Kent Woods

MHRA plans to cut red tape in the UK

pharmafile | March 13, 2012 | News story | Manufacturing and Production EU, MHRA, pharma 

The UK government’s drug safety regulator is calling on the pharma industry to help it eliminate unneccessary bureaucracy.

The Medicines and Healthcare products Regulatory Agency (MHRA) wants companies to suggest which existing regulations need to be modified, or discarded. 

Part of the government’s much-vaunted ‘red tape challenge’, respondents have five weeks to comment via the the Cabinet Office’s website.

The MHRA says more than 250 separate regulations impact on its work, and for this exercise they are broken down into: 

  • medicines
  • clinical trials
  • good laboratory practice
  • traditional herbal medicines
  • homeopathic medicines
  • blood
  • fees
  • pharmacy

MHRA chief executive Professor Sir Kent Woods, 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.”

Hot topics for responses so far online include clinical trial applications, with worries about a ‘one size fits all’ approach to approvals.

This is an area which has already attracted much debate, with medical researchers calling for the rules around trials in Europe to be stripped back to avoid stifling medical advances.

The MHRA says it will take comments into account when it goes through each regulation and decides what action should be taken. 

Its proposals will then be reviewed by a ministerial ‘star chamber’ which will have a remit to get rid of regulations which cannot be ‘strongly justified’ in a process which will take about three months.

However, many of the rules relating to the MHRA are derived directly from European Commission policy, which means they are unlikely in most cases to be unilaterally scrapped. 

But the government says of EU regulations: “There may still be scope to improve implementation and enable greater efficiency. 

“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,” said health minister Simon Burns. 

A separate government review into the regulation of medical devices – the MHRA’s other key area of influence – is ongoing, so devices will not undergo the ‘red tape challenge’ until later in 2012.

Adam Hill

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