ICH
The ICH guidelines are submitted to the Committee for Proprietary Medicinal Produc (CPMP) for endorsement once they have reached Step 2 or Step 4 of the
Guidance for Industry
http://www.fda.gov/cber/guidelines.htm The objective of this ICH GCP guidance is to provide a unified standard for the Epean Union
CBER ICH Guidances
International Conference on Harmonisation (ICH): Final Guideline on Quality of Biotechnical Produc: ysis of the Expression Construct in Cells Used for
E 6 (R1) Guideline for Good Clinical Practice
The objective of this ICH GCP Guideline is to provide a unified standard for (investigational) product (see the ICH Guideline for Clinical Safety Data
ICH Guidelines—Implementation of the 3Rs (Refinement, Reduction, and
ICH intended to prepare harmonized guidelines/guidances,. or internationally accepted common tions of ICH guidelines have been made. The time needed

CBER - ICH Guidances
International Conference on Harmonisation (ICH): Final Guideline on Quality of Biotechnical Products: Analysis of the Expression Construct in Cells Used for
ICH Guidelines—Implementation of the 3Rs (Refinement, Reduction, and
ICH intended to prepare harmonized guidelines/guidances,. or internationally accepted common tions of ICH guidelines have been made. The time needed
ich good clinical practice guidelines

IND Protocol Guidelines
(AR 40-7 App C-4; 21 CFR 312.23; ICH Guidelines for GCP 6.2.4) (AR 40-7 4-10a; 21 CFR 312.61; 21 CFR 312.59 ICH Guidelines for GCP 6.4.7)
ICH H T G G G C P
The objective of this ICH GCP Guideline is to provide a unified standard for (see the ICH Guideline for Clinical Safety Data Management: Definitions and
Regulations and Guidelines ICH
The tripartite harmonised ICH guideline was finalised (Step 4) in November 1996. 12NOV03, The Guideline was finalised, under Step 4 of the ICH process,
Industry perspectives on ICH guidelines.
In 1990 the International Conference on Harmonization (ICH) effort was begun with the intent of stan
Regsource Clinical, IRB, GCP Regulatory Page
FDA Guideline for Monitoring of Clinical Investigations, Society of Quality Assurance. INTERNATIONAL CONFERENCE ON HARMONIZATION (ICH)