Cutting the Red Tape of Clinical Trial Regulations

The regulations and guidelines governing Clinical Trials in the UK can often be extremely complicated and over-burdensome, according to the Medicines and Healthcare Regulatory Agency (MHRA). For five weeks, from 9th March 2012 to 12th April 2012, the MHRA are asking for views and comments on this issue from Industry business professionals and members of the public.

It seeks to get feedback on questions such as “which of the regulations which govern the work of the MHRA should be kept, but also which could be simplified or even scrapped altogether!”

The MHRA are asking for input as part of the UK Government’s “Red Tape Challenge”, launched on 7th April 2011 by David Cameron, which aims to give business and the public the chance to feedback on more than 10,000 regulations. The aim of the challenge is to cut any unnecessary, and what is often seen as over complicated or burdensome, regulations across a whole range of sections. It seeks to identify if the existing regulations are actually providing the protection that is intended, or getting lost in the complexity.

The 250 regulations that the MHRA work to have been divided into the following 8 sub-categories; Medicine; Clinical Trials; Good Laboratory Practice; Blood; Pharmacy; Fees; Traditional Herbal Medicine; and Homeopathic Medicine. The MHRA want feedback from businesses on their thoughts on the current legislation and how these could be improved.

Professor Sir Kent Woods, the MHRA’s chief executive said, “Regulations are hugely important to the work that we do but we want to ensure we can carry out our work in the least burdensome way possible whilst ensuring patients are protected.”

Comments can be submitted on the Red Tape Challenge website: http://www.redtapechallenge.cabinetoffice.gov.uk/medicines-clinical-trials/