European Medicines Agency launches consultation on its position on replacement of animal studies

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12/04/2011

European Medicines Agency launches consultation on its position on replacement of animal studies

The European Medicines Agency has launched a public consultation on the need to revise its position on the replacement of animal studies with alternative models.

The concept paper on the need for revision of the position on the replacement of animal studies by in-vitro models, published this week, discusses the need to update the Agency's 1997 position paper on the feasibility of replacing methods using animals during the development of medicines.

The Agency is considering updating its position, because the past few years have seen a shift towards greater acceptance of in-vitro methods by medicines regulators. Focus has also broadened from an emphasis on the replacement of animal testing to the inclusion of all three 'R's: replacement, reduction and refinement.

The concept paper was prepared by the Safety Working Party and adopted by the Committee for Medicinal Products for Human Use (CHMP). It is open for consultation until 30 June 2011.

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Contact point:

swp-h@ema.europa.eu