With the globalization of the pharmaceutical industry, efforts have been underway since 1990 to standardize drug applications in terms of content and format such that an application can be registered in different countries without being subjected to different registration requirements among countries. Via efforts that include the participation of the European Union, Japan, and the United States, ICH guidelines have been prepared or are in the process of being finalized on the topics of Quality (the Q series of guidelines), Safety (the S series of guidelines), Efficacy (the E series of guidelines), and Multidisciplinary (the M series of guidelines). Care has been taken while reaching consensus with the other world bodies that the information that is needed is based on U.S. laws and CFR regulations plus similar considerations for the other world regulatory agencies. Relevant ICH guidelines [http://www.ifpma.org/ichl] as related to this chapter which are either completed or at advanced stages of completion (step 4) are covered.6
The order of presentation of these guidelines is based on their completion dates (earliest to latest) and not the sequence number given by the ICH (e.g., E3 followed by E4, etc.). The reason is that it appears that clinical pharmacology and biopharmaceutic concepts, and related recommendations, got introduced in the earliest guidelines in a broad and diffused sense and they subsequently got elaborated upon and covered in more detail in later guidelines.
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