Posted 21 April 2017
By Zachary Brennan
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Friday released a business plan for the upcoming year, noting its primary focus on developing a consensus around a proposed model for the future of the country’s regulation of medicines and medical devices following its departure from the EU.
MHRA is pushing for a more international strategy that focuses on collaboration and engagement with key partners and stakeholders and continuing to participate in EU systems as much as possible, particularly to support earlier access to innovative products, for example through the Priority Medicines scheme (PRIME) and adaptive pathways.
The regulator adds that it needs to further figure out its "future relationship and engagement with our European counterparts in a post-Brexit context, including the potential for ongoing co-operation in EU regulatory procedures."
On the clinical trial front, MHRA notes that a key part of the transition to a regulatory framework outside the EU will be to ensure that the UK remains a top destination for science and innovation, acknowledging that the UK "applied sustained pressure to successfully reform the current Clinical Trials Directive in the best interests of enabling new treatments to be developed for the benefit of patients and we will continue to work with EMA, Member States and the Commission to prepare for implementation of the Clinical Trials Regulation."
In terms of what’s upcoming, the regulator is looking to establish a regular engagement forum with academic and research organizations by the end of the first quarter and later put in place a strategic stakeholder strategy to formalize the management of those engagements.
"Funding for devices regulation remains at half the level of 2003 funding in real terms and whilst a number of efficiency measures have been taken, this is against a backdrop of an increase in adverse incident reporting, which has more than doubled since 2007, and an increasing volume and complexity of work due to revolutionary technological advances and new Medical Device Regulations being introduced in 2017/18," MHRA says.
Though there are proposals to introduce a levy for device manufacturer vigilance "that, if successfully implemented, would replace the majority of DH [Department of Health] funding for this area," MHRA says. "However this requires primary legislation and indications from DH are that it is unlikely to secure the Parliamentary time. DH funding has been confirmed for 2017/18."
In addition, MHRA is looking to reinforce networks outside the EU by expanding International Medical Device Regulators Forum (IMDRF) and bilateral relationships, including with the US Food and Drug Administration throughout the year through "(a) development and publication of successive IMDRF event terminology and (b) identification of new IMDRF working groups and shared areas for future collaboration."
On the new EU regulations for medical devices and IVDs, MHRA said the "alignment of UK requirements with these new regulations are expected to be comprehensive, but will depend on the outcome of Brexit negotiations."
MHRA Business Plan 2017-18