MHRA wants to be a World-Class Regulator, Plans to Use Clinical Data to Assist HTA Assessments

Posted 12 April 2013 | By Alexander Gaffney, RAC 

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has announced a new set of lofty goals that it says will catapult the regulator to the top tier of those now on the "world stage."


Under a five-year corporate plan, MHRA said it would focus on five areas of improvement:

  1. the role of regulation and the regulator
  2. bringing innovation safely to market
  3. strengthening surveillance
  4. safe products and secure supply in globalized industries
  5. achieving excellence - a well-run, efficient and effective organization.

"This corporate plan reflects the MHRA's desire to lead regulatory matters globally and bring new innovative medicines and products safely to market," the regulator wrote in a statement.

Already the agency has seen some large-scale changes, having adopted two new departments--the National Institute for Biological Standards and Control (NISBC) and the Clinical Practice Research Datalink (CPRD)-under its control in the last two months. MHRA has also recently opened a new online "innovation center" to facilitate the regulatory process for manufacturers of innovative products.

The addition of these agencies and department to MHRA "is central to the strategic direction mapped out in this corporate plan," Sir Gordon Duff, chairman of MHRA, said in a statement.

Supporting Innovation…and HTA

MHRA also explained that it believed the plan would support the innovation of new medicines and medical devices. "We are committed to this, and the plan sets out our approaches to getting innovation into clinical use as quickly as is safely possible, to improving the oversight and vigilance of products once they are in use, and to protecting UK citizens from threats in the supply chains of the two highly globalized industries that we regulate," Duff added.

Part of that will involve a closer relationship between MHRA and health technology assessment (HTA) bodies such as the National Institute for Health and Care Excellence (NICE), which has the final word on whether products are suitable for reimbursement from the National Health Service (NHS). While MHRA said it did not envision having a role in conducting HTA itself, it said it recognized that data from its CPRD "had the potential to inform the work of HTA bodies as well as our own regulatory work."

"We are [looking] to improve the way in which our product regulation integrates with the roles of professional regulation and standards," it continued, adding later that it believed this same data could be used to develop more efficient clinical trials.

Leveraging Data

In other instances, MHRA said it wants to leverage more of its data, such as that obtained by the NIBSC, to "support the safe and effective development of biologics, a hugely important and growing class of medicines where opportunities are great but risks need to be managed very carefully."

As with US regulators, MHRA said it is interested in developing new regulatory approaches targeted at specific groups in the hopes of better assessing safety and effectiveness in narrow populations. This, it said, will allow it to better inform clinical practice and allow for earlier access to medicines.

"We see these developments as part of a wider strategic move to explore whether targeted adjustments to the boundaries between pre- and post- marketing work may benefit patients, while ensuring that their safety is robustly safeguarded," it said.

Also scheduled to be developed: A system capable of analyzing real-time benefit:risk data, part of a new focus on postmarketing safety aimed at allowing it to identify problems more quickly.

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