Module 5 Presentations

05/07/2024

CTR: In more details

Note: Part I process aligned with VHP process

Part 1 (scientific): No local country process Part 2 (ethical): Review by national ECs remains Part 1 and 2 can be parallel or sequential

PART II (Ethic) modification 49-95 days (Art. 16-22) [max 145 days for ATMPs*] Addition of a new country 52-83 days (Art. 14) Tacit approval system once timelines have passed *ATMP -Advanced Therapy Medicinal Product Initial approval 60-106 days (Art. 5-8) [max 156 days for ATMPs*] 12 days for query response Substantial

PART II Submission (via Clinical Trial Info System ) PART I

FR

DE

ES

1 Reporting MS only

PT

etc.

- Validation - Asessment

- Validation - Assessment

Part I Evaluation Report

MS opinion

MS opinion MS opinion

…

Single MS decision

Single MS decision

Single MS decision

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

17

CTIS Structured data to replace «Application Form»

CTD •

CTR •

EudraCTapplication form completed by applicant for RA/EC per country via EudraCT website (download of xml and pdf for submission) • information then uploaded by each MS to feed into EudraCT database. Xml and pdf file included in each CTA • EudraCT feeds EU CT register =>Some fields are made public (consider internal review process for intellectual property)

Structured data, corresponding translation and all documents completed in the database and is submitted as the application. • All information provided in the Portal will be made public except if personal data or commercially confidential information (Quality information, financial arrangements with investigators) • Deferrals to apply for certain information

CTD: The applicant’s signature (in Section I) will confirm that • the information provided is complete, • the attached documents contain an accurate account of the information available, • the clinical trial will be conducted in accordance with the protocol, and • the clinical trial will be conducted, and SUSARs and result-related information will be reported, in accordance with the applicable legislation

Similar principle with CTD (confirmation statement to check before any submission)

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

18