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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

This guidance was published by the European Medicines Agency (EMA).

December 2009

Click to view Guidance Document

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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
click to view Guidance Document
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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