DLRC Achieves Cyber Essentials Plus Certification
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Navigating Regulatory Uncertainty: Brexit, FDA Changes & EU CTR
Published 25th March 2025
Throughout the years the pharmaceutical and biotechnology industries have witnessed times of regulatory uncertainty. Uncertainty can be caused by changes in regulations and government policies to shifting of political leaders. In this article we will dissect different cases of regulatory uncertainty within key markets. We look at the UK, US and EU and discuss how DLRC is well equipped to develop a strategic and efficient path to market.
Brexit Impact: How UK Regulatory Changes Affect Pharma Companies
The United Kingdom (UK) departing the European Union (EU) on January 31st 2020 has had profound implications – particularly for pharmaceutical and biotechnology companies. This political decision significantly affected the role of the Medicines and Healthcare products Regulatory Agency (MHRA). As a result of Brexit, the MHRA became an independent national regulator, separate to the European Medicines Agency (EMA). Therefore, the MHRA’s responsibilities and regulatory framework have been greatly impacted. For companies, UK’s change in status as a non-EU Member State has meant adjustment in supply chains and transfer of responsibilities for their products. There have been several notable challenges as a result of the regulatory uncertainty caused by Brexit.
MHRA Innovation: New Pathways in Post-Brexit UK Market Access
Becoming an independent national regulator allowed the MHRA to strengthen its role in the regulation of medicines, medical devices and clinical trials in the UK. The introduction of the UK Medicine and Medical Devices Act 2021 permitted the UK Government to create and enforce regulations for medical devices and pharmaceuticals independently of the EU legal framework. Whilst the UK remains closely aligned with the EU pharmaceutical legislation, this Act has enabled the UK to implement regulatory processes differing from the EMA.
Expedited processes for certain medicines, such as the Innovative Licensing and Access Pathway (ILAP) have been introduced. This is a beneficial process which aims to speed up the access of life-saving treatment to patients in the UK. However, processes – like the ILAP – can lead to regulatory uncertainty for pharmaceutical and biotechnology companies. Navigating an ILAP application differs from the international counterparts, such as the PRIME scheme run by the EMA and Breakthrough Therapy designation with the US Food and Drug Administration (FDA). The UK life sciences sector also benefits from novel approaches. An enabling framework for decentralised manufacturing was written into UK law in January 2025. It is the first such scheme globally. DLRC has expertise in key interactions with each Agency and is fully equipped to support with applications.
UK Marketing Authorisation: Navigating New Application Requirements
Since Brexit, companies must obtain a separate marketing authorisation from the MHRA for the UK market, separate from the EMA. This has created uncertainty for businesses that are familiar with the EU’s standardised processes. In particular, the special status for Northern Ireland which means it occupies a middle ground between UK and EU rules.
Prior to Brexit, companies were able to apply to the EMA for a single centralised marketing authorisation. This would allow for their products to be marketed in all EU member states. The need for a separate application for the UK has implications. For example, additional time, costs and disruption of EU-wide supply strategy. Understanding of different labelling, packaging and documentation in each market can be challenging for companies. The experts at DLRC can help you navigate this process, making it more efficient and effective.
Clinical Trials: UK’s Evolving Framework After Brexit
Clinical trials in the EU are regulated by the Clinical Trials Regulation (CTR). However, this regulation no longer applies to the UK. Therefore, since Brexit, there has been uncertainty for companies who wish to initiate a clinical trial in the UK.
Clinical trials in the UK must follow The Medicines for Human Use (Clinical Trials) Regulations 2004 and The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006, although these frameworks are under review. DLRC experts are familiar with these regulations, remain up to date with the changing requirements and are confidentially able to support Clinical Trial Applications in the UK. We can also provide legal representation for trials, both in the UK and EU.
MHRA has adapted to its changing status outside of the EU and has remained aligned with the EU pharmaceutical law in most respects. However, the MHRA has the flexibility to legislate differently after Brexit. This provides stability and certainty to pharmaceutical companies and, ultimately, prescribers and patients. We will gradually see the introduction of important innovations offering new and distinct options in the UK for pharmaceutical developers.
US Political Shifts: Trump Administration’s Impact on FDA Operations
This year introduced a new administration in the United States and saw the inauguration of Donald Trump on January 20th 2025. Recent lay-offs and instatement of leadership roles, such as Robert F. Kennedy Jr as the Secretary of health and human services, pose significant effects on the workings of the FDA. With these shifting political landscapes and evolving regulation priorities, the pharmaceutical and biotechnology sectors face a potentially unpredictable regulatory environment. For a more in-depth insight, see DLRC’s previous article ‘Trump Administration’s Impact on FDA Regulations: 5 Key Changes for Pharma & Biotech in 2025’.
Regulatory uncertainty highlights the importance of a solid regulatory strategy. When interacting with the FDA it is crucial to consider timing, priorities and approach. A strategic method will help to secure a more efficient approval process.
Special designations are often used as part of a considered approach. These include Fast Track Designations, Accelerated Approvals and Priority Review Designation. All of these routes require increased interaction with the FDA. However, in the long-term, these approaches can reduce FDA timelines for reviews. This highlights, now more than ever, with reduced FDA employees, the importance of planned and effective interactions with the FDA.
FDA Lay-offs: Practical Implications for Drug and Device Approvals
On the 15th February 2025, many employees at the FDA received emails informing them that they had been made redundant. However, it was reported that the FDA would make offers to reinstate some of these terminated employees. The lay-offs mostly affected the FDA’s Center for Devices and Radiological Health (CDRH). Although, significant impacts on medical device review and decision making have yet to be realised. The Agency’s user fee goals are described in the Medical Device User Fee Amendments (MDUFA), with the next planned review in 2027.
AI and Digital Health Technologies: Regulatory Uncertainty in FDA Oversight
Artificial Intelligence (AI) is continuously evolving and is becoming increasingly integrated into medical devices and decision making. FDA draft guidance was issued in January 2025, aiming to provide recommendation on the use of AI to support regulatory decisions, whether this be about a product’s effectiveness, safety or quality. This is the first guidance for the use of AI in product development that has been issued by the Agency. That said, novel areas like AI and digital health technologies have been affected by the recent staffing cuts. In this time of uncertainty, Sponsors should ensure that novel technologies—and challenges in the development thereof—are clearly conveyed to the Agency.
Medical Device Strategy: Navigating Reduced FDA Resources
The full effect of these redundancies is yet to be established. To mitigate any delays to bringing products to the US market, it is more important than ever to be a strong advocate for your development program. DLRC are experts in assisting with key FDA interactions, such as pre-submission meetings. We can help you to share knowledge with the Agency and receive actionable guidance and feedback.
EU Clinical Trials Regulation (CTR): Implementation Challenges and Solutions
The European Union’s (EU) implementation of the Clinical Trials Regulation (CTR) (EU No 536/2014) on 31 January 2022, marked a significant shift in the European clinical trial landscape. Replacing the clinical trial directive (CTD) (2001/20/EC), the CTR aims to harmonise clinical trial approvals across the EU, improve transparency, and enhance patient safety. Despite its intended benefits, the transition introduces a deal of uncertainty within the regulatory landscape. Much of this uncertainty arose from challenges related to the clinical trials information system (CTIS), inconsistencies in national implementation, and broader concerns about Europe’s ability to remain competitive in global clinical research.
Clinical Trials Information System (CTIS) Hurdles: Overcoming Technical and Transparency Issues
A key component of CTR is the mandatory use of the clinical trials information system (CTIS), a centralised platform designed to streamline trial submissions and assessments. The intended use of CTIS was to simplify administrative processes. However, many sponsors faced usability issues, technical difficulties, and delays in submission approvals. Reports indicate that system instability and a steep learning curve contribute to inefficiencies. Thus creating uncertainty for stakeholders navigating the new regulatory framework.
Transparency requirements under the CTR further complicated matters. The regulation mandates the public disclosure of clinical trial data, including protocols and results through CTIS. While this enhances transparency, pharmaceutical companies remain concerned about potentially exposing commercially sensitive information. Sponsors are particularly uncertain about balancing intellectual property (IP) protection with regulatory requirements, leading to hesitancy in trial submissions. Additionally, data privacy concerns have been raised concerning compliance with the EU’s general data protection regulations (GDPR). This has further complicated the regulatory landscape in the EU. DLRC’s expert regulatory consultants provide strategic guidance to sponsors. This includes navigating CTIS complexities to ensure smooth submissions and compliance with transparency requirements.
Cross-Border Trials: Managing Inconsistent EU Member State Requirements
Although the CTR was designed to create a unified approval system, national competent authorities (NCA’s) and ethics committees (EC’s) still retain a degree of discretion, leading to inconsistencies across member states. Ethical considerations, such as informed consent requirements, are subject to varied interpretations, creating administrative hurdles for multinational trials. The lack of uniformity has resulted in delays and increased regulatory burden for sponsors.
Timelines for approvals, which are meant to be standardised under CTR, have also been interpreted differently by some NCA’s. While the regulation set clear deadlines, discrepancies in implementation have led to unpredictable review periods and made it difficult for sponsors to plan trial timelines effectively. DLRC’s extensive experience put us in a strong position to support sponsors in managing these inconsistencies across member states, ensuring regulatory compliance while mitigating delays.
Strategic Support: How DLRC Navigates Regulatory Uncertainty
In this ever-evolving regulatory landscape, staying compliant while ensuring timely market access can be a complex challenge. As regulatory frameworks in the UK, EU, and US continue to shift. Whether due to Brexit, changes in CTR, or shifting leadership in regulatory agencies, navigating these uncertainties requires strategic expertise. DLRC is well-equipped to support clients challenged by these complexities. Our tailored support can combat these evolving requirements effectively.
Our expert team brings deep regulatory knowledge across multiple jurisdictions, providing strategic guidance on submissions, approvals and compliance with changing regulations. Whether ensuring smooth transitions under the EU Clinical Trials Regulation (CTR), managing UK-specific requirements post-Brexit, or adapting to FDA policy changes in the US, DLRC helps clients mitigate risks and streamline regulatory processes. We work closely with national competent authorities (NCAs), the MHRA, the EMA, and the FDA for advice and feedback on development programs, including regulatory expectations and best practices for achieving approval.
By leveraging DLRC’s strategic insights and hands-on experience, companies can confidently address uncertainty, minimise delays, and maintain compliance across key markets. With a commitment to excellence and a track record of success in addressing regulatory uncertainties, DLRC is a trusted partner in achieving regulatory clarity and accelerating product development.
