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EU Clinical Trials & Advanced Therapies Regulations, CTR 536/2014 & ATMP Standards

Track Clinical Trials Regulation (EU) No 536/2014 execution, CTIS single-portal authorizations, Advanced Therapy Medicinal Product (ATMP) approvals, and GMO clinical trial derogations.

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Clinical Trials, Biotech & ATMPs Regulatory Landscape & Compliance Overview

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

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

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Key Focus Areas: clinical trials regulation ctr 536 2014 clinical trials information system ctis advanced therapy medicinal products atmp gmo deliberate release medicinal clinical gene therapy cell therapy eu regulation paediatric investigation plans pip ema

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Official Clinical Trials, Biotech & ATMPs Gazettes & Notifications

Commission Delegated Regulation (EU) 2026/1470 of 2 July 2026 amending Delegated Regulation (EU) 2022/2202 by updating the list of selected cross-border projects in the field of renewable energy
European Commission · Fri, 11 Sep 2026 00:00:00 GMT · Not Applicable · Union Government
Renewable Energy And Clean Tech Energy Climate And Environment
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Commission Delegated Regulation (EU) 2026/1423 of 30 June 2026 amending Regulation (EU) 2019/1021 of the European Parliament and of the Council as regards chlorpyrifos
European Commission · Thu, 10 Sep 2026 00:00:00 GMT · Not Applicable · Union Government
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Commission Implementing Decision (EU) 2026/1978 of 8 September 2026 setting up the European Digital Infrastructure Consortium for Agri-Food (EDIC for Agri-Food)
European Commission · Wed, 09 Sep 2026 00:00:00 GMT · Not Applicable · Union Government
Digital Infrastructure Telecoms Semiconductors Technology Digital And Telecom Transport Infrastructure And Mobility Agriculture Food And Fisheries
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Commission Implementing Regulation (EU) 2026/2017 of 2 September 2026 on the registration of the geographical indication Brânză frământată de Teaca (PGI) in the Union register of geographical indications pursuant to Regulation (EU) 2024/1143 of the European Parliament and of the Council
European Commission · Wed, 09 Sep 2026 00:00:00 GMT · Not Applicable · Union Government
Food Safety Labelling And Gis Agriculture Food And Fisheries
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Commission Delegated Regulation (EU) 2026/1092 of 21 May 2026 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards for the establishment of an EU code of conduct for issuer-sponsored research
European Commission · Fri, 04 Sep 2026 00:00:00 GMT · Not Applicable · Union Government
Research Framework And Horizon Europe Education Research And Innovation
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Commission Implementing Regulation (EU) 2026/1166 of 28 May 2026 laying down implementing technical standards with regard to the mapping of the business indicator components with corresponding supervisory reporting references
European Commission · Thu, 03 Sep 2026 00:00:00 GMT · Not Applicable · Union Government
Banking And Prudential Regulation Financial Services Capital Markets
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Commission Delegated Regulation (EU) 2026/1214 of 9 June 2026 amending Regulation (EU) 2024/1257 of the European Parliament and of the Council as regards conditions for testing compliance with brake particle emission limits
European Commission · Thu, 03 Sep 2026 00:00:00 GMT · Not Applicable · Union Government
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Commission Delegated Regulation (EU) 2026/1167 of 28 May 2026 supplementing Regulation (EU) No 575/2013 of the European Parliament and of the Council with regard to regulatory technical standards specifying operational risk requirements
European Commission · Thu, 03 Sep 2026 00:00:00 GMT · Not Applicable · Union Government
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Commission Implementing Decision (EU) 2026/1973 of 1 September 2026 concerning certain interim emergency measures relating to African swine fever in Italy (notified under document C(2026) 6204)
European Commission · Wed, 02 Sep 2026 00:00:00 GMT · Not Applicable · Union Government
Animal And Plant Health Agriculture Food And Fisheries
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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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Frequently Asked Questions on Clinical Trials, Biotech & ATMPs Regulations

How does the Clinical Trials Regulation (CTR 536/2014) streamline clinical studies?

The CTR replaced national trial authorisations with a single harmonised application submitted via the Clinical Trials Information System (CTIS) portal, accompanied by a coordinated assessment across all reporting and concerned Member States.

How does the GMO Deliberate Release Directive interact with gene therapy clinical trials?

Directive 2001/18/EC requires an environmental risk assessment for any deliberate release of GMOs, including gene therapy vectors used in clinical trials. The Clinical Trials Regulation provides for simplified, coordinated GMO assessments for investigational medicinal products containing or consisting of GMOs, reducing duplication between national GMO authorities and clinical trial assessors.

What is the regulatory pathway for Advanced Therapy Medicinal Products (ATMPs) in the EU?

ATMPs (gene therapies, somatic cell therapies, tissue-engineered products, and combined ATMPs) require mandatory centralised marketing authorisation through the EMA, with scientific evaluation by the Committee for Advanced Therapies (CAT). Manufacturers must hold GMP certification, and the hospital exemption allows non-routine ATMPs to be prepared on a non-industrial basis under national rules.

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