European Regulatory Roundup: MHRA Offers Draft Guidance on Device and Combo Products (16 June 2016)

Posted 16 June 2016 | By Nick Paul Taylor 

European Regulatory Roundup: MHRA Offers Draft Guidance on Device and Combo Products (16 June 2016)

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

UK Parliamentary Committee Calls for Urgent Creation of Post-Brexit Contingency Plans

A United Kingdom parliamentary committee has called for the government to immediately establish contingency plans to protect scientific organizations from the fallout of the public voting to leave the European Union. The committee made the recommendation after its analysis of the situation led it to conclude leaving the EU would create near-term challenges for drugmakers and other organizations.

Members of the Science and Technology Committee have spent several months gathering written evidence from life science organizations that are active in the UK and holding face-to-face discussions with their representatives. This has led to the creation of a 38-page report, in which the cross-party committee of politicians breaks down the pros and cons of being involved in the EU from the point of view of life science companies and other scientific research groups. While the report is not supposed to express an opinion on the merits of Brexit, its authors appear concerned about the consequences.

Citing the revocation of access to EU funding and collaboration that followed a Swiss vote on the free movement of people, the authors advise the government to prepare for fallout from Brexit. “Given the cautionary example of the Swiss freedom of movement referendum, we urge the Government to conduct a risk analysis of the science and innovation funding and collaboration scenarios in the event of Brexit and put in place immediate contingency plans to protect our science and innovation sector from any adverse consequences and to consolidate any benefits,” the committee wrote.

The example of Switzerland is pertinent given the argument espoused by some in favor of Brexit that the arm’s length relationship it and countries such as Norway have with the EU are examples of how Britain can enjoy the benefits of close ties with the region without the costs. An alternative reading of the situation is that countries such as Switzerland remain beholden to EU regulation but lack a way to influence it. The report provides evidence to support this latter argument, as well as comments that suggest Britain is having some success in influencing the content of EU regulations.

Committee Chair Nicola Blackwood, a Conservative politician in favor of staying in the EU, said, “If we left, our life sciences sector would still have to follow EU regulations to sell in the single market. But Britain wouldn't get a say in setting those rules, putting us at a competitive disadvantage.” As it stands, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) “has been able to exploit its reputation, leadership and expertise to positively influence the EU medicines regulatory regime,” the report found.

The committee has some concerns with the function of the EU in life sciences, though. Major shortcomings mentioned in the report include the “inflexible and inconsistently applied” Clinical Trials Directive, the length of time it has taken to improve this and other regulations and the willful misuse of the precautionary principle in areas such as genetically modified organisms. If Britain remains in the EU, the committee wants to see the government take action to address these issues. At the time of writing, polls suggest the campaign to leave the EU is winning. The vote will happen on 23 June.

Committee Statement, Full Report

MHRA Drafts Guidance on Usability of Medical Devices, Combination Products

MHRA has published draft guidance on the usability of medical devices and combination products. The text covers the design processes manufacturers can follow to reduce the likelihood that their products will harm users, a risk MHRA wants companies to pay more attention to as the complexity of their devices increases.

Members of the MHRA Human Factors Task and Finish group put together the guidance following a meeting last year to discuss the topic with the industry. The result of the meeting and subsequent discussions is a 30-page document that walks readers through the process of designing a device that is adapted to the needs of users, from simulations to test a product during development, through to the collection of feedback post-approval to inform continuous improvement. The text also addresses the specific needs of drug-device combination products.

MHRA sees the guidance leading to the development of well-designed, ergonomic devices, products that it thinks can deliver a range of benefits. “In addition to safety considerations, products designed with human factors and ergonomics principles are more pleasing to use, therefore will be likely to lead to better adherence to correct use, at the required frequency,” the regulator wrote in its draft guidance. MHRA’s ideal device is “easy to use, with a helpful, intuitive user interface,” characteristics it thinks increase the likelihood of the product being used correctly.

The regulator’s interest in device design has increased in response to changes in the industry. With medical devices playing important roles in the treatment and monitoring of disease, MHRA sees the development of unintuitive products as a potential risk to human health. This risk is particularly high in environments in which users of the device are very busy, a description that applies to many of today’s healthcare settings. “With ever greater distractions and requirement for specialized training, the potential for human error also increases,” MHRA wrote in its guidance.

MHRA is accepting comments on the text until 5 August.

MHRA Statement, Draft Guidance

EMA Switches to Single, Central Platform for Periodic Safety Update Reports

The European Medicines Agency (EMA) is now mandating that all periodic safety reports (PSUR) are sent to its centralized repository. EMA made the switch to the PSUR repository on 13 June, and in doing so stopped marketing authorization holders (MAHs) from being able to submit safety reports to national competent authorities (NCAs).

Officials at EMA are presenting the transition to PSUR repository as an “important simplification” for MAHs, specifically because it enables them to send all their safety reports to a single location. For EMA, NCAs and other organizations that rely on PSURs to make safety assessments, centralizing the reports means they will always have access to an up-to-date repository of documents. Given the role PSURs play in EMA assessments of the risks and benefits of medicines, access to such a repository is an important enabler of some of its key responsibilities.

The regulator gained access to such a resource when it set up the repository in January 2015, but until this week MAHs could continue to send PSURs to NCAs, as they did prior to the creation of the centralized platform. EMA has spent the past 18 months — in particular the 12 months since its management board signed off on the use of the repository — working to prepare MAHs and NCAs for the transition to the new system. This process has entailed the creation of guidance and training programs, as well as modifications to the platform to align its features with feedback from users.

That process continued this week with the release of a question and answer document covering the switchover to the centralized repository. The Q&A addresses the process for submitting PSURs to the repository, which uses the eSubmission Gateway, and clarifies that MAHs can only meet their legal reporting obligations by sending safety reports to the centralized platform.  

Press Release, EMA Q&A


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