Spring Intro 2023

16/02/2023

Implementation: 3 Year Transition Period

Before Go-Live

Year 1

Year 2-3

> 3 Years

Jan 2025 onwards All CTAs in EU MSs are governed by the CTR regardless of submission date

Until Jan 2022 CTAs submitted and governed by the Directive 2001/20/EC

Jan 2022- Jan 2023 Option to submit under the Directive 2001/20/EC or the Clinical Trial Regulation 536/2014 (CTR)

Jan 2023 – Jan 2025 All new initial CTAs must be governed by the CTR Any ongoing trial can continue under the Directive 2001/20/EC, however, will need to be transitioned into CTIS if it continues beyond 2025

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Submission of CTA

Submission to Agencies, Questions & Approval

Compilation, Publishing, Review

Strategic Planning & Submission Document Development

● Who is the Sponsor? Applicant? Do you need an EU legal representative? ● National submissions (RA and EC) vs EU-CTR ● Timelines for Qs? Process for RTQs? What is your role in RTQs? Author / reviewer / co-ordinate / liaise with Agency to obtain clarification? ● How is RA communication archived? How are Agency commitments captured? ● Ensure GCP compliance and BE INSPECTION READY!!!

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