UK'S MHRA AMENDS CLINICAL TRIALS REGULATIONS

The UK's Medicines and Healthcare Regulatory Products Agency (MHRA) has amended its Medicines for Human Use Regulations Good Clinical Practice (GCP) Directive. The amendment will go into effect Aug. 29.

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 authorizations and procedures for their holders; and wording of principles of good clinical practice.

The amended regulations also include additional changes to the Clinical Trials Regulations, which are not part 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 protocol; and the extension of the infringement notices (warning notices) regime. The amendments also correct various minor errors in the Clinical Trials Regulations.