§ Mr. CoxTo ask the Secretary of State for Social Services what is the policy of his Department and appropriate committees on the granting of licences or provisional licences for drugs and therapies when full licences have already been granted by well-recognised national organisations, such as the United States Food and Drugs Authority; what priority the Committee on Safety of Medicines gives to consideration of such drugs and therapies when there are no known alternative cures; and if he will make a statement.
§ Mr. NewtonUnder the Medicines Act 1968 and EC directives the United Kingdom licensing authority must be satisfied as to the safety, quality and efficacy of a medicinal product for human use before granting a product licence. In making a decision, the licensing authority must consider for itself the evidence which the directives require the applicant to submit, and also takes account of other relevant information which may include licensing decisions by other national regulatory agencies.
Licence applications are normally assessed in strict chronological order of receipt. Exceptionally, a product licence application may be fast-tracked when there are compelling reasons for believing that the product would provide a major therapeutic breakthrough in the treatment of patients for indicated conditions. "Fast tracking" means that the application is considered out of turn; it does not mean that normal standards are lowered.