International Conference drug products

International Conference on Harmonisation Draft Guidance on Specifications Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products Chemical Substances Notice, Fed Regist. Docket No. 97D-0448, 1997. 

HHS/FDA International Conference on Harmonisation Stability Testing of New Drug Substances and Products Guideline Availability Notice, Federal Register, September 22, 1994... 

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... 

International Conference on Harmonization. Guidance on Q6A specifications test procedures and acceptance criteria for new drug substances and new drug products chemical substances. Fed Reg 2000 65(251) 83,041-83,063. 

International Conference on Harmonization Q6A Guideline Specifications for new drug substances and products Chemical Substances, October 1999. 

Impurities in new drug products Q3B (R2), International Conference on Harmonisation, 2006, http //www.ich.org/cache/compo/276-254-l.html... 

International Conference of Harmonization Q3B (R), Impurities in New Drug Products (Revised Guideline), Federal Register 68,2003. 

Anon. Stabdity testing of new drugs and products. In International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceutical for Human Use, 2000. http //www.ifpma.org/ ich5q.html Stability. 

International Conference on Harmonisation (ICH) of Technical Requirements of Pharmaceuticals for Human Use. Topic E4 Note for Guidance on Dose-Response Information to Support Drug Registration, CPMPIICHI378I95. London European Agency for the Evaluation of Medicinal Products, 1994. 

In addition, the International Conference on Harmonization has issued a guidance document pertinent to pediatric drug development Ell, Clinical Investigation of Medicinal Products in the Pediatric Population (www.fda.gov/cder/guidance/index.htm). 

To facilitate worldwide registration and marketing of the drug product, more and more, drug research, development, and production are performed at multiple sites located in different countries. A tripartite organization, known as the International Conference on Flarmonization (ICFI), was established in 1991 to address the possibil-... 

International Conference on Harmonization (ICH) (2003), Guidance for industry, Q1A (R2) stability testing of new drug substances and products, ICH, Brussels, Belgium. 

Grimm W. (1998), Extension of International Conference on Harmonization tripartite guideline for stability testing of new drug substances and products to countries of climatic zones III and IV, Drug Dev. Ind. Pharm., 24,313-325. 

The U.S. Food and Drug Administration (FDA) defines novel (new) pharmaceutical excipients as those substances used in the United States for the first time in a human drug product or by a new route of administration (1). The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) includes sections in its Common Technical Document (CTD) that details the information required for the approval of novel (new) excipients. Information on the control of excipients is included in Section P.4 of the CTD, and any additional information that may be required should be included in Appendix A.3 of the CTD. 

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