Spring Intro 2023

16/02/2023

EU Clinical trial Regulation 536/2014 (EU-CTR)

Part 1 (Scientific/Regulatory): Core study documents only - No local country process Part 2 (Ethical): Review by national ECs remains Part 1 and 2 can be parallel or sequential

Initial approval 60-106 days (Art. 5-8) 12 days for query response Substantial modification 49-95 days (Art. 16-22) Addition of a new country 52-83 days (Art. 14) Tacit approval system once timelines have passed

Submission (via Clinical Trial Information System CTIS)

PART I

PART II

1 RMS coordinates the review

FR

DE

AT

- Validation - Assessment

ES

etc

- Validation - Assessment

Part I Evaluation Report

MS Assess. opinion

MS Assess. opinion

MS Assess. opinion

Single MS decision

Single MS decision

Single MS decision

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EU-CTR: Clear assessment process and timelines

RMS agreement within 3-6 days

Dossier (Part I & II) Submission to EU Portal

If questions, 10 days response time and 5 days for reporting Member State (MS) feedback

Submission validation within 10 days

Validation

10 < 25 days

Part 1 draft assessment report sent to sponsor

If there are requests for further info sponsor must respond within 12 days

Draft assessment report distributed to all MS to review. All comments back within 12 days.

Within 26 days RMS drafts initial assessment report

MS have 12 days to review responses and RMS has 7 days to consolidate final report

Comments consolidated by RMS within 7 days

Part 1 Assessment 45 to 76 days*

*Assessment phase may be extended by 50 days for ATMPs

Conditions to be addressed by MS

Acceptable with conditions

Final assessment report to sponsor and MS. Possible that MS can disagree with RMS if justifiable and opt out

Trial can start if Part 2/ EC approved

Acceptable

5 days**

Outcome

Not Acceptable

Trial cannot be conducted

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