Regulatory Cooperation

Hong Kong Announces Drug And Medical Device Regulatory Reforms And New Medical Products Regulator

Hong Kong’s Chief Executive has announced major reforms to drug and medical device oversight, including a “1+” registration pathway, phased primary evaluation starting in March 2026, and a new medical products regulator to be established by the end of 2026 on the way to a fully independent evaluation framework by 2030. These changes point to faster, more autonomous approval decisions and greater use of cross-boundary clinical and real-world data, so pharma and medtech companies should plan for a distinct Hong Kong regulatory regime when allocating trials, submissions, and investment over the rest of the decade.

20 May 2026, 17:57news.gov.hkHong Kong SAR ChinaChina

OECD Webinar: Updates on PFAS Activities in Canada, China, the UK and the EU

OECD will host a June 2026 webinar where regulators and experts from Canada, China, the UK and the EU outline their latest PFAS risk-management activities and policy initiatives. The event itself does not create new legal obligations but signals continued cross-jurisdictional tightening on PFAS and offers early insight into measures that may affect chemicals and product-compliance strategies in the covered regions.

19 May 2026, 08:11oecd.orgCanadaChinaUnited KingdomEuropean Union

US OSHA Announces 2026 Virtual Public Meetings on Hazard Communication Standard and UN GHS Sessions

US OSHA has announced two virtual public meetings in June and November 2026 to gather stakeholder input on US positions for upcoming UN GHS hazard communication sessions. Companies handling hazardous chemicals should monitor these meetings and associated comment windows to help shape future changes to the OSHA Hazard Communication Standard and global GHS implementation.

15 May 2026, 14:42federalregister.govUnited States

EU Council Presidency Compromise Text on EU–Korea Mutual Recognition of Conformity Assessments

In May 2026 the Council Presidency tabled compromise text for a Decision authorising the European Commission to negotiate an EU–Korea mutual recognition agreement on conformity assessments, certificates and markings. If agreed and implemented, this MRA could significantly reduce duplicate testing and certification for EU and Korean products across multiple sectors, easing market access even though no immediate compliance changes arise at this stage.

14 May 2026, 05:56data.consilium.europa.euEuropean UnionSouth Korea

Australia TGA Adds UK MHRA-Approved Bodies to Guidance on Comparable Overseas Medical Device Regulators

In May 2026, Australia’s Therapeutic Goods Administration updated its medical device guidance to recognise UK MHRA-approved bodies as comparable overseas regulators alongside existing EU, US, Canadian, Japanese and Singaporean authorities. This widens the overseas evidence sponsors can use to support ARTG device registrations and abridged conformity assessments, potentially shortening time-to-market for UK-tested devices while leaving core legal obligations unchanged.

13 May 2026, 08:03tga.gov.auAustralia

European Parliament Public Health Committee Endorses EU–Switzerland Health and Mutual Recognition Package

In May 2026 the European Parliament’s Public Health Committee endorsed the draft EU–Switzerland agreements on health security and mutual recognition of medical products, recommending consent for an Agreement on Health and a protocol updating conformity-assessment arrangements. If finalised, the package will integrate Switzerland into EU early-warning, joint-procurement and ECDC structures and streamline mutual recognition for medical devices and pharmaceuticals, reducing duplicative oversight while preserving EU control over core legislation.

9 May 2026, 19:03europarl.europa.euEuropean UnionSwitzerland

European Parliament Public Health Committee Backs EU–Switzerland Health and Conformity Assessment Agreements

In May 2026 the European Parliament’s Public Health Committee issued a draft opinion recommending consent to the Council decision concluding a broad package of EU–Switzerland agreements on health security and mutual recognition of product conformity assessment. While the package is still pending formal approval, this signals likely integration of Switzerland into EU health-crisis frameworks and medical-product governance, so companies active in both markets should prepare for closer alignment of surveillance, joint procurement, and conformity assessment processes.

9 May 2026, 13:28europarl.europa.euEuropean UnionSwitzerland

UNECE WP.29 Circulates Proposal for Supplement 8 to UN Regulation No. 121 on Vehicle Controls, Tell-Tales and Indicators

UNECE WP.29 has circulated for its June 2026 199th session a GRSG‑adopted proposal (ECE/TRANS/WP.29/2026/120, GE.26‑05843 (E)) for Supplement 8 to the 01 series of UN Regulation No. 121, clarifying the Regulation’s scope for new vehicle categories X and Y and ADS‑equipped vehicles, aligning references to the R.E.3 Consolidated Resolution, introducing a definition of “Safety Concept” and allowing alternative requirements for some category X vehicles without a driver’s seat while refining the “passenger air bag off” tell‑tale requirement. If adopted by WP.29/AC.1 and then applied by Contracting Parties, these amendments will require OEMs and suppliers relying on UN Regulation No. 121 for type‑approval to review the scope, control‑identification design and documentation for instrument panels and controls, particularly for remotely controlled or driverless vehicles.

9 May 2026, 07:10docs.un.orgGlobal

EU Council Working Party on Technical Harmonisation To Examine Recommendation To Open EU–Korea Mutual Recognition Negotiations on Conformity Assessments

EU member state attachés in the Council Working Party on Technical Harmonisation will on 20 May 2026 examine a recommendation to open negotiations with South Korea on a mutual recognition agreement for conformity assessments, certificates and product markings. If pursued, this initiative could eventually simplify EU–Korea market access by reducing duplicate testing and certification for regulated products, though the specific sectors and conformity modules to be covered remain undefined at this stage.

8 May 2026, 06:49data.consilium.europa.euEuropean UnionSouth Korea

EU–Uzbekistan Enhanced Partnership Agreement Sets Out Chemicals Management and Product Safety Cooperation

The EU has published a binding Enhanced Partnership and Cooperation Agreement with Uzbekistan, creating a broad framework for trade, regulatory and sustainability cooperation, including product safety, market surveillance and chemicals management. Over the next several years this should drive Uzbekistan’s alignment with EU-style technical, SPS, product-safety and IP regimes, tightening compliance expectations on manufacturers, importers and agrochemical and consumer-product supply chains operating between the two markets.

5 May 2026, 06:47boe.esEuropean UnionUzbekistan

EU–Canada CETA Joint Committee Drafts Decision To Add Active Pharmaceutical Ingredients to GMP Mutual Recognition Scope

The EU–Canada CETA Joint Committee is considering a draft decision, published on 28 April 2026, to add active pharmaceutical ingredients to the scope of their mutual recognition of GMP compliance and enforcement. If adopted, this will extend existing EU–Canada GMP mutual recognition to API manufacturing, potentially reducing duplicate inspections and supporting smoother cross-border market access for pharmaceutical supply chains.

3 May 2026, 09:17eur-lex.europa.euEuropean UnionCanada

EU Council/Coreper Schedules Adoption of CETA GMP Mutual Recognition Decision on Active Pharmaceutical Ingredients

The EU Council is advancing towards adoption of its position in the CETA Joint Committee on adding active pharmaceutical ingredients to the GMP mutual recognition annex, with the item now listed for adoption at Coreper. If the Council and CETA Joint Committee complete this step, mutual recognition of GMP compliance would extend to APIs, signalling reduced regulatory friction for EU and Canadian pharmaceutical supply chains and warranting close monitoring by quality and trade teams.

3 May 2026, 09:10data.consilium.europa.euEuropean UnionCanada

Council of the EU Revises April 2026 Environment Work Programme

The Council of the EU has published a revised environment work programme for April 2026, scheduling working party discussions on CO2 standards for cars and vans, a new ECHA basic regulation, the BBNJ Directive, and key international conventions on air pollution, environmental impact assessment, public participation, hazardous waste, and climate change. This timetable signals when EU negotiators will shape positions on major climate, chemicals, and biodiversity files, helping compliance teams anticipate forthcoming policy shifts and plan engagement around these international and EU legislative processes.

30 Apr 2026, 06:23data.consilium.europa.euEuropean Union

Brazil Consultation on Mercosur Technical Regulation for Quantitative Indication of Cosmetics (G/TBT/N/BRA/1630)

Brazil has launched a WTO-notified national consultation on a Mercosur technical regulation that would harmonise quantitative labelling requirements for cosmetics, with comments open until 23 June 2026. If adopted, cosmetic manufacturers and importers selling into Mercosur, starting with Brazil, will need to review packaging formats and net content declarations to comply with the new metrological rules.

30 Apr 2026, 06:16docs.wto.orgBrazilMERCOSUR

UK Parliament Q&A: DEFRA Confirms Pesticides In Scope Of Proposed UK–EU SPS Agreement

DEFRA has told Parliament that pesticides regulations are part of the UK–EU sanitary and phytosanitary (SPS) alignment negotiations, in response to a question about crop protection products approved in Great Britain but not in the EU. This signals that GB-only crop protection products may be revisited under a future SPS agreement, so agrochemical manufacturers and growers should monitor the UK–EU talks for potential changes to product authorisations and market access, even though no specific products or timelines have yet been set.

28 Apr 2026, 19:54qna.files.parliament.ukUnited KingdomEuropean Union

EU Parliament Resolution on EU–UK Trade and Cooperation Agreement Highlights REACH Revision and PFAS Coordination

In November 2025 the European Parliament adopted, and in April 2026 the EU published, a resolution on implementing the EU–UK Trade and Cooperation Agreement that explicitly calls out chemicals regulatory divergence and PFAS thresholds between the EU and the UK. The resolution increases political pressure for closer EU–UK cooperation on the coming REACH revision and on PFAS limits in food and feed, signalling possible future regulatory convergence that chemical and food businesses trading across the Channel should anticipate in their compliance planning.

28 Apr 2026, 19:51eur-lex.europa.euEuropean UnionUnited Kingdom

EU Council Prepares CETA Joint Committee Position on Including Active Pharmaceutical Ingredients in GMP Mutual Recognition Annex

In April 2026 the EU Council circulated a decision text defining the Union’s position in the CETA Joint Committee on whether active pharmaceutical ingredients should be added to the EU–Canada GMP mutual recognition annex. If the Joint Committee ultimately agrees, EU and Canadian API manufacturers could see expanded mutual recognition of inspections, reshaping compliance planning and trade flows between the two markets.

28 Apr 2026, 18:20eur-lex.europa.euEuropean UnionCanada

EU Council Prepares CETA Joint Committee Decision to Add Active Pharmaceutical Ingredients to Mutual Recognition Annex

The EU Council is preparing to adopt the Union’s position in the CETA Joint Committee so that active pharmaceutical ingredients can be added to the mutual recognition annex for GMP compliance programmes with Canada. This will pave the way for APIs to benefit from streamlined EU–Canada GMP oversight, likely reducing duplicate inspections and easing cross-border manufacturing and supply for pharmaceutical producers once the joint decision is adopted.

28 Apr 2026, 18:12data.consilium.europa.euEuropean UnionCanada

Basel Convention OEWG Highlights 2028 HS Amendments for Selected Hazardous Wastes

The Basel Convention secretariat has reported that World Customs Organization amendments to Harmonized System codes for key Basel waste streams (plastic waste, PCB‑contaminated oils, and waste tyres) have been accepted and will enter into force on 1 January 2028, alongside ongoing work on plastic waste explanatory notes and new proposals for selenium- and tellurium-containing residues. This signals upcoming changes to customs classification for hazardous wastes and an opportunity, ahead of the July 2026 input deadline, for companies and authorities to influence which additional Basel waste types are reflected in HS codes and to prepare systems for Basel–customs data alignment.

24 Apr 2026, 09:24docs.un.orgGlobal

ECHA Updates OECD eChemPortal With Latest REACH Registration Data

ECHA has updated the OECD eChemPortal so that its ECHA CHEM REACH registration data, including around 5 000 updated registrations and 1 229 new substances, is now directly accessible and linked back to underlying dossiers as of 20 April 2026. This does not alter legal obligations but makes REACH data more visible and reusable across jurisdictions, strengthening global hazard screening and portfolio review workflows that depend on eChemPortal.

24 Apr 2026, 08:58echa.europa.euEuropean Union