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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

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 April and early May 2025 from the United States, United Kingdom, and European Union.

Cybersecurity is a hot topic in the UK and EU this month. In both, cybersecurity plans are developing, with the European Commission conducting a consultation on the EU Action Plan to strengthen cybersecurity within hospitals and health care providers, and the UK Cyber Security and Resilience Bill being published, introduced partly because of cyberattacks on UK hospitals. This is clearly an important area for developers of digital products and services, who should watch the progress of these policies closely.Continue Reading Virtual and Digital Health Digest – May 2025

The current EU regulatory landscape for biotechnology is widely viewed as insufficient to be able to exploit the full potential of such technologies. Regulatory hurdles exist at EU and Member State level, and this is thought to have driven investment into other regions.

To help tackle this problem, the introduction of a new EU Biotech Act (the Act) has been proposed by the Commission to encourage innovation in areas such as health technology assessment and clinical trials. A simpler regulatory landscape, with no reduction to safety standards, will be a central aim of the Act.

However, it was announced on 20 March 2025 that the Act has been delayed until the third quarter of 2026 (initially due in the last quarter of 2025). As such, it remains to be seen what shape the Act will take, including whether any changes will be limited to setting out general guidelines, or whether it will take the form of a binding legal instrument, imposing specific measures to which Member States and EU institutions must adhere. Various studies and papers have been developed following the announcement of the proposed Act, and it is hoped that as these are finalised, they will provide further insight into what we can expect.Continue Reading EU Biotech Act– what we know so far

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 March and early April 2025 from the United States, United Kingdom, and European Union.

The biggest change this month is that as of March 25, 2025, the European Health Data Space Regulation (EHDS Regulation) is now in force. This means that, as it is gradually implemented, companies will be able to request access to electronic health data for health care purposes, including for use in scientific research, and may be required to share certain health data that they hold. The implementation of the EHDS Regulation is likely to raise a number of questions, which future European Commission implementing regulations or guidelines may clarify.Continue Reading Virtual and Digital Health Digest – April 2025

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 February 24, 2025, new rules came into force in the UK transforming the public procurement landscape. The new regime aims to provide a simplified and flexible framework for contracting authorities when conducting procurement processes, including the purchase of medicinal products by the National Health Service (NHS).

Under the new Act, a number of elements of the procurement processes have changed, and we set out the background in our previous post. For tenderers, the changes are mainly procedural, including the framework for the tender process and the timelines, rather than fundamental changes to how the procurement will operate. Nevertheless, it is important to take note of the new procedures. We set out some of the key aspects in our Advisory. Continue Reading UK Public Procurement Landscape Transformed: What Does It Mean for Medicines?

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 February and early March 2025 from the United States, United Kingdom, and European Union.

Artificial intelligence (AI) has been the focus this month, with certain aspects of the EU AI Act now in force and key guidance being published by the European Commission. In addition, the much criticized AI Liability Directive has been withdrawn by the European Commission. In the UK, the UK government published its AI Action Plan setting out its proportionate, flexible regulatory approach towards AI, and the Medicines and Healthcare products Regulatory Agency (MHRA) hosted an Innovation Showcase demonstrating how it is using digital technologies and AI throughout the regulatory lifecycle. Continue Reading Virtual and Digital Health Digest – March 2025

We recently published this Advisory for our US clients, but thought it may be a useful reminder for UK and EU teams given the number of updates in this area.

We are sure that you are aware that the European Union (EU) medical devices framework has been subject to significant changes over recent years. However, implementation of the new rules has been problematic since the beginning, as both the industry and the EU institutions, national authorities, and notified bodies have found it difficult to adapt to the stricter and demanding new legal requirements. There are ongoing delays in companies obtaining CE marks under the new regime, criticism that the rules are stifling innovation, and concerns about the impact on patients.

Given the calls for change, criticism, and ongoing consultations, this Advisory sets out the current status of developments and what is important to know when seeking to do business in the EU.Continue Reading EU Medical Devices Legislation: What You Need To Know Given Latest Developments and Ongoing Challenges

UK Prime Minister Kier Starmer announced yesterday that NHS England will be abolished to “cut bureaucracy” and bring management of England’s health service “back into democratic control”. NHS England will be brought back into the Department of Health and Social Care (DHSC) over the next two years.

The Government aims to remove a “burdensome layer of bureaucracy” and “put an end to the duplication resulting from 2 organisations doing the same job”. In doing so, the intention is to save hundreds of millions of pounds, enabling funds to be channelled towards enhancing patient care, reducing waiting lists and increasing staff salaries.  However, exactly how this will be done and what impact this will have on patients, staff and the many partners of the NHS in England, including pharmaceutical companies, is not yet known.Continue Reading UK Prime Minister Announces that NHS England will be abolished

On 6 February 2025, EU Member States announced the launch of a new pilot scheme for coordinated assessment of clinical investigations of medical devices (CI) and performance studies for in vitro diagnostic (IVD) medical devices (PS). Supported by the European Commission, the pilot allows sponsors to submit a single CI or PS application for review across multiple Member States, rather than each Member State conducting independent standalone reviews. The pilot scheme aims to make the application process for multi-national CI and PS more efficient and to reduce the duplication of activities by both the sponsor and competent authorities. As this has been a major cause of delays and complications in conducting CIs, this pilot will be welcomed by industry.Continue Reading EU announces pilot coordinated assessment for clinical investigations of medical devices