Module 5 Presentations

05/07/2024

Evolutions in legal bases and sources

CTD related

CTR related

Directive 2001/20/EC (CTAs) Directive 2005/28/EC (GCP) Directive 2003/94/EC (GMP)

Regulation (EU) No 536/2014 (CTAs)

Implementing Regulation (EU) 2017/556 (GCP) Directive 2017/1572 (GMP) Delegated Regulation (EU) 2017/1569 (GMP) GMP Commission guideline on IMPs Labelling requirements in CTR Annex VI Draft – EU COM Questions & Answers Document Reg. (EU) 536/2014 – Version 6.8 (March 2024) Eudralex Volume 10 guidelines (updates ongoing)

Volume 4 GMP Annex 13 (IMPs)

Draft – EU COM Questions & Answers Document - Version 11.0 (May 2013)

Eudralex Volume 10 guidelines

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

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Scope / Initial considerations

Topic

CTD

CTR

Change in Legal Basis

Directive Implemented in national laws

Regulation Directly applicable

Scope

Remains the same • Interventional clinical trials on medicines in humans • Non interventional studies are excluded • Member States are responsible for the review and approval of CTAs • Increased collaboration between MSs (as seen with VHP)

Transparency

Someinformation from EudraCT visible in EU CT register

Increased transparency: Data: Main characteristics of the clinical trial Documents: Protocol + synopsis, Patient docs Result portings + Laypersons summaries Articulation with Policy 70 CTIS (Sponsor / MS, EMA, EU COM / Public)

Results posting

IT system

EudraCT database (NCA- managed)

Sponsorship

One unique Sponsor

Co-sponsorship possible (CTR Art. 72)

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

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