§ Sir Michael McNair-WilsonTo ask the Secretary, of State for Health (1) for how long the Committee on Safety of Medicines has been considering the licensing of erythropoetin; what is the average length of time the committee takes to license a new drug; and how many drugs are before the committee awaiting a licence;
(2) pursuant to his answer of 8 February, Official Report, column 772, what additional information and data are being sought about erythropoetin from the manufacturers by the Committee on Safety of Medicines relating to its safety, quality and efficacy; and on what specific matters reassurance is being sought.
§ Mrs. Virginia BottomleyThe licensing authority is responsible for issuing licences and routinely seeks the advice of the Committee on Safety of Medicines in respect of all drugs containing new active substances. The average gross processing time taken to license drugs of this kind (including the time taken by the company to answer inquiries) in the 12-month period ending 30 September 1989 was 19 months. There are currently 20 applications under consideration. For reasons of commercial confidentiality it is not our practice to disclose details of individual applications. I can say, however, that matters relating to erythropoetin licensing have been considered recently by the European Community's committee for proprietary medicinal products whose response is awaited.