Brexit

EU medical device consultant Trevor Lewis takes note of the recent, if belated, progress towards the building of the post-MDR playing field for medical device companies in Europe, but calls political decision-makers and economic operators to account: getting it right is nothing short of a matter of life and death, he tells In Vivo.

Brexit has been cited as a cause of the UK’s 2020 decline in clinical trials, but research suggests that other global trends including the pandemic also had a large impact. Meanwhile, the MHRA’s efforts to incentivize sponsors could boost trial figures “substantially,” an expert says.

The UK’s drug regulator, the MHRA, has taken a hit in terms of capacity and funding post-Brexit, and could benefit from government backing to rebuild its regulatory capacity, a leading venture capitalist has said.

The UK is not alone in experiencing drug shortages, as data from across Europe show, but its departure from the EU makes it more difficult to respond to supply chain pressures, according to new research.

Guidance from the Medicines and Healthcare products Regulatory Agency says that the packaging of parallel imported medicines must make clear that they are for the UK market only.

The BioIndustry Association has welcomed a decision to delay the deadline for compliance with new regulations on the classification of imported materials used in drug production, but says the border rules are still not proportionate for life science products.

With the UK market experiencing approval delays, shortages, and regulatory complexity, the government’s “policy vacuum” and complacent approach to off-patent medicines risk undermining the sector, says BGMA chair Diane DiGangi Trench. In an exclusive interview with Generics Bulletin, she urges a shift from a “transactional” to a “strategic” relationship with industry to fully unlock the benefits of generics and biosimilars.

A recent ASA ruling against UK firm Supreme CBD highlights the need to be transparent about influencer marketing, as well as to avoid making any medicinal claims for food supplements. 

While Great Britain is on the cusp of a major program of laying the foundations of its agile, post-EU medtech regulatory system, uncertainty persists over the future role and remit of local CABs.

Giving the UK regulator the power to approve new drugs for the whole of the UK rather than just Great Britain will simplify matters, but companies will have to consider making some changes to their product packs before the new legislation kicks in.

Companies wanting to use the new accelerated procedure will be paying more than £68,000 for the privilege, and will have to inform the UK medicines agency of any divergent decisions by reference regulators.

OTC medicines manufacturers operating in Great Britain or Northern Ireland must add a “UK only” label to outer packaging to prevent their OTC products being exported into any part of the European Union. This new packaging artwork can be submitted to the MHRA anytime from now but must be submitted prior to 31 December 2024, advises Jenson R+.     

 Under its new International Recognition Procedure, approval by one of the MHRA's seven “reference regulators” – including the US FDA – as an OTC medicine does not necessarily mean the same status will be granted in post-Brexit UK, warns regulatory consultancy JensonR+.

New guidance from the MHRA covers the issuing of UK-wide approvals for all medicines from 2025, the conversion of Great Britain product licences to UK licences, and issues relating to the approval of generics and the use of reference and comparator products.

An assessment of the European Medicines Agency’s performance in tackling the COVID-19 pandemic shows that the agency was “well prepared” with a crisis management plan but that it faced a range of challenges such as the fallout from Brexit, a heavy workload and how to maintain the public’s trust in medicines regulation.

The European Medicines Agency said Noël Wathion, who retired two years ago, will be remembered for steering the agency through challenges such as Brexit and COVID-19, in addition to being a champion of transparency and public engagement.

One of the many consequences of Brexit is that medicines for marketing across the UK will have to carry the words “UK Only,” which will involve companies having to notify the regulator of changes to their product artwork.

Digitalization is a hot topic in consumer health, and “digital health” covers a broad spectrum of applications, from wellness apps to virtual reality therapeutics. In this episode of Over The Counter, HBW Insight speaks to Jamie Hatzel, regulatory associate at law firm Bristows, to get some clarity on “software as a medical device” – a subset of medical device regulatory frameworks within which many digital health applications are classified. In the first part of a two-part podcast, Hatzel outlines the UK and EU regulatory approaches to SaMDs, before we discuss specific examples such as symptom trackers, wellness apps and digital therapeutics.

Countries from all over the world were plying their wares as desirable biotech clusters at the recent BIO meeting in Boston and Northern Ireland made a strong case for its potential as a prime location for life sciences starts-ups.

Prompted by Brexit, the UK is weighing up an overhaul of how novel foods are regulated. The Food Standards Agency has drawn up options for new regulatory models, some of which it says represent a "radical" departure from the current framework.