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ICH guideline M3(R2) on non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals

ICH guideline M3(R2) on non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals

December 2009

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ICH guideline M3(R2) on non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals

December 2009
In this Technical Brief:
Product Type(s):

  • Pharmaceuticals
Topic(s):

  • Human Clinical Trials
  • Marketing Authorization
  • Regulatory Issues
Region(s):

  • United States

Full Info:


Resource Type:

Guidance Document

Citation:

European Medicines Agency (2013)

Authors:

European Medicines Agency

Product type(s):

  • ARVs
  • Hormonal
  • Microbicide
  • MPTs

Topic(s):

  • MPTs
  • Development
  • Regulatory

Region(s)

  • United States

URL of resource:

https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-m3r2-non-clinical-safety-studies-conduct-human-clinical-trials-marketing-authorisation_en.pdf

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