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After Brexit

Set Alert for Brexit

MHRA Needs ‘Rebuilding’ After Post-Brexit Loss Of Capacity And Industry Investment

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.

BioPharmaceutical Policy

Post-Brexit UK Risks Being ‘Left Out In The Cold’ As EU Coordinates Action On Shortages

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.

Europe United Kingdom

UK Explains New Rules On Parallel Imports From EU

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.

Europe United Kingdom

UK Industry Gets More Time To Adapt To Post-Brexit Import Rules

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.

Europe United Kingdom

Fixing The UK Market: Government Must Move From ‘Transactional’ To ‘Strategic’ Approach

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.

United Kingdom Policy

ASA Files: How Not To Advertise A CBD Food Supplement In The UK

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. 

United Kingdom Wellness

UK Approved Body Capacity Rises But Not For IVDs

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.

United Kingdom Regulation

Companies Told To Prepare For New Rules On UK-Wide Drug Approvals

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.

Europe Approvals

UK’s New International Recognition Procedure A ‘Win-Win’ For Stakeholders

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.

United Kingdom Health

Post-Brexit Windsor Framework: Start Submitting ‘UK Only’ OTC Medicines Packs To MHRA

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+. 

United Kingdom Health

UK MHRA’s International Recognition Procedure Does Not Guarantee OTC Status

 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+.

United Kingdom Health

UK Regulator Attempts To Demystify Upcoming Drug Approval Rules

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.

Europe United Kingdom

EMA ‘Needs More Resources’ If EU Rolling Reviews Are To Be Used More Widely

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.

Europe Brexit

Noël Wathion, Former EMA Deputy Executive Director, Dies Aged 66

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.

Europe EU

UK Explains New Product Labeling Rules From January 2025

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.

Europe United Kingdom

Over The Counter 24 July 2023: What Is ‘Software As A Medical Device’ And How Is It Regulated In Europe? With Bristows’ Jamie Hatzel

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.

Europe Health
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