Guidelines ICH

• Q6A  : Chemical Substances
  Implementation (Step 5):
  EU: Adopted by CPMP, November 1999, issued as CPMP/ICH/367/96
  MHLW: Adopted May 1, 2001, PMSB/ELD, Notification No. 568
  FDA: Published in the Federal Register, December 29, 2000, Volume 65, Number 251, Notices, Page 83041-83063
• Q6B  : Biotechnological Substances
  Implementation (Step 5):
  EU: Adopted by CPMP, March 99, issued as CPMP/ICH/365/96
  MHLW: Adopted May 1, 2001, PMSB/ELD, Notification No. 571
  FDA: Published in the Federal Register, August 18, 1999: 64FR Page 44928

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Jean Cumps - Faculé de Médecine UCL - Ecole de Pharmacie - TPAO