[Our policy and future tasks related to ICH in anti-cancer drug development--a discussion from the viewpoint of an enterprise].

International harmonization of data to be submitted in order to receive governmental authorization for the release of new medicines (ICH) has been promoted by Japan, the USA and European countries. Because of this trend, the Japanese drug authority, the medical institutions which perform clinical trials of not yet authorized new drugs and the pharmaceutical companies which contract these trials to medical institutions, are now required to change greatly their conventional views concerning drug development. The trend towards ICH has also been having a great impact on the development of anti-cancer agents in Japan. The greatest impact of ICH is that it requires pharmaceutical companies to take responsibility for the planning, pursuit and management of clinical trials of new drugs. To meet this requirement, it is urgent that pharmaceutical companies educate and train staff members involved in drug development, so that they attain high levels of medical proficiency in the field concerned. It is also necessary for these companies to organize in house groups of specialists in making clinical trials, who can evaluate clinical data and make decisions about outcomes by themselves. At the same time, medical institutions are required to establish a system which supports the clinical trials carried out within the hospital, while meeting the appropriate guidelines. Thus, medical institutions are required to make greater efforts to ensure adequate disclosure of diagnosis of cancer to a patient, obtain informed consent from patients and develop a hospital system capable of conducting excellent clinical trials. The governmental authority related to drugs is required to improve drug administration, including streamlining regulations and providing consultation services concerning the appropriate strategy for particular clinical trials. If the relevant governmental authority, medical institutions, pharmaceutical companies and mass media cooperate with the goal of improving the environment and systems related to clinical trials, the current system of clinical trials will be improved significantly, allowing more scientific and ethical clinical trials. This, in turn, will promote the smoother development of anti cancer agents in this country. At present, both the views on and the manner of conducting clinical trials (especially phase I clinical trials) differ in Japan and Western countries. These differences cause differences in the scheduling of preclinical studies, possibly leading to delayed commencement of phase I clinical trials in Japan. Among these issues, the procedures for preclinical studies of safety and pharmacokinetics studies (absorption, distribution, metabolism and elimination of drugs) need to be internationally standardized as soon as possible.