Changes to clinical trial regs come into force in UK next month

The Medicines for Human Use (Clinical Trials) Amendment Regulations, laid in the UK Parliament on 20 July 2006, will come into force on 29 August 2006. The changes principally implement Commission Directive 2005/28/EC1 (the Good Clinical Practice (GCP) Directive) by amending the Clinical Trials Regulations, which implement the Clinical Trials Directive.

The provisions implementing the GCP Directive relate to: sponsor's delegation of functions; content and presentation of the investigator's brochure; qualifications and procedures for inspectors; retention of documents and archiving; sharing of information between ethics committees and the licensing authority; scope of manufacturing authorisations and procedures for their holders; and wording of principles of Good Clinical Practice.

The Amendment Regulations also include additional changes to the Clinical Trials Regulations, which do not arise out of the GCP Directive. These additional provisions relate to arrangements for payment of fees; notifying the licensing authority of serious breaches of GCP and/or the protocol; and the extension of the infringement notices (warning notices) regime.

The Amendment Regulations also correct various minor errors in the Clinical Trials Regulations.

For further information contact the Clinical Trials Unit, 12-2, MHRA, Market Towers, 1 Nine Elms Lane, London SW8 5NQ,UK. T +44 0207 084 2327.