International Conference on Harmonization of Technical Requirements for the Registration

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. 

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 Registration of Pharmaceuticals for Human Use... 

In November 1991, in Brussels, the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was held. A new topic was proposed to, and accepted by, the ICH Steering Committee. This was the thorny issue of tripartite mutual acceptance of foreign data. It was assigned the prefix E5 (efficacy, fifth topic approved) but was to be one of the slowest to be resolved - as the reader by now will appreciate, slowly resolved because of its complexity, not... 

In addition to those items previously mentioned, the FDA is also participating in the development and use of international standards to facilitate pharmaceutical development. The goals of the International Conference on Harmonization of Technical Requirement for Registration of Pharmaceuticals for Human Use (ICH) is to facilitate the mutual acceptance of data submitted in support of drug marketing applications by the European Union, Japan, and the United States. The ICH has developed a number of guidelines and standards to harmonize post-marketing surveillance efforts on an international level. 

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