Industrial Policy & Trade Monitor· 2668 actions· ✨ 89 recent

In the early hours of 11 December 2025 the Council of the EU and the European Parliament reached provisional political agreement in trilogue on the "EU Pharma Package" — the revised pharmaceutical Regulation (COM 2023/0131) and Directive (COM 2023/0132) — the most significant overhaul of EU pharmaceutical legislation in over two decades. The package replaces Directive 2001/83/EC (Community Code on medicinal products for human use) and Regulation (EC) 726/2004 (the EMA Regulation), and consolidates the orphan-medicine (Regulation 141/2000) and pediatric-medicine regulations into a single framework. Headline provisions: (i) a new "8+1(+1)(+1)" IP-incentive architecture — 8 years of regulatory data protection plus 1 year of market protection, with up to two additional 12-month extensions for products addressing unmet medical need or new active substances meeting comparative-trial conditions, capped at 11 years total; (ii) an EU-wide list of critical medicines under enhanced governance via the Medicines Shortages Steering Group (MSSG) and an EMA "list of critical shortages in the EU"; (iii) mandatory shortage-prevention plans on marketing-authorisation holders for prescription medicines and Commission-designated products; (iv) modernisation of clinical-trial requirements, environmental-risk assessment, antimicrobial stewardship, and a transferable-exclusivity-voucher (TEV) regime to incentivise novel antibiotic R&D. The COREPER I committee endorsed the compromise text on 6 March 2026 and final adoption by Parliament and Council is expected during summer 2026, with the regulatory framework becoming applicable in 2028.

The UK Department of Health and Social Care, delivered via Innovate UK, awarded more than GBP 54 million in government funding across eight R&D projects on 18 November 2025 through the Sustainable Medicines Manufacturing Innovation Programme, matched by more than GBP 20 million from industry (combined GBP 74m+). The programme is funded through the GBP 400 million VPAG Investment Programme, agreed under the 2024 Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG), and supports the manufacturing pillar of the UK's Modern Industrial Strategy Life Sciences Sector Plan. Funded projects include anaesthetic gas recovery/recycling (targeting ~GBP 5m annual NHS savings), converting spent nuclear fuel into radionuclide cancer therapies, CAR-T cell manufacturing scale-up (Royal Free Hospital), engineered bacteriophages for antibiotic resistance, and an AstraZeneca-led "Sustainable Future Factory" AI/robotics initiative.

China's State Council promulgated Order No. 818 on 28 September 2025 (effective 1 May 2026), establishing a comprehensive dual-track regulatory framework for biomedical new technologies — defined as techniques operating at the cellular or molecular level not yet clinically applied in China, covering cell therapy, gene editing, CAR-T, stem-cell, xenotransplantation, brain-computer interfaces, and nucleic-acid therapies. The regulation creates two parallel pathways: a traditional NMPA drug/device registration route and a new NHC-supervised clinical-research-to-commercialization track applicable to highly personalised or rare-disease therapies meeting staged safety and efficacy thresholds. Commercialisation under the NHC track is initially restricted to accredited Grade-3A medical institutions without full NMPA marketing approval, potentially accelerating patient access for qualifying technologies by 5–8 years relative to the standard registration pathway.

President Trump signed Executive Order 14273, "Delivering Most- Favored-Nation Prescription Drug Pricing to American Patients", on 12 May 2025. The EO directs HHS, USTR, and Commerce to pursue mechanisms (negotiation targets, importation pathways, and trade-policy levers) to bring the prices Americans pay for innovative prescription drugs into alignment with the *lowest* prices paid by other comparably-developed nations — the "most-favored-nation" (MFN) benchmark. Unlike the Biden-era Inflation Reduction Act drug-price-negotiation provisions (which apply to a handful of Medicare Part D drugs), the EO applies pressure across the broader pharmaceutical pricing surface. As of April 2026, 17 major pharmaceutical manufacturers (incl. Eli Lilly, Pfizer, Bristol-Myers Squibb, AbbVie, Merck, AstraZeneca, Regeneron) have signed bilateral agreements bringing US drug prices toward the international- benchmark level for selected medications.