UK Windsor Framework Enters Into Force

Recent UK regulatory developments of potential interest to international life sciences companies include: reforms aimed at speeding up medicines approvals and market access, global firsts with respect to certain orphan drug and cancer diagnostic approvals, and updates on unified packaging and labeling across the UK. Article authored by Dr. Chris Boyle and Dr. Kwabena Tenkorang.

Several recent developments in the regulatory environment for life sciences companies in the United Kingdom (UK) may be of commercial relevance to international pharmaceutical and medical devices companies seeking to market products in the country, particularly those with headquarters in the U.S. or the EU. The UK is actively seeking to restore its position as a world leader in life sciences, capitalizing on UK-specific opportunities, such as its unique “treasure trove” of health data and its centers of scientific excellence. The UK’s goal is to create a national environment that facilitates research, development, and early commercialization of cutting-edge medicines and medical device technologies.

For example, in March 2025, the UK Medicines and Healthcare products Regulatory Agency (MHRA) announced the launch of seven new Centers of Excellence in Regulatory Science and Innovation (CERSIs), that are intended to help drive advancements in healthcare. CERSIs can be led by academic institutions, independent innovators, or regulatory leaders forming collaborative partnerships. Projects will receive funding of up to £1 million each, to lead the way for safer, faster pathways for innovative medicines and devices; £6.2 million has been invested across seven funded projects in human healthcare so far. These projects focus on advanced therapies, precision medicines, digital healthcare, drug discovery, and diagnostics. A further £4.7 million has been invested for 11 new networks to develop regulatory science (non-human health).

In April 2025, it was also announced that the government and Wellcome Trust will invest £600 million into a new Health Data Research Service to simplify secure access to health data, with a streamlined single access point for patient data sets. The government has also pledged to cut the time taken to set up a clinical trial from 250 to 150 days.

These are examples of the legislative and non-legislative initiatives designed to boost the UK life sciences ecosystem. International life sciences companies would also be well advised to take particular note of the following recent developments in the UK:

Windsor Framework comes into force with attendant requirements for packaging and labeling.

The Northern Ireland Protocol was part of the UK-EU-UK Withdrawal Agreement following Brexit. An amended protocol, which is referred to as the “Windsor Framework,” came into force on January 1, 2025. As a result of this change, manufacturers should carefully check their labeling, advertising, and operations in consultation with legal counsel. This is to ensure that products are now fit for the UK market rather than for that of Great Britain (the UK, excluding Northern Ireland), noting the following conditions which have been applicable since January 1, 2025:

• “GB Only” has become “UK Only,” with Northern Ireland (NI) being included. Parallel Distribution Notices (PDNs), which cross-border distributors of EU-centrally authorized products must obtain, have ceased to be valid in NI. PDNs have been replaced by Parallel Import Licences (PLPIs), although license numbers have not changed.
• Labels, leaflets, and packaging materials must now be updated and/or amended to include the prefix “PL,” referring to “Product Licence number.” The “UK Only” statement must be displayed on all UK-licensed medicines. Of particular note, the “UK Only” statement can only be applied to medicines by a sticker (over labelling) until 30 June 2025. After this date, “UK Only” must be printed directly onto packaging. Different rules apply to parallel import products, which can continue to use over labelling.

For more detail on these developments, please see our previous blog post here. The MHRA has published a “Windsor Framework explainer.” It has also published specific guidance on how the advertising and promotion of medicines, registration of medical devices, pharmacovigilance, and applications for marketing authorizations have been impacted.

Regulatory reforms and UK approval pathways for medicinal products and devices.

Joint regulatory reforms of the MHRA, together with the health technology institute, National Institute for Health and Care Excellence (NICE), announced in the Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025, are set to speed up medicine approvals. Noteworthy developments are as follows:

• Personalized medicines. From July 2025, MHRA will permit point-of-care manufacturing of personalized medicines. It should be noted that in the EU there are concerns about ensuring appropriate oversight of such medicines. Proposed amendments to the medicinal products directive have previously sought to restrict the “hospital exemption,” permitting hospital-based small scale preparation of personalized medicines. The European Medicines Agency has also warned that unregulated personalized therapies carry a risk of inconsistent product composition.
• Technology Appraisals. NICE aims to complete 60% of Technology Appraisals within 240 working days by 2025/26.
• Reduced approval times. The Innovative Licensing and Access Pathway (ILAP) will provide access to an integrated scientific advice service, as well as concurrent marketing authorization and technology appraisal processes, to reduce approval times for new medicines. For further detail on the ILAP, please see our previous blog post here.

In addition, a number of initiatives and pathways are available within the biotechnology and pharmaceutical ecosystem of the UK, with the stated aim of streamlining regulatory processes for the benefit of the industry. These could potentially be utilized for positive commercial effect by U.S.- and EU-based life sciences companies that have a corporate strategy of looking to launch and market products in the UK. Regulatory pathways available in the UK which may be of interest to international pharmaceutical, biotech, and medical devices companies include:

• The International Recognition Procedure. This pathway could potentially be exploited to greater effect by a larger number of companies. It allows a UK marketing authorization (MA) for a medicinal product to be obtained without the need to adhere to the full regular MA process. This may be permitted where an equivalent authorization for the same product has been granted by an MHRA-approved regulatory body in another jurisdiction. Currently, regulators are approved in Australia, Canada, Switzerland, Singapore, Japan, the U.S., and the EU.
• Pre-Submission Advice allows prospective marketing authorization applicants to meet with MHRA and discuss their applications before making a formal submission. It is available for applications via the International Recognition Procedure and for new active substance/complex indications.
• NICE Patient Access Schemes allow for confidential or non-confidential discounts to be applied to products which would otherwise not be considered cost-effective by NICE. An overview of patient access schemes can be found here.

In some notable instances, the UK has demonstrated its expeditiousness, relative to the EU, in respect of issuing approval for new medicines. For example, in March 2025, the MHRA approved a ground-breaking product used to detect certain cancerous lesions in what is being seen as a world-first. Also in March, it was reported that an orphan drug treating an ultra-rare immune disorder had secured reimbursement in England from NICE, following its participation in the NICE Patient Access Scheme. Although the orphan drug in question has also secured approval for marketing in the U.S. and Israel, its reimbursement in England was viewed as providing a favorable contrast with the protracted regulatory review which the product is undergoing in the EU.

It is important, however, to consider any new opportunities for potentially faster regulatory approval and patient access that could become available in the UK in the context of accompanying new legal and regulatory specificities required for approvals and commercialization in the country. These specificities are generally bringing the UK’s regime closer to that of the EU. For example, although the new clinical trials regulation is primarily aimed at reducing the regulatory burden, it will also impose some new requirements, particularly in the area of transparency. These include a requirement to offer participants a summary of trial results, written in a manner understandable to lay persons, within 12 months of the trial’s end. A new post-market surveillance (PMS) regulation for medical devices will also come into force in June 2025. The PMS regulation will impose requirements for additional data collection and shorten timelines for serious incident reporting.

This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.