§ Mrs. Renée Short
asked the Secretary of State for Social Services what proposals he has received from the 511W working party under Professor Grahame-Smith to modify the guidelines in which the Committee on Safety of Medicines lays down the tests drug companies must perform on new drugs; when he expects to be able to make a decision about this; and if he will make a statement.
§ Dr. Vaughan
The working party chaired by Professor Grahame-Smith has reported to the Committee on Safety of Medicines on data requirements for clinical trial certificates, which has recently passed on its recommendations to the licensing authority. The licensing authority is considering the committee's recommendations and will shortly be consulting interested organisations on its proposals for modifying the present guidelines on data requirements. I will arrange for a copy of the licensing authority's consultative letter to be placed in the Library in due course.