Module 9 2024

03/09/2024

New Clinical Trial Regulation (CTR)

Eu-CTD

EU-CTR

Multiple separate submission to each National competent Authority (NCA)

Single submission with a single approval with Reference Member State (RMS)

Procedural and approval time vary across countries

Fixed timelines for approval

Submission communication methods country specific

Single communication method via CTIS

Parallel addition Trial sites and countries during review

On-going review prevents further applications

Single CTA covering both Country specific and general (Quality) information

Two parts dossier

Part 1 (RMS)

Part 2 (CMS)

Cover letter and EU Application form

Participant leaflet and consent form

Protocol IB and IMPD

Suitability of investigators (CV) and of clinical stie

GMP compliance for the IMP

Proof of insurance

Financial arrangements and compensation for trail participants

SA and PIP

Proof of compliance for data processing and data protection assessment

The Organisation for Professionals in Regulatory Affairs

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EU-CTR: Procedural Outlook

Achieving consensus across all Member States and Competent Authorities for Part 1 Integrated Competent Authorities and EC for joint assessment of part 1 Agency/ Health Ministry relationships in some Member States Tight timeless for preparation of Sponsor response document and assessment

Environmental risk assessment evaluation

The Organisation for Professionals in Regulatory Affairs

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