Module 5 Presentations

05/07/2024

Reference Safety Information • RSI serves 3 purposes • Information of investigator • Basis for expectedness in SUSAR reporting • Basis for annual safety report

• Various processes for generating RSI exist among CT Sponsors • Various expectations have arisen from CAs through IB questions

No MA in the EU

Investigator’s Brochure (IB) Used within terms of MA: SmPC Used outside terms of MA: IB

IMP

MA in the EU

CTFG Q&A document on Reference safety information (Nov 2017) and Covering note (Mar 2018) • http://www.hma.eu/fileadmin/dateien/Human_Medicines/01 About_HMA/Working_Groups/CTFG/2017_11_CTFG_Question_and_Answer_on_Reference_Safety_Information_2017.pdf • https://www.hma.eu/fileadmin/dateien/Human_Medicines/01 About_HMA/Working_Groups/CTFG/2018_03_CTFG_RSI_Q_A_Covernote.pdf

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

23

CTR : Review and Assessment timelines

• Reference member state (RMS) • Proposed by Sponsor / Confirmation of RMS within 6 days • If no agreement between MS, proposed becomes RMS • Validation (parallel to RMS selection) • Validation to be provided within 10 days ( tacit validation if not) • If requests for information (RFI), deadline (fixed by RMS) up to 10 days • Notification of validation within 5 days of answers provided by Sponsor • Part I assessment • Initial assessment by RMS within 26 days • Coordinated review between RMS and CMS up to 12 days (additional) • Possibility to extend timelines by 50 days for IMPs under Point 1, Annex to Reg (EC) 726/2004 (broader than formal ATMPs only) • If RFIs, deadline (fixed by RMS) up to 12 days • Assessment of answers by RMS 12 days then coordinated assessment up to 7 days • Part II assessment •

Submission Options

Part I + Part II (preferred by MS)

Part I only (Art.11, 2 years to submit Parts II afterwards)

Assessment by CMS within 45 days • RFIs may be raised as needed during that period by each country • If RFIs, deadline (fixed by CMS) up to 12 days • Assessment of answers by CMS within 19 days • Reviewing answers cannot extend the review period by more than 31 days in total

• Decision within 5 days of the Part I reporting date or of the last day of Part II assessment completion, whichever is later

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

24