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Library

Concept Papers

  • VICH/20/041-Final: Concept Paper for the adoption of ICH Q7: Good Manufacturing Practice for active pharmaceuticals ingredients
  • VICH/20/061-Final: Concept Paper on the development of further guidance around medicated premixes
  • VICH/20/006-Fin: Concept Paper on Revisions of VICH Pharmacovigilance Guidelines (VICH GL24, VICH GL29)
  • VICH/20/005-Fin: Concept Paper for a Guideline on Test on the Presence of Extraneous Viruses in veterinary viral vaccines
  • VICH/20/004-Fin: Concept Paper for a Guideline for Safety Evaluation of Biotechnology-derived/Biological products
  • VICH/17/025-Final - VICH Concept Paper for a general guideline on pharmaceutical combination products
  • VICH/19/048-Final: Concept Paper to elaborate VICH guidelines on in vitro dissolution testing and biowaivers for in vivo blood BE determinations
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