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

In the UK General Election on 4 July, the Labour Party won 412 of the 650 seats, giving it a comfortable majority. Its leader, Sir Keir Starmer, became Prime Minister, meaning a change of government from Conversative to Labour for the first time in 14 years.

In its campaign, Labour focused on the need to deliver economic growth and innovation in critical industry sectors. It also placed considerable emphasis on addressing the problems facing the National Health Service (NHS), such as long waiting lists for treatment, old equipment and an increasingly ageing population.

The government’s economic priorities were further set out in the first major speech delivered by the new Chancellor of the Exchequer Rachel Reeves on 8 July, in which she said that growth “is now our national mission”. The Health Secretary Wes Streeting also noted his intention of making the Department of Health and Social Care a department for economic growth. While each of these are statements of intent and not binding on the new government, they provide valuable insight into what industry can expect over the next 5 years. We set out below some of the most relevant initiatives that could impact the industry.Continue Reading What does the new UK government mean for life sciences?

In a previous blog post, we discussed the UK government’s proposed changes to the regulatory framework governing clinical trials. Marking the start of this legislative change is a new notification scheme for the lowest-risk clinical trials (the scheme), published on 12 October 2023. The scheme is based on the proposal set out in the Medicines and Healthcare Regulatory Agency’s (MHRA) consultation earlier this year, which was supported by 74% of respondents.

The scheme allows for the processing of eligible clinical trials by the MHRA in less than 14 days, instead of the statutory 30 days. The scheme currently only applies to clinical trial authorisation (CTA) applications for Phase 4 and certain Phase 3 clinical trials deemed as low risk, and provided they meet the MHRA’s eligibility criteria, set out below. Initial “first in human” Phase 1 or Phase 2 trials and clinical trial amendment applications will not be eligible.

The scheme aims to reduce the time taken to get lowest-risk clinical trials up and running, to give UK patients quicker access to potentially life-saving medicines, without undermining patient safety. The MHRA encourages clinical trial sponsors to use the scheme for all eligible trials and estimates that this will include 20% of UK initial clinical trial applications.Continue Reading UK clinical trials – new notification scheme for lowest-risk clinical trials

At the beginning of July, the MHRA published its 2023 – 2026 Corporate Plan, which highlights, amongst many other topics, the importance of introducing new legislation and guidance on clinical trials in the UK to help provide the “stable and predictable regulatory environment that companies require”. The intention is that by 31 March 2026, the MHRA will implement a revised regulatory framework for clinical trials.

Work on a new clinical trial framework is already underway. On 21 March 2023, the MHRA published its response to the UK consultation (which ran from 17 January to 14 March 2022) on legislative proposals for changes to the law governing clinical trials, namely the Medicines for Human Use (Clinical Trials) Regulations 2004.

Responses demonstrated strong support to update and improve the legislation governing clinical trials, with most respondents agreeing that patient safety should remain the focus of the legislation, but with a more flexible and risk proportionate approach to decision-making. In line with responses to other recent consultations, the MHRA is looking to align with international standards rather than be limited by alignment with the EU. It is hoped that the implementation of the proposals will make it easier and more efficient to run trials in the UK, enabling greater patient access to new, safe and life-changing treatments, while retaining the UK as an attractive place for trials.

In terms of next steps, the drafting of the statutory instrument to update the clinical trials legislation is expected to be laid before parliament in the Autumn of 2023. Comprehensive guidance will also accompany the legislation.Continue Reading Legislative change is afoot for clinical trials conducted in the UK

In May 2021, the U.S. Food and Drug Administration (FDA) published a draft guidance (Draft Guidance) addressing the requirement for all investigators involved in clinical trials conducted under a U.S. Investigational New Drug (IND) application to sign Form FDA 1572. This includes investigators in clinical trial sites outside the U.S.

By signing Form FDA 1572 (Form 1572), the investigator of a drug or biologic trial warrants that they and any listed staff have the experience and background needed to conduct the trial and agrees to comply with the protocol and all applicable U.S. regulatory provisions governing the conduct of clinical trials.  From an FDA standpoint, it provides a clear basis of responsibility (and potential liability) under the applicable clinical trial regulations (21 CFR 312) for those who sign the form.  It also raises questions about the extent of FDA’s extraterritorial reach over non-U.S. investigators who conduct IND studies outside of the United States.Continue Reading FDA Guidance on Clinical Investigators Signing Form FDA 1572 and Practical Challenges Outside the US

The UK MHRA has issued draft guidance on randomised controlled trials generating real-world evidence (RWE) that is used to support regulatory decisions. It is intended to be the first in a series of guidance documents addressing RWE. The guidance is part of the MHRA’s push to reinforce the view of the MHRA as a pro-innovative regulatory authority, and that the UK is a leading country in which to conduct clinical research, post-Brexit.
Continue Reading UK MHRA consultation on real-world evidence

On 7 September 2020, the European Data Protection Board (EDPB) initiated a public consultation on draft Guidelines 07/2020 on the concepts of controller and processor in the GDPR. Any interested party could provide comments by 19 October 2020 using the dedicated form.

The draft Guidelines contain elements that are of interest for companies active in the life science sector as they may have an impact on comapnies’ day-to-day research and commercial activities in the EU and their compliance with Regulation (EU) 2016/679 (GDPR).
Continue Reading Draft EU guidelines on the concepts of controller and processor—key elements for life sciences companies

Earlier this month, we commented on the European Commission proposal for a Regulation accelerating existing procedures for clinical trials where medicinal products containing or consisting of Genetically Modified Organisms (GMOs) are tested for the development of vaccines and therapies to treat COVID-19. The European Commission had proposed that, during the pandemic and by derogation to the GMO regulatory framework, the requirement of a prior environmental risk assessment or consent by the national competent authorities should not apply.
Continue Reading Update: Regulation for COVID-19 clinical trials conducted with medicinal products containing or consisting of GMOs has now been adopted