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Ema Pms Info Day 2024

EVENT | PMS Info-day

Specially aimed at representatives from human trade organizations and national competent authorities

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Ema Ich Q14

NEWS | ICH Q14 Guideline on analytical procedure development

This guideline describes science and risk-based approaches for developing and maintaining analytical procedures suitable for the evaluation of the quality of drug substances and drug products. It complements ICH Q2 Validation of Analytical Procedures.

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Ema Qas Cep Maa Mav 2024

NEWS | QWP Questions and Answers: how to use a CEP in the context of a Marketing Authorisation Application (MAA) or a Marketing Authorisation Variation (MAV)

This document aims to clarify existing guidance as a compilation of required data to be submitted in a MAA or in certain MAVs when a CEP is referred to in the MA dossier. It is also applicable when an excipient covered by a CEP is used as an active substance (AS). Even if several aspects of this document would equally apply to ASMFs and when full information on active substance is provided in the MA dossier, the focus of this Q&A is on CEPs.

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