Module 5 Presentations

05/07/2024

Definitions (3) Reference Safety Information (RSI): CT-3, Section 7.2.3.2: The expectedness of an adverse reaction is determined by the sponsor in the reference safety information (‘RSI’). The RSI is contained in the Summary of product characteristics (‘SmPC’) or the Investigator Brochure (IB). For the UK: for detailed guidance about the RSI please refer to the Clinical Trials Facilitation Group (CTFG) Q&A document: 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

For the EU updated guidance is here: 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

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RSI-Updated guidance in the UK

• The UK will still accept the provisions in the CT1 and CT3 guidance insofar as they relate to the UK as a sovereign regulator • To use an RSI for a trial occurring in the UK: the RSI must be approved by the MHRA. If the trial is ongoing in the UK plus European Member States: RSI/IB implementation date is the date when the RSI/IB is approved by all member states and the UK. • Better to submit to the UK and EU Member States at the same time: efficiency! • For clarification about the RSI please refer to the MHRA Inspectorate blog: https://mhrainspectorate.blog.gov.uk/2021/02/05/reference-safety information-rsi-for-clinical-trials-part-iii/

The Organisation for Professionals in Regulatory Affairs

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