Industrial Policy & Trade Monitor· 2665 actions· ✨ 90 recent

On 8 May 2026 China's National Health Commission released a public consultation draft proposing material amendments to the 2023 Implementation Rules for the Administrative Regulations on Human Genetic Resources, with a comment deadline of 7 June 2026. The draft narrows the statutory "foreign party" definition to a bright-line 50% equity/voting threshold (excluding VIE-structured entities), restricts "HGR Information" strictly to nucleic-acid sequence data (excluding clinical, imaging, and metabolic data), removes the separate Article 37 security-review requirement for sensitive HGR datasets, and introduces a same-day or next-working-day fast-track confirmation for international clinical trials not involving HGR information export.

The Office of the United States Trade Representative released the 2026 Special 301 Report on 30 April 2026, designating Vietnam as a Priority Foreign Country (PFC) — the most severe category under Section 182 of the Trade Act of 1974 (19 U.S.C. § 2242). This is the first PFC designation since Ukraine held the status from 2013 through 2015, a gap of approximately 11 years. The PFC designation triggers a statutory 30-day window (expiring ~30 May 2026) within which USTR must decide whether to initiate a Section 301 investigation under 19 U.S.C. § 2412(b)(2)(A), which could lead to tariffs, withdrawal of trade benefits, or other Section 301 enforcement remedies against Vietnam. Separately, the EU was added to the Watch List for the first time, citing AI training-data, geographical-indications, and customs-enforcement concerns.

Premier Li Qiang signed State Council Order No. 834 on 31 March 2026 promulgating the "Provisions on Industrial Chain and Supply Chain Security" (18 articles), adopted at the State Council executive meeting on 13 March 2026 and effective on the date of publication. The Provisions are the first dedicated PRC administrative regulation on industrial- and supply-chain security and consolidate authorities drawn from the National Security Law, Foreign Relations Law, Anti-Foreign Sanctions Law, and Foreign Trade Law into a horizontal defensive framework. They establish a cross-agency coordination mechanism spanning roughly 15 central departments (industrial, security, cyberspace, customs and financial regulators) plus provincial governments; create a security-investigation system; and vest broad countermeasure authority over both foreign states (Article 14 — import/export prohibitions and special levies) and foreign organisations and individuals (Article 15 — import/export bans, China-investment bars, transaction prohibitions, entry bars and revocation of work or residence permits, with extension to effectively-controlled subsidiaries). The Provisions also impose compliance, information-sharing, strategic-reserve and emergency-response obligations on PRC organisations and individuals, and authorise requisition, mandated production and directed transportation in the event of supply-chain disruption.

Section 851 of the FY 2026 National Defense Authorization Act (P.L. 119-60), signed December 18, 2025, prohibits US federal agencies from procuring biotechnology equipment or services from designated "biotechnology companies of concern" (BCCs), and bars federal contractors from using such equipment/services in work performed under federal contracts, grants, or loans. The final enacted text ties initial BCC designations to DoD's existing §1260H Chinese-military-company list (which currently includes BGI and MGI, but not WuXi AppTec or WuXi Biologics) and directs OMB to designate additional BCCs within one year of enactment; operational prohibitions activate 60-90 days after FAR revision, with a five-year grandfather period for pre-existing contracts — enforcement is expected to begin in 2027-28. The legislation is the successor to H.R.8333 (118th Congress, House-passed September 2024 but stalled in the Senate before adjournment) and represents the first enacted US federal-procurement biotech-supply-chain-resilience statute.

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.

Minister of Trade Regulation No. 20 of 2025, signed by Minister Budi Santoso on 30 June 2025 and effective 29 August 2025 (60 days after promulgation), reorganises Indonesia's import regime for chemicals, Hazardous Materials (B2), and a defined set of mining and energy inputs. The regulation revokes Permendag 8/2024 and requires holders of designated importer status (Importir Terdaftar / Importir Produsen) to secure an Import Approval (Persetujuan Impor) plus a post-arrival Surveyor Report (Laporan Surveyor) for an eleven-cluster commodity bundle including lubricant raw materials, cement clinker and cement, rough diamonds, non-pharmaceutical precursors, crude oil and natural gas, nitrocellulose, commercial-industrial explosives, ozone-depleting substances, hydrofluorocarbons, B2, and certain other chemicals (BKT). It is one of nine commodity-cluster Permendags issued the same day under the Prabowo administration's umbrella import-policy deregulation package.

Japan's National Diet passed a partial amendment to the Pharmaceutical and Medical Device Act (PMD Act / 薬機法) on May 14, 2025, promulgated as Law No. 37 of 2025 on May 21. The amendment requires every Marketing Authorization Holder (MAH) to designate a Supply System Manager responsible for reporting supply disruptions to MHLW, and grants MHLW authority to order replacement of key quality personnel when systemic deficiencies are found. It also reforms GMP oversight to a risk-based inspection model and expands the conditional-approval pathway for rare disease and paediatric drugs. Enforcement is staggered across three tranches: November 2025, May 2026, and final full implementation by May 2027.

The U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC) issued a final rule amending three sanctions programs. The rule adds a new general license at 31 CFR § 525.512 to the Burma Sanctions Regulations authorizing the provision of agricultural commodities, medicine, medical devices, replacement parts and components for medical devices, and software updates for medical devices to individuals whose property and interests in property are blocked. It also updates the authorities section of the Burma Sanctions Regulations to reflect recent legislation, replaces "the Office of Foreign Assets Control" / "the Director of the Office of Foreign Assets Control" with the acronym "OFAC" in three sections of the Sudan Stabilization Sanctions Regulations, and corrects a cross-reference in the Ukraine-/Russia- Related Sanctions Regulations. The rule is effective on publication.

Belgium's Loi du 29 février 2024 (published in the Moniteur Belge on 27 May 2024, entering into force 1 June 2026) establishes the first comprehensive federal authorisation and traceability regime for pharmaceutical raw materials used by pharmacists in extemporaneous and magistral preparations. Manufacturers, importers, and distributors of covered materials must obtain AFMPS authorisation and comply with Good Manufacturing Practice and Good Distribution Practice standards; pharmacists may only source materials from authorised actors. The statute was enacted during Belgium's EU Council Presidency (H1 2024) and directly parallels the EU Critical Medicines Alliance architecture launched in Leuven on 24 April 2024, positioning Belgium as the first EU member state to operationalise a national supply-chain control layer for pharmaceutical compounding raw materials ahead of the forthcoming EU Critical Medicines Act.

Russian Government Resolution No. 506 of 29 March 2022, signed by Prime Minister Mikhail Mishustin and effective 30 March 2022, authorises the Ministry of Industry and Trade (Minpromtorg) to designate categories of goods exempt from articles 1252(4), 1359(6) and 1487 of the Russian Civil Code on national/regional exhaustion of trademark and other intellectual- property rights. Followed by Minpromtorg Order No. 1532 of 19 April 2022 publishing an initial list of 55 goods categories and named brands — including pharmaceuticals, electronics, automotive parts, mineral fuels, industrial chemicals, paper, textiles, base metals, and consumer goods — for which parallel (grey-market) imports without IP-holder consent are legalised. Designed as a sanctions-circumvention and supply-substitution instrument after the Western corporate exodus of March 2022; extended annually and most recently re-authorised through 31 December 2026.

The Bureau of Industry and Security (BIS) amended the Chemical Weapons Convention Regulations (CWCR, 15 CFR Part 710) and Export Administration Regulations (EAR, 15 CFR Parts 712 and 745) to implement two OPCW Conference of States Parties decisions (C-24/DEC.4 and C-24/DEC.5) from November 2019. The rule adds four chemical families — two families of alkyl phosphonamidic fluorides, O-alkyl phosphoramidofluoridates, and quaternary/bisquaternary carbamates — to CWC Schedule 1(A), effective immediately upon publication. The rule also clarifies the definition of "production" in 15 CFR § 710.1 to include intermediates, by-products, and waste products generated within a defined manufacturing sequence.