§ Mr. HinchliffeTo ask the Secretary of State for Health what independent monitoring or evaluation of the data submitted by general practitioners and hospital doctors concerning the testing of new drugs is carried out by his Department's Committee on Safety of Medicines prior to the licensing of such drugs.
§ Mrs. Virginia BottomleyA company is required to certify the accuracy of all the results from clinical trial data, submitted in support of a product licence application for a new drug. The Committee on Safety of Medicines, comprising eminent experts in the fields of medicine, science and pharmacy, carefully evaluates these data and has to be satisfied as to the safety, quality and efficacy of the drug in question before advising the Licensing Authority on whether or not a product licence should be granted.
Published guidelines require companies to establish procedures for the organisation, conduct, documentation and verification of clinical trials, and for the audit and archiving of clinical trial data.