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Regulation in healthcare

Blurring of lines between medicines and medical devices is confusing authorisation process, MHRA warns

The regulatory process is not equipped to handle the increasing number of applications that do not clearly fit into categories of ‘medicine’ or ‘medical device’, a spokesperson for the MHRA has warned. 

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An increasing number of medical devices include a medicinal element

Gaps in the medicine authorisation regulatory system are emerging as the line between medicines and medical devices becomes increasingly blurred, the UK’s drugs safety watchdog has warned.

A “significant number” of marketing authorisations made today include a device, while many applications for devices will now have a medicinal component, according to Elizabeth Baker, group manager of the licensing division of the Medicines and Healthcare products Regulatory Agency (MHRA).

“In the past you knew what a medicine was and what a device was. Now there are drug and device kits and the regulatory pathway is challenging,” she said.

Baker said it was essential to decide whether a product was a device or a medicine because there is no combination product classification — or a separate legal basis for regulating them. As a result, she warned that “regulatory gaps are emerging”.

The revised EU medical devices regulation — introduced in May 2017 — does offer stricter controls and regulation around drug/devices combination products, she admitted.

A special medical device co-ordination group is being set up by the European Commission to consult on borderline cases, Baker said, adding that a new EU-wide database of medical devices that introduces unique device identification and ‘patient implant’ cards carrying details of the product will bring improved transparency and better monitoring.

Baker’s warnings come in the report of a one-day onference organised by the MHRA and the UK BioIndustry Association, which considered the UK regulatory environment now and post Brexit; the accelerated access pathway for breakthrough therapies and technologies; drug device combinations; and the importance of real-world evidence in regulatory decision making.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2018.20205514

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