Transcription of S6(R1) Step 5 Preclinical safety evaluation of ...
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S6(R1) Step 5 Preclinical safety evaluation of ...
7 Westferry Circus Canary Wharf London E14 4HB United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 75 23 70 40 E-mail Website An agency of the European Union European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged. June 2011 EMA/CHMP/ICH/731268/1998 Committee for medicinal products for human use (CHMP) ICH guideline S6 (R1) Preclinical safety evaluation of biotechnology-derived pharmaceuticals Step 5 Part I (Parent guideline) Transmission to CHMP November 1996 Release for consultation November 1996 Deadline for comments May 1997 Final approval by CHMP September 1997 Date for coming into operation March 1998 Part II (Addendum) Transmission to CHMP November 2009 Release for consultation November 2009 Deadline for comments February 2010 Final approval by CHMP July 2011 Date for coming into operation December 2011 Preclinical safety evaluation of biotechnology-derived pharmaceuticals Table of contents Part I.
Regulatory standards for biotechnology-derived pharmaceuticals have generally been comparable among the European Union, Japan and United States. All regions have adopted a flexible, case-by-case, science-based approach to preclinical safety evaluation needed to support clinical development and marketing authorisation.
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