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1997年4月日本GCP修正版正式实行造成了很多日本制药企业一度中断了新药的临床试验。如卫材公司从4月至6月就中断了3个月。因为GCP新规定要求在实施新药临床试验时,应向病人或健康志愿者进行充分的说明,并取得病人等的同意。同时规定,这是医生的义务。只有口头的说明和承诺是不够的,必须要有书面文件,才能进行临床试验。日本制药界为了维持发展,一直采用的手段是扩大销售以应付药价降低,开发新药
In April 1997, the official implementation of the GCP revision in Japan caused many Japanese pharmaceutical companies to suspend clinical trials of new drugs. For instance, Eisai Company was suspended for three months from April to June. Because the new GCP regulations require the implementation of new drug clinical trials, patients or health volunteers should be fully explained and obtained the consent of the patient. At the same time, this is the duty of the doctor. Only verbal instructions and commitments are not enough, there must be written documents to conduct clinical trials. In order to maintain development, the Japanese pharmaceutical industry has always used the means to expand sales to cope with lower drug prices and develop new drugs.