UK Medicines Control Agency Report For 1995-96

During 1995-96, the UK Medicines Control Agency established itself as the premier rapporteur in the European Union centralized drug licensing system and the leading reference member state in the decentralized system, David Jefferys, MCA board member for licensing, writes in the Agency's report for 1995-96.

Also in the report, MCA chief executive Keith Jones says that the Agency further reduced the mean assessment time for new active substance applications to 51 days, despite its reduced staff complement, and that all backlogs in the abridged licensing area have now been eliminated.

Dr Jefferys reports that the licensing division handled a record number of applications that were of increasing complexity, and assessed 831 abridged applications, up 21.5% on 1994-95. 75 were referred to the Committee on Safety of Medicines for advice. 47 new active substances were assessed in a mean time of 51 days, compared to 46 substances in a mean time of 56 days in 1994-95.