Module 5 Presentations

05/07/2024

Development Safety Update Report (DSUR)/Annual Safety report

For the UK : Statutory Instrument 2004 N. 1031 35: Annual list of suspected serious adverse reactions and safety report For the EU: CTR Annex III (3)

More details: see International Conference of Harmonisation (ICH) HARMONISED TRIPARTITE GUIDELINE DEVELOPMENT SAFETY UPDATE REPORT E2F

The RSI in effect at the start of the reporting period serves as RSI during the reporting period.

For the UK: RSI that was approved at the beginning of the reporting period by both the MHRA and European Member States!!! For the EU: RSI approved in EU Member State

The DSUR should be used to support RSI changes.

The Organisation for Professionals in Regulatory Affairs

15

DSUR (2)

 The Sponsor must submit a DSUR on the safety of each Investigational Medicinal Product (IMP) used in a clinical trial for which it is the Sponsor (a single DSUR for all IMPs used in one CT may be possible).  The obligation starts with the first authorisation of a CT in accordance with current legislation [Development International Birth Date (DIBD); synchronisation with International Birth Date (IBD) is possible]. It ends with the end of the last CT conducted by the sponsor with the IMP.

For UK: DSUR guidance: Microsoft Word - DSUR-Guideline 08June2021.docx (publishing.service.gov.uk)

For the EU: CLINICAL TRIALS REGULATION (EU) NO 536/2014 https://health.ec.europa.eu/document/download/bd165522-8acf-433a-9ab1 d7dceae58112_en?filename=regulation5362014_qa_en_0.pdf

The Organisation for Professionals in Regulatory Affairs

16