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What is Overview of ICH QSEM Guidelines about?

The ICH guidelines aim to harmonize pharmaceutical regulatory standards globally, focusing on Quality, Safety, Efficacy, and Multidisciplinary aspects (QSEM). The Q-series guidelines specifically address pharmaceutical quality assurance, particularly in stability testing, ensuring medicines remain safe and effective throughout their shelf life. The ICH harmonization process involves multi-step consensus building and regulatory consultation to enhance access to quality medicines worldwide.

Author

sujithapsk1708

Language

EN