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The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality - M4Q(R1)

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Category

Document

Published on

Abstract

Guideline aims to harminze the approach to the eCTD to create efficiencies for reviewers and decrease the rejection rate for drug applications.

Journal

ICH M4

Type of publication

Document

Affiliations

  • International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

Article Classification

Guideline

Classification Areas

  • Regulatory

Tags

  1. CTD Section: Drug Product
  2. CTD Section: Drug Substance
  3. CTD Section: Quality Overall Summary
  4. Drug Product (ICH Q6 Context)
  5. Drug Substance (ICH Q6 Context)
  6. Guideline
  7. regulatory