ICH guidelines

The European Medicines Agency publishes scientific guidelines on human medicines that are harmonised by the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
Regulatory and procedural guidance

Slovenian is available via eTranslation, the European Commission's machine translation service.

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ICH guidelines are provided for: 

  • Quality
  • Safety
  • Efficacy
  • Multidisciplinary
  • Considerations
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