§ Mr. KennedyTo ask the Secretary of State for Health what steps he is taking to reduce the average time taken to grant product licences.
§ Mrs. Virginia BottomleyDuring the past year the Medicines Control Agency (MCA) has been reorganised into separate businesses, licensing procedures have been streamlined and additional professional staff have been allocated to licensing work. As a result there have been substantial improvements in the agency's performance.
The agency is justifiably proud of its' position as the fastest licensing authority in the world for new drug substances. It wishes to retain this position. The director of the Medicines Control Agency has recently reported that it has actively sought to improve its performance in this area over the past 12 months.
In the abridged (established drug substances) licensing area there has also been considerable progress. The time to reach a licensing decision on standard and complex applications has reduced from 16 months in September 1990 to 10 months in January 1991 and will be further reduced to four months by April 1992. For those applications which have to be submitted to a committee set up under section 4 of the Medicines Act 1968 the time taken has reduced from 19 months in September 1990 to 13 months in January this year and will be seven months by April 1992. These are net times and do not include the time industry may take, often significant, to respond to questions raised by the agency about their applications.
§ Mr. KennedyTo ask the Secretary of State for Health what is the average time taken to grant product licences for parallel imports.
§ Mrs. Virginia BottomleyDuring the seven months from 1 January 1990 to 31 July 1990, the latest period for which figures are available, the average time taken from date of application to date of grant of a parallel import licence was 18 months.