CRED 8 Presentations

01/07/2024

Module 1.9 Information relating to clinical trials

• Contains a statement that clinical trials have been performed and carried out according to Good Clinical Practice and meet the ethical requirements of Directive 2001/20/EC or Clinical Trial Regulation 536/2014 should be provided, where applicable. • The above statement should ‘indicate that “clinical trials carried out outside the European Union meet the ethical requirements of Directive 2001/20/EC” together with a listing of all trials (protocol number) and third countries involved.’ (Notice to Applicants) • A list of investigators and sites and subjects by country for each clinical trial described in the MAA should be included in this section. Note : a simpler table of studies with protocol numbers, study titles, and countries has been accepted.

The Organisation for Professionals in Regulatory Affairs

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Module 1.10 Information relating to paediatrics

Although applicable to MRP and DCP in practice PIPs are mainly submitted for CPs as relate to new chemical or new biological entities.

The following documents should be included in this section, as appropriate: • Copy of the product-specific waiver decision or class-waiver decision • Copy of the latest version of the PIP Decision(s) (incl. deferrals, if applicable), together with if available: - Copy of the PDCO opinion on PIP compliance + report. - If available, overview table of the PIP results. • Ensure all non-deferred PIP binding elements are completed and checked as part of compliance check prior to submission of MAA Note : Important to plan these activities in MAA submission timings as compliance check takes couple of months. Very detailed process including check against CSR for clinical binding elements / non-clinical reports etc.

The Organisation for Professionals in Regulatory Affairs

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