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The UK government has published its response to the recent consultation on the UK Medical Devices Regulations. As highlighted throughout the process to date, the focus is on improving regulatory scrutiny and oversight of medical devices and IVDs in the UK. Changes are aimed at closer alignment with international best practice and to ensure that Great Britain has risk proportionate regulations. Changes are not intended to introduce the EU Medical Devices Regulations into UK law, although there are of course similarities, which has been welcomed by those responding to the consultation.

There were four key areas under consultation: (1) International reliance, (2) UKCA marking, (3) IVD devices, and (4) Assimilated EU law. We have set out a summary on each of these below.Continue Reading UK Medical Devices Regulations: further changes afoot

The European Medicines Agency (EMA) has published a draft Reflection Paper proposing a streamlined pathway for the approval for certain biosimilar medicinal products (biosimilars) in the EU by reducing the clinical data requirements where justified.

Biosimilars are biological medicinal products that are demonstrated to be highly similar to an already authorised biological medicinal product, known as the reference medicinal product (RMP), with no clinically meaningful differences in terms of quality, safety, or efficacy. Biosimilar marketing authorisation applications are subject to reduced data requirements compared to a full application. However, the applicant must submit a data package from a comparability exercise demonstrating that the purported biosimilar is highly similar to the RMP. Typically, this will require a comparative Clinical Efficacy Study (CES) to confirm the similarity (though this requirement can already be waived in certain circumstances).

In its Reflection Paper, the EMA sets out the prerequisites for more general principles for when requirements for a CES may be waived, and only a limited, targeted clinical data package (based on a comparative pharmacokinetic (PK) trial) will be accepted. Where this approach is adopted, this is likely to reduce the clinical development burdens for biosimilar companies.Continue Reading The European Medicines Agency Proposes Streamlined Pathway for the Approval of Biosimilar Medicinal Products in the EU

On 11 April 2025, the MHRA announced  that the much anticipated changes to the clinical trial rules in the UK, the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024 (the new Regulations), have been signed into law.

In January, we posted a detailed blog on the upcoming changes to the UK law governing clinical trials, noting that this had been described as the “biggest overhaul of the clinical trial regulations in 20 years”, and is intended to cement the UK as a world-class destination for conducting international clinical trials, to “support [a] more streamlined and flexible regulation of clinical trials, removing unnecessary administrative burdens on trial sponsors, whilst protecting the interests of trial participants.”

The new Regulations will come into effect on 10 April 2026, following a 12 month roll out period. The MHRA states in its announcement that it is “committed to implementing a flexible and risk-proportionate regulation of clinical trials, which accelerates patient access to potentially life-saving medicines without compromising safety.”Continue Reading Recent updates on reform of UK clinical trial landscape

On 3 February 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) launched a consultation asking for stakeholders’ views on  draft guideline in relation to the regulation of individualised mRNA cancer immunotherapies (Draft Guideline).

The aim of the proposed guideline is to establish a clear and streamlined regulatory pathway to authorisation so that these highly innovative products can be made available to patients quickly, without compromising any assessment of safety. While the primary focus of the Draft Guideline is individualised messenger Ribonucleic Acid (mRNA) cancer immunotherapies, MHRA suggests that the regulatory and scientific principles considered might be broadly applicable to other disease indications (including rare diseases) or technologies that could benefit from personalisation or individualisation. It also states that the Draft Guideline will be updated when experience of other technologies (peptides, non-integrative DNA and polymer deliver systems) is available.  

In terms of regulatory assessment of individualised mRNA cancer immunotherapies, the Draft Guideline provides clarification of the data which should be included in marketing authorisation (MA) applications and, importantly, confirms that an individualised medicine may, in some circumstances, be granted an MA under the Human Medicines Regulations 2012 (HMRs), even where the product includes an individualised component tailored to the requirements of a specific patient.

There is currently substantial interest in the use of mRNA technology to develop individualised treatments for cancer. The current consultation is therefore of interest to companies focussing on this and other individualised therapies.Continue Reading The UK’s MHRA launches consultation on draft guideline on individualised mRNA cancer immunotherapies

2025 promises to be a year of further advancements in the UK’s life sciences sector and one important area of on-going development is the regulation of clinical trials.

After some delay, the much anticipated Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024 (the new Regulations) were laid before Parliament on 12 December 2024, intended to amend the current UK framework governing clinical trials. This has been described as the “biggest overhaul of the clinical trial regulations in 20 years”, and is intended to cement the UK as a worldclass destination for conducting international clinical trials, to “support [a] more streamlined and flexible regulation of clinical trials, removing unnecessary administrative burdens on trial sponsors, whilst protecting the interests of trial participants.”

Key changes proposed by the new Regulations are discussed below. While certain regulatory requirements will be set out in the legislation, the aim is to move away from a “one-size-fits-all” approach, allowing for a more proactive response to innovation. This is in line with the new streamlined notification scheme for lowest risk clinical trials, which the MHRA introduced in October 2023, as discussed in our previous blog post. As such, the new Regulations have been described as “as future-proof as possible and […] responsive to different types of trials and innovative ways of carrying out trials.”

The new Regulation will be debated in Parliament in early 2025 and, after a 12 month implementation period, the aim is for the new Regulations to come into force in early 2026. In addition, guidance, which is already under development, will be used for specific details, rather than the new Regulations being too granular and prescriptive. The aim is for the guidance to become ‘live’ in January 2026, to coincide with the new Regulations.  Continue Reading New Year Update: incoming changes to UK regulation of clinical trials

On 21 October 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) announced that the UK will be the first country in the world to introduce a tailored framework for the manufacture of innovative medicines at or close to the location where a patient receives care.

A new statutory instrument was laid before the UK parliament to amend the Human Medicines Regulations 2012 and the Medicines for Human Use (Clinical Trials) Regulations 2004, to provide a new regulatory framework to support the manufacture and supply of these innovative products. This includes:

  1. products with a very short shelf life and highly personalised medicines that mean they have to be manufactured close to the place where they are administered; known as Point of Care, or POC, products. This often applies to advanced therapy medicinal products (ATMPs), but could also be technologies such as 3D printing.
  2. products that are manufactured in a self-contained modular unit, to enable deployment from that site to other locations; known as Module Manufacture, or MM, products.

This new framework follows a consultation in 2021, discussed in a previous blog post. The consultation received overwhelming support, and 91% of responders agreed with the need for a new regulatory framework. At present, there is no specific framework that covers decentralised manufacturing of medicines in the UK, but as products become more innovative, and more personalised to the patient, the need for change has increased. At present, any on-site manufacturing has to rely on the hospital having obtained the necessary licences and having put in place the required quality, safety and traceability standards under the general framework. This leads to practical – and contractual – difficulties between the company and hospital sites.

The new framework seeks to provide the necessary regulatory oversight to ensure that POC and MM products have appropriate quality, safety, and efficacy attributes, whilst allowing increasing numbers of patients to benefit from these innovative products. According to the MHRA, the proposed regulation ensures that POC and MM products can be more easily made in or near a hospital setting and can get to the patients who need them safely and more quickly.Continue Reading UK to implement novel framework for point of care manufacture of medicinal products

On 24 April 2024, the European Parliament formally adopted the Regulation on Standards of quality and safety for Substances of Human Origin (SoHo) intended for human application (the SoHO Regulation). On the same date, the European Commission published a Questions & Answers (Q&A) document on the SoHO Regulation. Then on 27 May 2024, the EU Council adopted the new rules. For the final step in the legislative process, the new Regulation is due to be published in the Official Journal shortly.

The SoHO Regulation aims to introduce new and innovative measures to help ensure that high standards of safety and quality for SoHO are maintained across the EU and that SoHO activities are appropriately regulated.  A key goal is to facilitate cross-border exchanges and access to SoHOs across the EU, while ensuring high levels of health for donors, recipients and offspring from medically assisted reproduction. A more harmonised approach to the regulation of SoHO across the EU is envisaged, which will be welcomed by industry. However, Member States may still diverge and include more stringent measures under their national laws. The extent to which one Member State’s authorisation of a SoHO Entity, SoHO establishment or SoHO preparation is really “EU wide” therefore remains to be seen. Furthermore, the success of the SoHO Regulation is reliant upon cooperation and coordination between Member States, including the use of the SoHO Platform and seeking opinions from the SoHO Coordination Board on borderline issues. This will require continuous contact between Member States and a good understanding of the ever-developing and innovative uses of SoHOs. Guidance accompanying the new rules, as well as what measures need to be put in place from the outset, will need to be informative, clear and proportionate for the SoHO Regulation to make the differences it is intended to achieve.Continue Reading European Parliament adopts Regulation on substances of human origin (SoHO)

On 11 March, the European Commission adopted the proposal for a Delegated Regulation to amend Regulation (EC) No 1234/2008 as regards the examination of variations to the terms of marketing authorisations for medicinal products for human use: Commission Delegated Regulation (EU) 2024/1701 of 11 March 2024. The amendments will apply from 1 January 2025.

Scientific and technological advancements have led to a rise in the number of requests for variations to marketing authorisations (MA) and have brought the need to revise the variations procedure to make it more efficient and adaptable to change, in particular in relation to biological medicinal products, vaccines and medical devices.

The proposal aims to make the variations procedure simpler, clearer and more flexible to be able to respond to scientific and technological progress, and to reduce administrative burden.Continue Reading European Commission proposal to amend the Variation Regulation for Medicines

A version of this article was first published in Life Sciences IP Review

There is currently no specific legislation in the UK that governs AI, or its use in healthcare. Instead, a number of general-purpose laws apply that have to be adapted to specific AI technologies. As a step towards a more coherent approach, the government recently published its response to its consultation on regulating AI in the UK.  This maintains the government’s “pro-innovation” framework of principles, to be set out in guidance rather than legislation, which will then be implemented by regulatory authorities in their respective sectors, such as by the MHRA for medicines.  The MHRA has already started this process and signalled itself as an early-adopter of the UK government’s approach. The hope is that this will lead to investment in the UK by life science companies as the UK is seen as a first-launch country for innovative technologies.Continue Reading The UK’s pro-innovation approach to AI: What does this mean for life science companies?

On 23 January 2024, the European Commission announced proposals to amend the Medical Device Regulations (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Device Regulations (EU) 2017/746 (IVDR), as applicable, to:

  • extend the transition provisions for certain in vitro diagnostic medical devices (IVDs) under the IVDR
  • allow for a gradual roll-out of Eudamed so that certain modules will be mandatory from late 2025
  • include a notification obligation in case of interruption of supply

The proposal will now need to be adopted by the European Parliament and Council before it enters into force. However, as the proposal follows a similar structure to the recent amendments to the MDR, we do not anticipate significant changes during the legislative process.Continue Reading Commission proposes extension to IVDR transition periods and accelerated launch of Eudamed