International Conference Requirements

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... 

International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use... 

ICH Expert Working Group, Q1A Stability Testing of New Drug Substances and Products, International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use, 1994. 

In recent years, regulatory authorities and industry associations have undertaken several important initiatives to promote international harmonization of regulatory requirements. These efforts are designed to enhance harmonization and are committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. These efforts are undertaken under the auspices of the International Conference on Harmonization (ICH), which is organized to provide an opportunity for tripartite... 

International Conference on Harmonization, Validation of analytical procedures methodology, step 2. The Third International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Yokohama, Japan. Nov. 29-Dec. 1, (1995). 

International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use, [Internet]. URL http //www.ifp-ma.org/ichl.html, accessed 7-15-2000. 

Gutowski, T., Dahmus, J., and Thiriez, A., 2006. Electrical energy requirements for a manufacturing process, Proceedings of CIRP International Conference on Life Cycle Engineering 2006, Leuven, Belgium, pp. 623-628. 

EU (2001) EU directive 2001/83/EC. http //eur-lex.europa.eu/LexUriServ/site/en/consleg/2001/L/ 02001L0083-20070126-en.pdf. Cited 30 Dec 2008 EMEA (2008) European Medicines Agency. EPARs for authorised medicinal products for human use. http //www.emea.europa.eu/htms/human/epar/a.htm. Cited 30 Dec 2008 ICH (2008) The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). http //www.ich.org. Cited 30 Dec 2008 ISMP (2005) The Institute for Safe Medication Practices. List of confused drug names. http //www.ismp.org/Tools/confuseddrugnames.pdf. Cited 30 Dec 2008... 

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. 

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