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UK looks to ‘streamline’ medicines regulation

MHRA is taking part in the government's Red Tape Challenge

The UK's medicines regulator is looking for ways to cut down on unnecessary regulations in areas like clinical trials and good laboratory practice.

Over the next five weeks, the Medicine and Healthcare products Regulatory Agency (MHRA) is taking part in the government's Red Tape Challenge, and wants businesses and individuals to suggest which existing regulations should be kept and which should either be simplified or scrapped altogether.

Professor Sir Kent Woods, chief executive of the MHRA, 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.

“The Red Tape Challenge is an opportunity to seek views on these regulations to ensure we can work in the most efficient way possible whilst continuing to keep patient safety at the heart of everything that we do.”

There are more than 250 separate regulations that impact on the work of the MHRA but, the regulator said in a statement, even these are EU derived “there may still be scope to improve implementation and enable greater efficiency”.

Health minister Simon Burns said: "We are committed to removing excessive burdens and reducing bureaucracy where we can, whilst making sure that patient safety is never compromised.

"This Challenge will give those working in industry and clinicians a vital opportunity to let us know how we can improve the way we regulate or how we can do things differently, whilst ensuring the public is protected.”

The project forms the medicine's strand of the government's Red Tape Challenge and ideas can be submitted through the project's website or via email.

The project will cover medicines, clinical trials, good laboratory practice, blood, pharmacy, fees, traditional herbal medicines and homeopathic medicine.

When its first phase closes on April 12, the MHRA will have to consider every submission and decide what action needs to be taken.

Ministers will then review their proposals and go through the regulations with, the MHRA said, “the presumption that they will go unless they can be strongly justified”. The process is expected to take about three months.

A separate government review of medical devices' regulation is planned for later in the year, but has yet to be timetabled.

Meanwhile, in the autumn a further Red Tape Challenge will cover the remainder of Department of Health regulation that impacts on business, such as the cost of medicines, voluntary organisation or the citizen, but excluding the NHS.

12th March 2012


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