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ICH

The International Committee for Harmonisation (ICH)

This page provides access to regulatory guidance and other resources that are generally available from web sites operated and maintained by other organizations.

These guidelines have been prepared through close co-operation between the European Union, Japan and the United States of America.

Note: These links take you directly to the documents on the ICH or other authorities' web site. Please contact us and let us know if you have problems accessing them.

Title		Type	Posted
	Q7A; Good Manufacturing Practices for Active Pharmaceutical Ingredients.*	Guidance for Industry	November 2000
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	Q6B; Specifications, Test and procedures for Biotechnological/Biological Products*	Note for Guidance	January 1999
	S2B Genotoxicity: A Standard Battery for Genotoxicity Testing of	Note for Guidance	July 1997
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	E8; General Considerations for the clinical Trials	Note for Guidance	July 1997
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	S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals	Note for Guidance	July 1997
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	Q5A(R1): Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin	Note for Guidance	March 1997
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	Q5D; Derivation and Characterization of Cell substrates Used for Production of Biotechnological/Biological Products*	Note for Guidance	January 1997
	E6 Guidelines for Good Clinical Practice	Note for Guidance	April 1996
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	Q5C; Quality of Biotechnological Products: Stability Testing of Biotechnology/Biological Products	Note for Guidance	November 1995
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	Q5B: Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products	Note for Guidance	November 1995
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