Spring Intro 2023

24/03/2023

Sources of Guidance (2/3)

EudraLex – Volume 10 Clinical trials guidelines

Regulation EU No 536/2014 (once it becomes applicable) • Chapter I - Application and application documents • Chapter II - Safety reporting • Chapter III – Quality • Chapter V - Additional documents o Q&A Document o http://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/regulation5362014_qa_en.pdf

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Sources of Guidance (3/3)

Non-Clinical • ICH Topic M3 (R2): Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals • ICH guideline S6 (R1) – preclinical safety evaluation of biotechnology-derived pharmaceuticals • ICH Topic S9: Nonclinical Evaluation for Anticancer Pharmaceuticals Clinical • Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (‘CT-3’) • The EMA’s Paediatric Committee (PDCO) • Guide to the Quality and Safety of Tissues and Cells for Human Application Quality • QWP Guideline on the Requirements to the Chemical and Pharmaceutical Quality Documentation concerning IMPs in Clinical Trials • BWP Guideline on the Requirements for Quality Documentation Concerning Biological IMPs in Clinical Trials • GMP guidelines for IMPs – Annex 13

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