🇰🇷 Korea Drug Review Briefing session on Nitrosamines

Guidance, Documents, Resources
1

This is the Drug Review Briefing Session presentation material held on 10-Nov-2023. MSDF published these slides to help the pharmaceutical industry improve their understanding of drug review and develop safe and effective drugs.

It covered the following contents:

  1. Introduction of the New Standard for Nitrosamine Impurities for Global Regulatory Harmonization
  • Main causes and changes in the environment of nitrosamine occurrence
  • Method for setting impurity standards
  • New impurity standard setting method: CPCA

Google translation of presentation ppt

IDRAC_375151_12-Dec-2023_MFDS Presentation_ Pharmaceutical Products Drug Review Briefing Session in en.pdf (4.5 MB)

Original Korean document
IDRAC_375151_12-Dec-2023_MFDS Presentation_ Pharmaceutical Products Drug Review Briefing Session in .pdf (3.6 MB)

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