Harmonisation, ICH

In November 1997, the Department of Health and Human Services along with the International Conference on Harmonisation (ICH) released a draft guidance for the selection of test procedures, which included chiral drugs. For the development of an enantiopure drug substance, acceptable criteria shall include, if possible, an enan-tioselective assay. This assay should be part of the specification for the identification of an enantiopure drug substance and related enantioenriched impurities [16]. 

The International Conference on Harmonisation (ICH) of technical requirements for the registration of pharmaceuticals for human use was established in 1990 as a joint regulatory/industry project to improve, through harmonisation, the efficiency... 

As vith human pharmaceuticals, all safety studies must be conducted in accordance vdth the principles of Good Laboratory Practice (GLP). Similar to the International Conference on Harmonisation (ICH), the Veterinary International Conference on Harmonisation (VICH) has developed agreed guidelines on the types of test and other considerations that need to be addressed during the development and evaluation of veterinary medicines. A list ofVICH guideline topics is provided in Table 7.1. 

International Conference on Harmonisation. ICH-S8, Immunotoxicity Studies for Human Pharmaceuticals, 2005. 

International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals. S2A document recommended for adoption at step 4 of the ICH process on July 19, 1995, Federal Register 61 18198-18202, April 24,1996. 

Study monitors or clinical research associates (CRAs) can be employed by the study sponsor, CRO, or independently contracted for a specific study and, according to the International Committee on Harmonisation (ICH) and formalized by FDA in the Guidance for Industry Good Clinical Practice (GCP), the purpose of a CRA is to ... 

Scales MDC. Implications of recommendations from the International Conference on Harmonisation (ICH) for the safety evaluation of new medicines involving animal studies for the pharmaceutical industry. Adverse Drug React Toxicol Rev 1992 11 5-12. 

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