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EU Healthcare, Pharmaceuticals & Life Sciences Regulations & EMA Decisions

Comprehensive intelligence on EU pharmaceutical package reforms, EMA marketing authorisations, MDR/IVDR compliance, European Health Data Space, and HERA crisis measures in the OJ L series.

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Healthcare, Pharmaceuticals & Life Sciences Regulatory Landscape & Compliance Overview

Official Intelligence

PolicyIndex indexes real-time gazette notifications, policy orders, tariff determinations, and compliance circulars issued across the Healthcare, Pharmaceuticals & Life Sciences sector. Regulatory intelligence is aggregated across central ministries, state regulatory commissions, and statutory authorities.

Statutory Directives

Official Extraordinary Gazettes, S.O. & G.S.R. orders, and executive notifications.

Compliance Mandates

Sector-specific regulatory obligations, licensing norms, and statutory filing guidelines.

Key Focus Areas: eu pharmaceutical legislation reform european medicines agency ema decisions medical devices regulation mdr european health union dg sante regulations cross border healthcare directive

Specialized Healthcare, Pharmaceuticals & Life Sciences Verticals

Medicines, Biologicals & Pharmacovigilance → Medical Devices & In Vitro Diagnostics → Public Health, Crisis Preparedness & HERA → Clinical Trials, Biotech & ATMPs →
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Official Healthcare, Pharmaceuticals & Life Sciences Gazettes & Notifications

Commission Delegated Regulation (EU) 2026/1405 of 26 June 2026 correcting certain language versions of Regulation (EU) 2021/821 of the European Parliament and of the Council setting up a Union regime for the control of exports, brokering, technical assistance, transit and transfer of dual-use items
European Commission · Tue, 01 Sep 2026 00:00:00 GMT · Not Applicable · Union Government
Defence Industry And Dual Use Manufacturing Trade And Industrial Policy
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Commission Delegated Regulation (EU) 2026/1310 of 11 June 2026 supplementing Regulation (EU) 2024/3110 of the European Parliament and of the Council by establishing the applicable assessment and verification systems for product families and categories
European Commission · Fri, 28 Aug 2026 00:00:00 GMT · Not Applicable · Union Government
Product Compliance And Ce Marking Manufacturing Trade And Industrial Policy
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UN Regulation No. 129 - Uniform provisions concerning the approval of Enhanced Child Restraint Systems used on board of motor vehicles [2026/1534]
European Commission · Fri, 28 Aug 2026 00:00:00 GMT · Not Applicable · Union Government
Product Safety Machinery Ce Marking Manufacturing Trade And Industrial Policy
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Decision No 1/2026 of the Specialised Committee on Participation in Union Programmes established by Article 8(1), point (s), of the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part, of 15 April 2026 amending Protocol I to the Trade and Cooperation Agreement [2026/1962]
European Commission · Thu, 27 Aug 2026 00:00:00 GMT · Not Applicable · Union Government
International Trade And Trade Defense Manufacturing Trade And Industrial Policy Energy Climate And Environment Law Enforcement And Judicial Cooperation
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Commission Delegated Regulation (EU) 2026/1281 of 12 June 2026 amending Regulation (EU) 2019/1154 of the European Parliament and of the Council on a multiannual recovery plan for Mediterranean swordfish
European Commission · Mon, 24 Aug 2026 00:00:00 GMT · Not Applicable · Union Government
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Commission Delegated Regulation (EU) 2026/1342 of 17 June 2026 amending Delegated Regulation (EU) 2015/98 on the implementation of the Union’s international obligations, as referred to in Article 15(2) of Regulation (EU) No 1380/2013 of the European Parliament and of the Council, under the International Convention for the Conservation of Atlantic Tunas and the Convention on Future Multilateral Cooperation in the Northwest Atlantic Fisheries
European Commission · Mon, 24 Aug 2026 00:00:00 GMT · Not Applicable · Union Government
Common Fisheries Policy And Aquaculture Agriculture Food And Fisheries
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Commission Delegated Regulation (EU) 2026/1304 of 12 June 2026 amending Delegated Regulation (EU) 2022/2292 as regards the requirements for the entry into the Union of certain dairy products, certain fishery products and bivalve molluscs, echinoderms, tunicates and marine gastropods
European Commission · Mon, 24 Aug 2026 00:00:00 GMT · Not Applicable · Union Government
Medicines And Pharmacovigilance Healthcare & Pharma
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Commission Delegated Regulation (EU) 2026/1282 of 12 June 2026 amending and correcting Annexes IV and V to Regulation (EU) 2019/1242 of the European Parliament and of the Council as regards the data to be monitored, reported and published
European Commission · Fri, 21 Aug 2026 00:00:00 GMT · Not Applicable · Union Government
Digital Infrastructure Telecoms Semiconductors Technology Digital And Telecom
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Commission Delegated Regulation (EU) 2026/971 of 4 May 2026 supplementing Directive 2004/109/EC of the European Parliament and of the Council with regard to regulatory technical standards on access to regulated information at Union level and repealing Commission Delegated Regulation (EU) 2016/1437
European Commission · Wed, 19 Aug 2026 00:00:00 GMT · Not Applicable · Union Government
Law Enforcement And Judicial Cooperation Justice Home Affairs And External Relations
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Commission Delegated Regulation (EU) 2026/1761 of 12 June 2026 amending Regulation (EU) 2018/975 of the European Parliament and of the Council as regards the time limits for the submission of the annual scientific report and total annual catch reporting, line weighting standards in Annex I, vessel data requirements in Annex V, observer data requirements in Annex X, and port data requirements in Annexes XI and XII
European Commission · Mon, 17 Aug 2026 00:00:00 GMT · Not Applicable · Union Government
Maritime Transport And Ports Transport Infrastructure And Mobility Digital Infrastructure Telecoms Semiconductors Data Protection And Cybersecurity
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Frequently Asked Questions on Healthcare, Pharmaceuticals & Life Sciences Regulations

Which EU bodies regulate pharmaceuticals and medical devices?

The European Commission (DG SANTE) proposes health legislation. The European Medicines Agency (EMA) evaluates human and veterinary medicinal products. Medical devices are evaluated by national designated Notified Bodies and coordinated through the Medical Device Coordination Group (MDCG).

What is the European Health Union and what legislation underpins it?

The European Health Union is a policy framework comprising the HERA authority for health emergency preparedness, Regulation (EU) 2022/2371 on serious cross-border health threats, strengthened mandates for the EMA and ECDC, the European Health Data Space (EHDS), and the proposed pharmaceutical legislation revision.

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