S9 Nonclinical Evaluation for Anticancer Pharmaceuticals
The ICH Harmonised Guideline was adopted under Step 4 in October 2009. This Guideline provides information for pharmaceuticals that are intended to treat cancer in patients with late stage or advanced disease regardless of the route of administration, including both small molecule and biotechnology-derived pharmaceuticals. It describes the type and timing of nonclinical studies in relation to the development of anticancer pharmaceuticals and references other guidance as appropriate.
Date of Step 4: 18 November 2009
Status: Step 5
Guidelines (Click the links below for complete guidelines)
Endorsed Documents (Click the links below for complete guidelines)
WG Presentations / Trainings (Click the links below for complete guidelines)
S9 Q&As Questions and Answers Nonclinical Evaluation for Anticancer Pharmaceuticals
The document was adopted under Step 4 in June 2018. Since reaching Step 4 and publication within the ICH regions, experiences by all parties with the implementation of the S9 Guideline on nonclinical evaluation for anticancer pharmaceuticals have resulted in the need for some clarification. The Questions and Answers developed by the S9 Implementation Working Group (IWG) are intended to facilitate the implementation of the S9 Guideline clarifying its scope as well as its interpretation and implementation.
Date of Step 4: 27 April 2018
Status: Step 5
Questions and Answers (Click the links below for complete guidelines)
Endorsed Document (Click the links below for complete guidelines)
WG Presentations / Trainings (Click the links below for complete guidelines)
*These Guidelines Belongs to ICH website.
