Life Sciences Regulatory Outlook 2025: Areas to Watch in the U.S., EU, UK, and Asia

As a new administration takes office in the U.S., life sciences companies and investors are preparing for changes in the regulatory, compliance, and enforcement landscape. Ropes & Gray hosted a webinar on January 28, 2025, where partners from our global life sciences and regulatory compliance practice group discussed significant regulatory developments that are expected to impact the life sciences sector in 2025. This Viewpoint summarizes key takeaways from last week’s discussion.

United States

• President Trump nominated Robert F. Kennedy, Jr. for Secretary of the U.S. Department of Health and Human Services (HHS). Kennedy is a well-known skeptic of vaccines and has promised to closely analyze the data supporting vaccine safety.  How his skepticism will manifest in new or changed U.S. Food and Drug Administration (FDA) policies, or changes to the government’s vaccine recommendations framework, remains to be seen. 
• President Trump nominated Dr. Marty Makary, a transplant surgeon and public policy researcher, to be FDA Commissioner. Makary has criticized the FDA’s handling of the COVID-19 pandemic.  He has also criticized food and health care standards that he blames for contributing to chronic diseases and has taken issue with the “over-medication” of Americans. 
• Significant leadership changes and potential staff reductions at FDA—whether the result of efforts by the Department of Government Efficiency or otherwise—could impact the agency’s ability to review medical products and maintain morale in the coming year.
• We anticipate the Trump administration will deprioritize or undo the implementation of the FDA’s controversial laboratory-developed test (LDT) rule, which the Biden administration promulgated to phase in regulation of LDTs as medical devices.
• Conversely, we expect the Trump administration to continue supporting initiatives like the accelerated approval framework and other policies that encourage product development for rare diseases.
• The new administration is also likely to continue implementing a flexible framework for FDA regulation of artificial intelligence following on recent guidance on AI-based medical device software issued by the outgoing Biden administration.
• Predicting the new administration’s stance on other matters is more challenging. It remains unclear, for example, if and how the incoming leadership’s vocal critiques of DTC drug advertising will influence policy in the new administration, or how the new administration’s focus on chronic disease will impact agency priorities and programming. There is so far no outward sign of FDA diminishing its ongoing engagements and partnerships with foreign governments or regulatory coalitions, among others, on various international initiatives to safeguard public health and patient safety. That said, the recent announcement of the U.S.’s intention to withdraw from the World Health Organization will likely cause enormous strain on the global public health community.

European Union and United Kingdom

• The EU is undergoing a major revision of its general pharmaceutical legislation, last updated in 2004, to consolidate various legal instruments and achieve key policy objectives such as improving patient access to medicines, enhancing supply chain security, promoting innovation, ensuring environmental sustainability, and addressing antimicrobial resistance. The legislative proposal has passed its first reading in the European Parliament with certain key amendments and will require the European Council’s approval. The proposal is projected to be adopted by 2026. 
• The Health Technology Assessment Regulation (HTA) Regulation introduces a harmonized Joint Clinical Assessment procedure across the EU to evaluate the relative effectiveness of new medicines and medical devices compared to existing alternatives to guide health economic assessments. Starting in January of this year, all new oncology products and advanced therapy medicinal products will be required to undergo this process. This requirement will be extended to all orphan medicinal products by 2028. On January 24, 2025, the European Commission adopted detailed procedural rules on joint scientific consultations on medical devices and in vitro diagnostic medical devices. 
• Regulators are developing digital health policies focused on secure data access, sharing health data for research, and personalized care through digital services. The EU’s AI Act intersects with medical device regulations, applying a risk-based framework, while the UK has adopted a cross-sector, outcome-based framework for AI regulation underpinned by several core principles such as safety, security and governance.
• Additionally, both the EU and UK are undergoing reforms to their regulation of medical devices. The EU is addressing certification delays, burdens on SMEs and divergent interpretation of the legal requirements in the implementation of the Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR). The European Parliament has called for urgent revisions to these Regulations, emphasizing that any changes to existing rules or new rules must be accompanied by appropriate transition periods to ensure smooth adaptation to any legislative changes and reduce administrative burdens. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) is updating the UK Medical Devices Regulations (UKMDR) in stages, with the first statutory instrument on post-market surveillance laid before Parliament in October 2024. A public consultation on pre-market requirements was launched in November 2024, focusing on international reliance, UKCA marking, and the classification of in vitro diagnostic devices. Further updates to the UKMDR are expected throughout 2025.

China, Japan, and India

• The State Council of China has announced policy incentives to reform the life sciences industry. Proposed changes would facilitate the partial outsourcing of manufacturing activities to Chinese facilities by foreign companies, reducing the barrier to cross-border licensing collaborations. Additionally, China is considering amendments to its Medical Device Administrative Law (MDAL) that would raise the penalties for failing to comply with compulsory product standards, particularly if the products are high-risk implants or cause bodily damages.
• In an effort to reduce drug lag, Japan’s government is engaging in a rulemaking that would allow drugs to seek approval absent a clinical study in Japan under certain circumstances, though safety and efficacy would need to be studied in Japan post-approval. Japan is also working to amend its Act on Pharmaceutical and Medical Devices (the PMD Act). In addition to changing enforcement and penalties, the current Bill includes funds to ensure a consistent supply of generic medicine and to support innovative drug development. The Japanese government has also allocated $300 million to digital technologies and AI and updated the approval process for software as a medical device (SaMD). Starting in 2024, certain SaMD products have been able to receive provisional approval for narrow indications, followed by broader approval after additional data collection.
• India is undergoing significant regulatory reform in the life sciences sector to simplify regulation, enhance efficiency, and ensure high safety and quality standards. The Central Drugs Standard Control Organization (CDSCO) is seeking industry input on certain proposed changes and has directed makers of sterile equipment to comply with Good Manufacturing Practices (GMP) under Schedule M of the Drugs and Cosmetic Rule. By the end of 2025, CDSCO will require both sterile equipment manufacturers and small pharmaceutical companies to adhere to these GMP standards, which currently apply only to drug manufacturers.

Further information

Ropes & Gray’s FDA Regulatory, European Life Sciences, and Asia Life Sciences teams will continue to closely monitor developments throughout 2025. If you have any questions about this piece or are interested in attending any of our upcoming events, please reach out to one of the attorneys listed below or your usual Ropes & Gray advisor.

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