§ Mr. AmosTo ask the Secretary of State for Health how many drugs received product licences in the United Kingdom in the last year for which figures are available; and how long each took to receive its licence.
§ Mrs. Virginia BottomleyFor the 12 months ended 31 March 1991, the following medicinal products were granted product licences by the United Kingdom Licensing Authority:
Application type Numbers New Drugs 171 Established Drugs 657 Total 728 1 Involving 34 new active substances The term "Established Drugs" refers to those applications which are based on drugs already licensed in the United Kingdom. Information regarding the time taken for each application to reach a decision cannot be given for reasons of commercial confidentiality. The average time taken to reach decisions on the 728 licences granted during 1990–91 is:
Application type New drugs 19 months Established drugs 19 months if considered only by the licensing authority. 23 months if referred to a committee established under the Medicines Act 1968. These figures are gross times and include time taken by pharmaceutical companies to respond to enquiries made by the licensing authority and time taken for committee consideration and subsequent appeals to section 4 committees and the medicines commission, where necessary.
Licensing volumes and times are included in each edition of MAIL (the Medicines Act Information Letter), copies of which will be placed in the Library.