often involving laboratories across the continent.

The problem is that after a test is accepted, individual labs must check the method works for each drug, which is a requirement that may be delaying “the implementation of methods that have the potential to replace, reduce and refine routine in vivo tests” according to the EMA.

In practice, laboratories that participate in large collaborative studies that lead to the inclusion of methods in regulatory texts will gain valuable experience with the method. It should be possible to take advantage of this experience in order to facilitate the process of gaining laboratory and product specific validation.

It should also be possible to benefit from the ground work laid in the collaborative study to facilitate implementation of the method in other laboratories.”

Guidance in 2015

To facilitate this various EMA working groups – including the JEG 3Rs, the BWP and the IWP – have teamed up to develop guidelines “that will clarify the level of  validation that will be required for individual medicinal products and laboratories wishing to use quality control tests that have already been validated in a large collaborative study.

Such a guideline will have relevance both for medicinal products under development and for medicinal products already on the market.”

The EMA is seeking comment from industry stakeholders, preclinical research laboratories and the general public by October 31. The agency anticipates the publication of a draft document in Q3 or Q4 in 2015.

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