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Drugs: Testing

Volume 505: debated on Friday 5 February 2010

To ask the Secretary of State for Health what research his Department has evaluated on the comparative (a) safety and (b) effectiveness of (i) human biology-based testing and (ii) animal testing of new drugs and treatments. (316006)

The Medicines and Healthcare products Regulatory Agency (MHRA) is the competent authority responsible for the issuing on Marketing Authorisations (licences) and assessing Clinical Trial Applications for medicinal products and devices.

The MHRA has not directly evaluated any specific studies on the comparative safety and effectiveness of human biology testing and animal testing of new drugs and treatment. The MHRA has, however, been indirectly involved in a number of initiatives in this field that are actively evaluating the replacement of whole animal studies with suitable alternatives, including the use of human tissue samples. Today’s approaches to drug development, involving an integrated programme of non-clinical testing and clinical trials, have been built up on a rational and scientific basis for more than 30 years. At present there are no validated and established laboratory methods available to totally replace animal testing of medicinal products.