ICH International Conference

ISO 10993-3 (1993) sets forth clear guidance on testing requirements as summarized in Table 6.1. ICH (International Conference on Harmonization) guidance, shown in Table 6.2, has different but also clear requirements. They want to see an in vivo test conducted. While FDA has no clear guidelines, it expects that an appropriate adaptation of one of these two be performed. 

Note GLP = Good Laboratory Practice ICH = International Conference on Harmonization IND = Investigational New Drug JMHW = Japanese Ministry of Health and Welfare MAA = Marketing Authorization Application NCE = New Chemical Entity. 

The USP definition of robustness is equal to that of the ICH (International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use), which is given below. 

Cone M, D Arcy PF and Harron DWG. ICH international conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. IntPhann J 1996 10 104-6. 

Recent initiatives by global organizations such as ISO (International Organization for Standardization, www.iso.org) and ICH (International Conference on Harmonization, www.ich.org) are attempting to bring consistency in concept and standardization in definition to the QMS. In 2004, the Pharmaceutical Inspection Co-Operation Scheme (PIC/S, www.picscheme.org) issued its recommendation on Quality System Requirements for Pharmaceutical Inspectorates. The U.S. Food and Drug Administration (FDA) initiated inspection surveillance approaches based upon QMS organization and is another source of definition and interpretation. 

Abbreviation. ICH, International Conference on Harmonisation. Source From Ref. 8. 

Hypoalgesia ICH (International Conference on Harmonization) Diminished sensitivity to a noxious stimulation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to harmonise scientific and technical aspects of product registration. They make recommendations which will be adopted by the national / EU authorities after an approval process. 

All the above-mentioned legal treatises apply to the European Economic Area (EEA this comprises the 27 EU member states plus Liechtenstein, Iceland, and Norway—Switzerland chose by referendum not to join the EEA, but has certain Swiss-EU bilateral agreements). Switzerland acts as the representative of the European Free Trade Association, which is an observer in the ICH (International Conference on Harmonization) process, accepts ICH guidelines, but is not part of the European Economic Area. There is a legal obligation for the Swiss competent authority, Swiss Agency for Therapeutic Products (Swissmedic), to take account of decisions/authorizations in other territories that have equivalent medicinal product control. 

Hsu, J. C. (1996). Multiple Comparisons Theory and Methods. Chapman Hall, London. Hsu, J. C., Chang, J. Y., and Wang, T. (2002). Simultaneous confidence intervals for differential gene expressions. Technical Report 592, The Ohio State University, Columbus. ICH E10 (1999). Choice of Control Groups in Clinical Trials. CPMP (Committee for Pro-pritary Medical Products), EMEA (The European Agency for the Evaluation of Medical Products), London, Draft ICH (International Conference on Harmonisation). Efficiency guidelines, http //www.ich.org. 

Following the ICH (International Conference on Harmonization of Technical Requirements of Pharmaceuticals for Human Use) definition, an impurity is every separate chemical particle present in the active substance and final pharmaceutical product that is not the active substance or excipient. This includes all optical isomers, products of degradation, and polymorphic forms. The physicochemical properties and biological activity of dmg impurities can be similar or different to those of the active substance. Therefore, they can influence the human body in the same way as the medicinal product or differently [7] and lead to an increase or decrease in dmg activity. 

ICH International Conference on Harmonization (drug regulatory requirement). 

Regulatory agencies are continuously pushing the quahty systems that appear in the early phases of drug development. The ICH (International Conference on Harmonization) offers several guidelines for the characterization of the drug substance. Notably, these include ... 

ICH (International Conference on Harmonization). Guidance for Industry. S8 Immunotoxicity Studies for Human Pharmaceuticals, 2006. 

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