European Pharma Regulations: 2024 Review and 2025 Trends to Watch

Gaining a Competitive Edge: 2024's European Pharma Regulatory Review & Trends to Look for in 2025 and Beyond

As the pharmaceutical landscape in Europe evolves rapidly, regulatory frameworks are adapted to accommodate the increasing complexity of drug development, particularly for innovative products such as biologics, advanced therapies, and digital health solutions. With regulatory agencies in the European Union (EU), United Kingdom (UK), and Switzerland continuing to refine their approaches, pharmaceutical developers seeking to enter these markets must stay informed of the latest updates and anticipate future requirements.

At ProPharma, we specialize in helping global pharmaceutical companies navigate the intricacies of the European market. This blog explores the most significant regulatory developments in 2024, offering insights into the opportunities and challenges for companies aiming to bring innovative products to the EU, UK, and Switzerland. We also highlight anticipated changes for 2025, including the Health Technology Assessment Regulation (HTAR) and new AI-related regulations, that every developer must be aware of.

EU: Paving the Way for Innovation in Medicine

The European Medicines Agency (EMA) and the European Commission have been instrumental in shaping the regulatory environment for innovative therapies in Europe. In 2024, the focus remained on enhancing patient access to breakthrough treatments while ensuring that safety and efficacy standards are upheld. The following developments are particularly relevant for developers of novel drugs and therapies.

Advanced Therapy Medicinal Products (ATMPs)

The EU continued to prioritize the development of Advanced Therapy Medicinal Products (ATMPs), which include gene therapies, cell therapies, and tissue-engineered products. These therapies represent some of the most exciting innovations in modern medicine, yet they pose unique regulatory challenges. In 2024, the EMA introduced several updates to facilitate the development of these therapies:

• PRIME (PRIority MEdicines) Scheme Expansion: This initiative is designed to provide early and intensified support for products that offer significant benefits to patients with unmet medical needs. In 2024, an increasing number of ATMPs received PRIME designation, which allows for accelerated clinical development and a faster route to market.
• Revised ATMP Guidelines: The EMA released updated guidance on the manufacturing and quality control of ATMPs. This includes more detailed recommendations on risk-based approaches to ensure safety and regulatory compliance, which are crucial for products that often involve complex biological systems.

These changes reflect the EU's commitment to ensuring that innovative therapies reach patients more swiftly, without compromising safety standards.

Artificial Intelligence and Digital Health Regulations

In 2024, we saw significant progress in the regulation of AI-based technologies in the pharmaceutical and healthcare sectors. As the use of AI in drug development, diagnostics, and patient management grows, the EU is taking steps to ensure that these technologies are safe, effective, and transparent.

• Medical Device Regulation (MDR) and In-vitro Diagnostic Regulation (IVDR): These regulations govern the use of AI in medical devices and diagnostics. In 2024, the EMA and other EU bodies focused on the application of these regulations to AI-driven products, offering clearer pathways for AI-based devices that assist in clinical decision-making or drug discovery
• AI Act (Upcoming): The EU AI Act, set to be finalized in 2025, will establish a comprehensive regulatory framework for AI applications across sectors, including healthcare. Pharmaceutical developers working on AI-driven therapeutics or diagnostics must prepare for these changes, which will require increased transparency and accountability in AI models.

Sustainability and the Green Deal

Environmental sustainability is becoming an increasingly important consideration in pharmaceutical development. In 2024, the European Commission strengthened its focus on reducing the environmental impact of pharmaceuticals. This includes new guidelines under the European Green Deal, which will influence the production, packaging, and disposal of drugs. Pharmaceutical companies entering the European market will need to align their operations with sustainability standards, particularly as regulations tighten in 2025.

UK: Embracing Innovation with Agility and Flexibility

Post-Brexit, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has worked to establish an independent regulatory framework that emphasizes flexibility and rapid approval for innovative therapies. The UK remains an attractive market for pharmaceutical developers, particularly those with groundbreaking treatments.

Innovative Licensing and Access Pathway (ILAP)

One of the standout features of the UK regulatory landscape is the Innovative Licensing and Access Pathway (ILAP), which was enhanced in 2024. The ILAP offers an expedited route to market for innovative products, particularly those targeting rare or life-threatening conditions. Through ILAP, companies can benefit from:

• Early scientific advice from the MHRA, which helps developers understand the regulatory requirements for their products.
• Rolling reviews of clinical data, allowing for faster decisions based on partial data sets.
• Closer engagement with payers and healthcare systems, ensuring that pricing and reimbursement decisions align with the value proposition of the product.

Project Orbis

In addition to ILAP, the MHRA participates in Project Orbis, an international collaborative program coordinated by the U.S. Food and Drug Administration (FDA). Project Orbis provides a framework for concurrent submission and review of oncology products among international partners, aiming to deliver faster patient access to innovative cancer treatments that provide potential benefits over existing therapies. The MHRA's involvement in Project Orbis complements ILAP by facilitating the rapid assessment and approval of promising oncology therapies, thereby broadening the avenues through which innovative treatments can reach patients in the UK.

These initiatives collectively enhance the UK's attractiveness as a market for pharmaceutical developers, particularly those focused on groundbreaking treatments, by providing a supportive and responsive regulatory environment.

AI Regulation and Digital Health

The UK has also been proactive in addressing the regulatory challenges posed by AI and digital health technologies. As the use of AI in drug development and healthcare diagnostics grows, the MHRA is focused on developing frameworks that ensure AI-based products are safe, transparent, and ethical.

• The AI Strategy, introduced by the UK government, outlines how AI will be integrated into healthcare applications. Developers working on AI-driven diagnostics or treatments need to keep a close eye on upcoming legislation, particularly the anticipated UK AI Regulation in 2025, which will complement the EU's AI Act.

Windsor Framework

The implementation of the Windsor Framework, which took effect on January 1, 2025, introduces new arrangements for the supply of medicines in Northern Ireland. Under this framework, the MHRA licenses all medicines on the UK market, including those in Northern Ireland, under a UK-wide marketing authorisation. A significant requirement is that all medicines must carry a 'UK Only' label or sticker, indicating they are solely for sale within the UK and not in European Union countries. The MHRA has issued guidance to marketing authorisation holders to ensure compliance with these new packaging and labelling measures by the 31 December 2024 deadline. Transition measures allowed medicines released to the market before January 1, 2025, to be supplied without the new labelling until they reach their expiry date.

Switzerland: Regulatory Alignment and Continued Support for Innovation

Switzerland, though outside the EU, maintains a strong relationship with European regulatory bodies, particularly the EMA, due to its membership in the European Free Trade Association (EFTA). The country continues to align closely with EU regulations, facilitating smoother market access for products approved by the EMA.

Support for ATMPs and Biologics

In 2024, Switzerland continued to build on its strong support for ATMPs and biologics through Swissmedic. Like the EU, Swissmedic has been refining its regulatory framework to ensure that cutting-edge therapies can be brought to market quickly and efficiently.

• Temporary Authorization: Swissmedic allows for Temporary Authorization, similar to the EMA’s conditional market authorizations, which permit early access to medicines that address urgent unmet needs. This is particularly relevant for innovative products such as gene therapies and cell-based treatments, which often involve lengthy and complex development timelines.

Switzerland's Harmonization with EU Standards

Switzerland's commitment to regulatory harmonization with the EU is expected to remain strong, with Swissmedic continuing to adopt EMA guidelines for biologics, biosimilars, and advanced therapies. As such, companies seeking approval in both Switzerland and the EU will benefit from aligned regulatory requirements, ensuring a smoother market entry process.

Anticipated Developments in 2025 and Beyond: What to Expect

This year, pharmaceutical developers must be prepared for several key regulatory developments that will impact market entry strategies in Europe:

Health Technology Assessment Regulation (HTAR)

One of the most significant changes on the horizon is the full implementation of the Health Technology Assessment Regulation (HTAR) in the EU. Scheduled to take effect in 2025, HTAR will streamline and harmonize the assessment of new treatments across EU member states. Key changes include:

• Joint clinical assessments across EU countries, reducing duplication and speeding up decision-making.
• Payer engagement: HTAR will integrate economic considerations into the regulatory process, including cost-effectiveness evaluations.
• Impact on pricing and reimbursement: Developers will need to ensure that their clinical evidence supports both the therapeutic benefit and the economic value of their products.

Pharmaceutical companies must ensure their regulatory submissions are supported by robust data demonstrating both clinical efficacy and value for money, as HTAR will influence pricing and reimbursement decisions across Europe.

AI Act (EU) and UK AI Regulations

With the AI Act in the EU and anticipated AI regulations in the UK, pharmaceutical developers working with AI-driven products will face stricter requirements for transparency, safety, and data protection. In 2025, AI-based medical devices and treatments will need to comply with these new regulations, which will include more rigorous pre-market assessments and ongoing monitoring requirements.

Looking Forward to EMANS 2028

The EMA and the Heads of Medicines Agencies (HMA) have released a draft of the EMANS 2028 for public consultation. This strategy builds upon the successes of the EMANS 2025 initiative, which delivered significant advancements such as the launch of DARWIN EU, CTIS, and ACT EU. These initiatives have streamlined regulatory processes, enhanced real-world evidence capabilities, and strengthened the EU's regulatory framework.

EMANS 2028 addresses key regulatory priorities, including:

• Improving Medicine Accessibility: Facilitating pathways for access to medicines through healthcare systems in the EU.
• Integrating AI: Leveraging data, digitalization, and AI to improve decision-making, optimize processes, and increase efficiency.
• Strengthening Supply Chain Resilience: Enhancing the availability and supply of medicines to protect public and animal health.

The strategy also focuses on regulatory science, innovation, competitiveness, antimicrobial resistance, and the sustainability of the network. The final strategy is expected to be adopted by HMA and EMA in March 2025.

Incorporating the objectives of EMANS 2028 into strategic planning is essential for sponsors operating within the EU. Building on the foundation laid by EMANS 2025, EMANS 2028 is poised to further shape the regulatory landscape, offering opportunities to align with evolving priorities, ensure compliance, and enhance the potential for successful market access.

Environmental Sustainability Regulations

Both the EU and Switzerland are expected to introduce stricter environmental sustainability regulations in 2025. Pharmaceutical companies will need to meet new requirements for eco-friendly drug production, packaging, and waste management, which will impact both operational costs and market entry strategies.

Navigating the Regulatory Landscape in Europe

2024 was a year of transformation in pharmaceutical regulations across the EU, UK, and Switzerland. With the rapid pace of innovation in biologics, gene therapies, and digital health, it is crucial for pharmaceutical developers to stay informed and prepared for upcoming regulatory changes. ProPharma is committed to helping global pharmaceutical companies navigate the complexities of European regulatory pathways, ensuring that their innovative products achieve market access quickly and efficiently.

In 2025, developers must be ready for the implementation of HTAR, the evolving AI regulations, and stricter sustainability standards. By partnering with an experienced regulatory consultant, pharmaceutical developers can ensure they are well-positioned to meet these challenges and successfully enter the European market with their cutting-edge products.

ProPharma's team of expert regulatory affairs consultants has extensive expertise in navigating the complex European regulatory landscape. We are fully equipped to support pharmaceutical development companies aiming to enter the European market. Our team offers comprehensive guidance through the regulatory pathway, ensuring your strategy remains efficient and agile by staying informed of the latest European initiatives.