News

Updated MHRA risk-adapted approaches guidance: now published

NETSCC news Item 15 December 2011

The Medicines and Healthcare products Regulatory Agency (MHRA) has now published an update of its guidance on ‘risk-adapted approaches to the management of clinical trials of investigational products’. A copy of the updated guidance can be downloaded from: www.mhra.gov.uk/home/groups/l-ctu/documents/websiteresources/con111784.pdf 

The draft guidance has been improved following a NETSCC pilot carried out earlier this year to help researchers conduct and deliver non-commercial trials, and help reduce some of the current issues they are faced with.

We are pleased to have helped with the development of this important piece of work. NETSCC intend to remain involved with further developments relating to this work and will issue further updates as the work progresses.

For more advice on submitting a notification for a trial, please visit the MHRA website.