UK Medicine Control Agency "Record Performance"

In its 1996/97 annual report, the UK's Medicines Control Agency said itachieved a "record performance" last year in the assessment of new drug substances, assessing 39 in a mean time of just 43 days. It assessed 99% of all applications for marketing authorizations within 100 days and handled a record number of variations and reclassifications.

One of the Agency's major initiatives, it says, was to establish an Inspection Unit last October to monitor and ensure compliance with Good Clinical Practice in the conduct of clinical trials. And effective April 1997, the UK Good Laboratory Practice Monitoring Authority became part of the MCA, having transferred from the Department of Health.

While pointing out that last year the MCA had reduced the license fee by 2%, and would not introduce an increase this year (for the fourth consecutive year), it was stated that in inviting pharmaceutical sponsor companies to request GCP inspections voluntarily, in anticipation of a European Union directive, the Agency would require a contribution to its costs.