International Conference on Harmonization of Technical Requirements for

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

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). 

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. 

The International Conference on Harmonization of Technical Requirements for the Registration for Pharmaceuticals for Human Use is a tripartite initiative by the EU, Japan, and the United States to harmonize the regulatory guidelines in these three regions in order to reduce duplication and redundancy in the development and registration of new drugs. 

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