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

Welcome to the latest installment of Arnold & Porter’s Virtual and Digital Health Digest. This digest covers key virtual and digital health regulatory and public policy developments during January and early February 2025 from the United States, United Kingdom, and European Union.

In this issue, we discuss some useful international guidance documents from the International Medical Device Regulators Forum (IMDRF). These include Guiding Principles on Good Machine Learning Practices (GMLP) that build on the principles previously set out by the U.S. Food and Drug Administration (FDA), UK Medicines and Healthcare products Regulatory Agency (MHRA), and Health Canada, and guidance on characterization and risks of medical device software. The continued development of international guidance in this area highlights the importance of coordination between regulatory authorities and standardized guidance for these products. There have also been important developments in ongoing litigation relating to digital technologies, although whether these developments provide clear guidance to manufacturers remains to be seen.

Continue Reading Virtual and Digital Health Digest – February 2025

The UK’s General Pharmaceutical Council (GPhC) has published new guidance for registered pharmacies providing pharmacy services at a distance, including on the internet. The GPhC is the pharmacy regulator for Great Britain. Pharmacies and pharmacists, including those operating online, are required to be registered with GPhC and follow the standards it sets.

The prevalence of online pharmacies, “telemedicine” or “telehealth”, has rocketed in recent years and they provide a valuable service. However, cases have been identified where medicines were supplied inappropriately, and people were put at risk. As such, the guidance introduces enhanced safety measures whereby prescribers must take additional steps to ensure the information that a person provides in order to obtain medicines from an online pharmacy is accurate. Notably, medicines categorised as “high-risk” should not be prescribed based on an online questionnaire alone. Pharmacies are required to ensure that their own prescribers meet the requirements and, where they are dispensing product prescribed online by a third-party prescriber, ensure that those prescribers operate in accordance with the guidance.

The guidance covers risk assessments, record keeping and audits, the empowerment of staff and suitable facilities and equipment. However, this blog focuses on the requirements of the digital platform, compliance with laws, the online consultation process, enhanced requirements for “high risk” medicines and working with third-party providers.

Continue Reading Online pharmacies required to strengthen safeguards to prevent unsafe supply of medicines in the UK

PAGB published its updated Professional Code for Medicines (the Code) on 12 February 2025.

PAGB is the UK trade association that represents manufacturers of branded over the counter (OTC) medicines, self-care medical devices and food supplements. PAGB publishes two codes: the Code, which concerns advertising of OTC medicines to persons qualified to prescribe or supply (and people working for them) (PQPS), and a code regarding advertising of OTC medicines to consumers. Together, the two codes are intended to ensure a high standard of conduct and provide a mechanism for industry self-regulation regarding the promotion of OTC medicines in the UK.

The purpose of the updates to the Code was to remove outdated references and streamline content.  The key points that have been updated are set out below.

Continue Reading Proprietary Association of Great Britain (PAGB) updated Professional Code for Medicines

As set out in our previous post, the Innovative Licensing and Access Pathway (ILAP) is an initiative aimed at bringing innovative medicines to the UK market more quickly. On 30 January 2025, the MHRA launched a new version of ILAP in response to feedback from stakeholders.

The first version was launched in January 2021, shortly after the end of the Brexit transition period. It enabled developers to work collaboratively with the NHS, MHRA, and UK Health Technology Assessment (HTA) bodies to bring their product to the UK market in a more streamline and efficient way, benefiting from tailored guidance and support as well as shorter timelines. The scheme saw high levels of applicants, but also faced criticism from stakeholders for a lack of clarity, overly permissive entry criteria and a lack of direct NHS involvement.

Continue Reading The new UK Innovative Licensing and Access Pathway – relaunched, refined, refreshed

Welcome to the latest installment of Arnold & Porter’s Virtual and Digital Health Digest. This digest covers key virtual and digital health regulatory and public policy developments during December 2024 and early January 2025 from the United Kingdom, and European Union.

In this issue, we feature the emerging trends in digital health in 2024 that have been highlighted in IQVIA’s recent report. The IQIVA report is a yearly summary of digital health trends and gives a good snapshot of the market. The latest report notes that Germany continues to lead in its approval and reimbursement of digital therapeutics, followed by the United States and UK.

Continue Reading Virtual and Digital Health Digest – January 2025

On January 14, 2025, the State Administration for Market Regulation (SAMR, 国家市场监督管理总局) published the Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks (the Guidelines, 医药企业防范商业贿赂风险合规指引). The Guidelines are the final version of the Draft Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks (the Draft or the Draft Guidelines) which were published for public comment on October 11, 2024, and discussed in our earlier post. The finalized Guidelines took effect upon publication.

The Guidelines compile the mainstream interpretation of China’s anti-corruption regulatory framework, similar to the Foreign Corrupt Practices Act Resource Guide published by the U.S. Department of Justice and the U.S. Securities and Exchange Commission. The Guidelines are generally consistent with the draft published in October and with best practices in other jurisdictions.

This Advisory highlights key changes from the Draft Guidelines to the final version, particularly with respect to the payment of service fees to healthcare professionals, sponsorships, and the placement of capital equipment.

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 January 1, 2025, new UK-wide arrangements for the supply of medicines came into effect on account of the “Windsor Framework.” The overarching aim is to secure the long-term stability of the supply of medicines to Northern Ireland (NI), ensuring that medicines will be available at the same time, and on the same basis, across the whole of the UK.

To do this, the Windsor Framework changes the regulation of medicines that were formerly within the scope of the EU centralized procedure. Beginning January 1, 2025, medicines for supply in the UK are now authorized UK-wide by the Medicines and Healthcare products Regulatory Agency (MHRA) only and therefore, companies will no longer need to apply for, or maintain, separate licenses for Great Britain (GB) and NI to market novel medicines. Other key changes include removing the requirements of the EU Falsified Medicines Directive (FMD) and a requirement that all medicines placed on the UK market be labeled “UK Only.”

While the changes seek to simplify the post-Brexit regime in the UK, in practice, companies may be faced with meeting two sets of requirements depending on the type of product. We set out an overview of the key requirements in our recent Advisory, although the changes impact a range of regulatory obligations, and we anticipate further complications in the future when the EU Pharma Package is introduced in the EU.

We would be happy to speak further about the detail if you have questions.

Welcome to the last 2024 installment of Arnold & Porter’s Virtual and Digital Health Digest! This digest covers key virtual and digital health regulatory and public policy developments during November and early December 2024 from the United Kingdom and European Union.

Of note, health authorities in the EU continue to develop methods to assess and recommend health apps. The latest is in Denmark, where new guidance has been published on how health apps will be assessed by the Board for Health Apps. The assessment criteria includes evidence of clinical effectiveness, usability, price, and value to society. This guidance is another important step to ensure greater access to health apps across the EU.

It has been a busy year in digital health and the impact to care delivery is only just beginning. We hope you will continue to follow the digest in 2025 as we track what we expect to be an even busier year.   

Wishing you the best for the new year! 
The Arnold & Porter Team 

Continue Reading Virtual and Digital Health Digest – December 2024