CRED Getting the CMC Dossier Right 2024

28/08/2024

Regulations and Guidelines

Summary of Requirements for Active Substances in the Quality Part of the Dossier (CHMP/QWP/297/97) Feb 2005 ● New active drug substances ● Existing active drug substances – Pharmacopoeial – Non-pharmacopoeial

Guideline on the chemistry of active substances • EMA/454576/2016

The Organisation for Professionals in Regulatory Affairs

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Regulations and Guidelines

Directive 2003/63/EC (amending Dir 2001/83/EC) ● Module 3 requirements

Directive 2009/120/EC (more requirements on Mod 3) ● Advanced therapies – Gene therapy – Somatic cell therapy Directive 2004/24/EC (amending 2001/83/EC) ● Herbal medicinal products – Definition – Simplified registration procedure

The Organisation for Professionals in Regulatory Affairs

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