|Date:||Friday 15 November|
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In a report published today by the Medicines and Healthcare Products Regulatory Agency, the Expert Group on Innovation in the Regulation of Healthcare has called for greater uptake of existing legal flexibilities to accelerate patient access to innovative medicines to address areas of unmet medical need. Establishment of the Group was one of the key commitments of the Prime Minister’s 2011 Strategy for UK Life Sciences.
A key recommendation of the Expert Group is tasking the MHRA to press the European Medicines Agency (EMA) to launch a call for adaptive licensing at the earliest opportunity, so that companies can put forward pilot products to use these flexibilities.
The Expert Group supports the proposed UK early access scheme for unlicensed medicines and urges the government to launch the scheme as soon as possible. The Expert Group recommends that the government consider accommodating within the scheme a designation that a product was a potential candidate for the early access scheme.
As part of the ongoing commitment to encourage innovation the MHRA Innovation Office - which was set up in March 2013 - will continue to be available to help organisations who are developing innovative medicines, medical devices or using novel manufacturing processes to navigate the regulatory processes in order to be able to progress their products or technologies. In addition, the agency offers a scientific advice service to advise applicants in the design of their development programmes.
The agency‘s Chief Executive, Dr Ian Hudson said:
“The MHRA is committed to play its part in creating an environment that will encourage innovation and help patients get faster access to new, innovative medicines and treatments.
“We want to see improvement in the health of millions of people. There are a range of regulatory tools that can be appropriately used to allow innovative products to be developed in an optimal way for the benefit of public health. Organisations developing innovative products can come to us as a one stop shop for scientific legal and regulatory advice.
“The report is now being considered by Ministers at the Department of Health and the Department for Business, Innovation and Skills.”
Notes to Editor1. Please see link to the MHRA’s Innovation Office.
2. The Expert Group on innovation in the regulation of healthcare was established in June 2012 following the Prime Minister’s 2011 Strategy for UK Life Sciences.
3. Please see the Expert Group report
4. The centralised flexibilities include:
• full approval
• approval with conditions (this is where approval includes obligations on the marketing authorisation holder to conduct post-authorisation studies on safety and on efficacy)
• conditional approval (granted when in order to meet unmet medical needs of patients and in the interest of public health, it may be necessary to grant marketing authorisations on the basis of less complete data than is normally required)
• approval under exceptional circumstances (where the applicant must demonstrate that they are unable to provide comprehensive data on the safety and efficacy under normal conditions of use).
• Accelerated assessment can be initiated by CHMP on public health grounds which reduces the timetable from 210 to 150 days.
5. The MHRA consulted in 2012 (reference MLX 376) on proposals for a UK scheme that would provide a scientific opinion on the benefits and risks of certain promising new medicines to treat, diagnose or prevent life threatening conditions without adequate treatment options before licensing. This is known as the Earlier Access to Medicines Scheme. The MHRA would undertake a scientific review of data supplied by a company and if, based on that review, the MHRA considers that the benefits of the medicine are likely to outweigh the risks, an opinion to that effect will be provided.
6. The Medicines and Healthcare Products Regulatory Agency is responsible for protecting and improving the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research. The Agency consists of three centres: the Clinical Practice Research Datalink (CPRD), the National Institute for Biological Standards and Control (NIBSC) and the MHRA.
7. The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. Underpinning all its work lies robust and fact-based judgements to ensure that the benefits justify any risks.
8. The European Medicines Agency (EMA) is an agency of the European Union (EU) responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the EU. In order to obtain a medicines licence (marketing authorisation) for an innovative product, an application must be made to the EMA under the centralised procedure. The assessment of products is shared between national medicines regulatory agencies, including the MHRA. The MHRA also issues clinical trial authorisations for trials taking place in the UK. The MHRA can provide scientific advice throughout the drug development process.