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be adopted into the national guidelines of Japan as well as of the United States and EU. |
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In general concept, no major differences in GCP guidelines exist between Japan, the United States, and EU; in 1995, at the Third ICH, comprehensive, harmonized GCP guidelines are expected to be released for discussion. |
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In October 1993 the Koseisho issued a discussion document promoting the development of a Summary Basis of Approval (SBA) Document for new drugs and thus showed a willingness to improve transparency of the approval basis for new drugs by CPAC in Japan. From March 30, 1994, SBAs will be developed for innovative Japanese products and orphan drugs. It is likely that the practice will spread to cover all newly registered products, including those of foreign origin. Additionally, it brings Japan into harmony with such transparency activities in the EU and the United States. |
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The Koseisho has become much more receptive to the inclusion within the Japanese physician's package circular of safety information derived from foreign data. Overall there is now little difference in this Japanese document from that in the other countries, with the exception of format and the quoting of local clinical study results. Entry Guidelines for Precautions for Use of Ethical Drugs [32] were updated in 1994 [33] in response to serious hemopoietic adverse reactions that resulted from an interaction between the antiviral agent sorivudine and fluorouracil type agents. The object of the guidelines was to increase the awareness among health professionals of drug interactions and adverse reactions. To this end, the section on drug interactions must be placed directly before the adverse-reactions section. Additionally, where the interaction has caused a serious and irreversible event or resulted in a fatality, its importance must be stressed by additionally entering it in the warning, general precautions, or contraindications section, as appropriate. Such entries must also be clearly placed on the covers of ethical drug physician's circulars of all new drug approvals. A two-year period was given for updating other circulars. As a result, the amount of safety information, including the listed adverse drug reactions (ADRs), has considerably increased in Japanese circulars. During development of a new compound that Koseisho has become more interested in being kept appraised of the status of foreign programs with particular reference to safety. |
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Significant changes have occurred in adverse-reaction reporting in Japan as it moves to position itself with those who have the most developed surveillance. Investigational adverse drug reactions are reported to the NDD of the PAB, while those occurring with marketed drugs are processed by the Safety Division. |
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