Big Chemical Encyclopedia

Chemical substances, components, reactions, process design ...

Articles Figures Tables About

Registration technical 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... [Pg.36]

International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use... [Pg.142]

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. [Pg.173]

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). [Pg.718]

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. [Pg.790]

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... [Pg.110]

ICH (1996). 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. [Pg.230]

See other pages where Registration technical requirements is mentioned: [Pg.320]    [Pg.333]    [Pg.39]    [Pg.37]    [Pg.306]    [Pg.167]    [Pg.342]    [Pg.101]    [Pg.9]    [Pg.26]    [Pg.74]    [Pg.259]    [Pg.773]    [Pg.844]    [Pg.70]    [Pg.105]    [Pg.305]    [Pg.475]    [Pg.475]    [Pg.480]    [Pg.193]    [Pg.360]    [Pg.452]   


SEARCH



International Conference on Harmonization of Technical Requirements for Registration

International Conference on Harmonization of Technical Requirements for the Registration

Registration

Registration Requirements

Technical requirements

© 2024 chempedia.info