UK

On 31 July 2025, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) issued a statement of policy intent relating to a service to provide early access to the Great Britain market for innovative medical devices (“Early Access Service”).  Although this statement is non-binding, it indicates further efforts by the MHRA to reduce unwarranted barriers to market entry, through faster, risk-proportionate, and predictable routes to regulatory approval – in line with Action 25 of the Life Sciences Sector Plan (published on 16 July 2025).Continue Reading MHRA Issues Statement of Policy Intent Regarding Early Access to Innovative Medical Devices

On 22 July 2025, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) published the outcome of its most recent medical device-related consultation.  The MHRA also announced its intention to consult further on the indefinite recognition of CE-marked medical devices in Great Britain, with this consultation expected to take place later in 2025.Continue Reading MHRA Announces Consultation Response on Reforms to GB Pre-Market Medical Device Regulation

On 29 January 2025, NHS England (“NHSE”) published an updated Commercial Framework for New Medicines (the “Commercial Framework”). The Commercial Framework, first published in 2021, sets out NHSE’s approach to commercial activity in relation to new branded medicines and is a key document in the UK’s pricing and reimbursement landscape.

The Commercial Framework clarifies and consolidates a number of points, as well as introducing new changes. Continue Reading The Updated NHS Commercial Framework for New Medicines

On 30 January 2025, the UK Government announced the re-launch of the Innovative Licensing and Access Pathway (“ILAP”) for medicines.

The ILAP is an “end-to-end” access pathway offering a unique opportunity for a medicine’s developer to engage with: (i) the UK’s medicines regulator – the Medicines and Healthcare products Regulatory Agency (“MHRA”); (ii) England’s HTA body – the National Institute for Health and Care Excellence (“NICE”); and (iii) and the National Health Service (“NHS”) (together the “ILAP Partners”).  By providing medicines developers with joined-up, co-ordinated and tailored guidance from the ILAP Partners, from the early stages of clinical development, the ILAP scheme hopes to accelerate the time to market for innovative and transformative medicines and drug-device combinations.Continue Reading Re-Launch of UK’s Innovative Licensing and Access Pathway (“ILAP”)

The UK’s Medicines and Healthcare products Regulatory Agency (“MHRA”) is seeking industry feedback on its new draft guideline on individual messenger ribonucleic acid (“mRNA”) cancer immunotherapies (the “Draft Guidance”).  Building on the success of mRNA vaccine technology in response to the Covid-19 pandemic, the technology is now being adapted to target diseases such as cancer.  The MHRA aims to provide a streamlined robust regulatory framework for the approval of such personalised mRNA-based cancer vaccines without compromising safety.

The Draft Guidance covers the regulatory classification of these novel cancer treatments, product design and manufacture, non-clinical and clinical development, pharmacovigilance and the distribution of information to the wider public.  Notably, the MHRA explicitly acknowledges that the regulatory and scientific principles discussed in the Draft Guidance could broadly apply to other disease indications or technologies that could benefit from personalisation or individualisation.  Therefore, industry should be aware that the scope of the Draft Guidance may be extended in the future beyond mRNA cancer immunotherapies that use lipid nanoparticle delivery systems to other delivery systems and disease areas.  Manufacturers, developers, patient organisations and other stakeholders have until 31 March 2025 to comment on the Draft Guidance.

We explore some of the interesting regulatory considerations arising from the Draft Guidance below.Continue Reading MHRA Consultation on Individualised mRNA Cancer Immunotherapies – Unique opportunity for a streamlined risk based regulatory framework?

On 23 January 2025, we hosted the 2025 edition of the Covington European Life Sciences Symposium. The Symposium brought together colleagues from London, Brussels, Frankfurt and Dublin with our industry connections to explore the evolving challenges and opportunities facing the European life sciences sector.Continue Reading The Covington European Life Sciences Symposium 2025

In recent weeks, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published further guidance relating to the implementation of the Windsor Framework.  From 1 January 2025, changes due to the Windsor Framework for the licensing, labelling and wholesale dealing of human medicinal products in the UK will become effective.  The new measures require, amongst other things: (i) all human medicinal products intended for the UK market to be authorized by the MHRA; (ii) a single UK-wide pack that bears a “UK only” label; and (iii) disapplication of the EU Falsified Medicines Directive 2011/62/EU (“EU FMD”) requirements to UK-wide packs. 

Following the MHRA’s initial publication of guidance focusing on the changes to labelling and packaging (please see our blog post here), the Agency has now issued guidance relating to wholesalers and manufacturers (“Wholesaler and Manufacturer Guidance), licensing (“Licensing Guidance”) and advertising (“Advertising Guidance”).

We explore some of the key requirements and recommendations for supply chains and promotional material arising from this new guidance below.Continue Reading Are you Windsor Framework ready? A focus on pharmaceutical supply chains and promotional material

Last month we provided an update on the UK Government’s draft post-market surveillance statutory instrument (“PMS SI”) and the UK Medicines and Healthcare products Regulatory Agency’s (“MHRA’s”) intention to run a further public consultation on proposed changes to pre-market medical device regulation under an upcoming statutory instrument (“Pre-Market SI”).

On 14 November 2024, the MHRA launched a consultation on proposed pre-market regulatory changes for medical devices and in vitro diagnostic (“IVD”) devices (the “Consultation”).  The MHRA intends to incorporate the feedback from the Consultation in drafting the Pre-Market SI.Continue Reading MHRA Consults on New UK Pre-Market Medical Device Measures

On 21 October 2024, the UK Government laid the draft Post-market Surveillance statutory instrument (“PMS SI”) before Parliament (see the UK Medicines and Healthcare products Regulatory Agency’s (“MHRA’s”) press release here).  Once implemented, the PMS SI will further amend the UK’s Medical Devices Regulations 2002 (“UK MDRs”) by introducing new vigilance requirements for medical devices already on the Great Britain (“GB”) market.  The proposed updates to the UK MDRs seek to bring it into greater alignment with the EU’s Medical Devices Regulation 2017/745 (“EU MDR”) and In Vitro Diagnostic Medical Devices Regulation 2017/746 (“EU IVDR”), whilst also taking advantage of certain opportunities resulting from the UK’s withdrawal from the EU to build on and diverge from this legislation.Continue Reading UK’s Medical Device Post-market Surveillance Statutory Instrument Laid Before Parliament – What are the Key Changes for Medical Device Regulation?

Those of us who advise on medicines advertising issues have been waiting for much of 2024 for the Association of the British Pharmaceutical Industry (“ABPI”) together with its self-regulatory body for pharmaceutical advertising, the Prescription Medicines Code of Practice Authority (“PMCPA”), to publish the new Code of Practice for the Pharmaceutical Industry (“ABPI Code”).  On 23 September 2024, the suspense finally lifted, with the publication of the ABPI Code 2024 (available here).  The 2024 ABPI Code replaces the previous version from 2021. 

The new ABPI Code incorporates an updated PMCPA Constitution and Procedure, which sets out the procedure for adjudicating upon advertising complaints.

The ABPI initially proposed, and consulted upon, updates to the ABPI Code from December 2023 to February 2024 (please see our previous blog post discussing these proposals here).  The 2024 ABPI Code includes most of the changes that were proposed and consulted upon, usually with only minor changes to wording.  The PMCPA has issued summaries of the changes to the Code and Constitution, which can be found here and here.

The main headline is that the new ABPI Code is very similar to its predecessor.  The consultation received over 3,000 comments, with many commentators calling for more extensive changes than those proposed.  The ABPI appears to have resisted these calls, preferring evolution over revolution.

The changes take effect on 1 October 2024.  However, a transitional period will operate from 1 October 2024 to 31 December 2024, during which time no material or activity will be regarded as breaching the ABPI Code if it fails to comply with the new requirements of the 2024 version.  The 2024 ABPI Code will come into full force on 1 January 2025.  Notably, though, the PMCPA will begin operating in accordance with the new Constitution and Procedure from 1 October 2024, including the legalistic elements and abridged complaints procedure discussed below.

Of the (relatively few) changes, what should legal and compliance teams take note of?

The new PMCPA Constitution and Procedure makes changes to the process for investigating and adjudicating upon advertising complaints.  These changes aim to enhance the flexibility and efficiency of the complaints process.  They include: (i) powers for the PMCPA to issue case management directions; and (ii) a new abridged complaints procedure that could apply in certain cases.  The changes will likely result in a more legalistic feel to PMCPA proceedings.  If the PMCPA notifies a company of a complaint, it may be beneficial to involve legal teams early in the process.

By contrast, changes to a company’s compliance obligations under the new ABPI Code are relatively modest.  The updates are generally clarificatory in nature.  Some changes essentially consolidate and codify into the Code principles that already exist in guidance and previous PMCPA cases.  An example of this is how companies fulfill their obligation to maintain high standards.  There is now more detail on this point in the Code, pulling together concepts from various cases. 

There are also new rules permitting the use of QR codes to provide access to prescribing information in certain cases.Continue Reading New ABPI Code and PMCPA Constitution and Procedure Published