Industrial Policy & Trade Monitor· 2663 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.

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.