Harmonization of Testing Methods for Multicountry Submission

The ICH is a unique project that brings together the aforementioned regulatory agencies as well as experts from the pharmaceutical industry to discuss scientific and technical aspects of product registration. Its purpose is 

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Before the ICH, each country had its own testing requirements, with some health authorities requiring more testing and clinical trials than others. From a quality control standpoint, this would mean that the same product could require more testing depending upon where it was going to be distributed. 

A good example to illustrate this problem is carbamazepine. If we just consider the identification testing, depending on which pharmacopeia governs, up to four identification tests may be required. All together, there are six different identification tests among the pharmacopeias. An outline of the tests is presented in Table 2. 

Each pharmacopeia has at least one identification test, with Japan having the most at five. The goal of the ICH is to eliminate these differences and harmonize testing so that there would be one set of agreed-upon tests, with the optimal and most efficient tests included. 

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