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1989年我部共收到经省级初审,正式上报我部的中药新药113个,其中申请生产45个,申请临床的68个(包括报备案的四、五类品种)。1989年卫生部召开了三次中药新药审评会,会上审评品种48个,经会议及书面审评,符合新药审评办法要求,已经批准99个,其中批准生产或试生产的53个(一、二类23个,三类15个,四、五类15个)。详见表1、2。 从一年来的情报资料及审评状况来看,中药新药的审批主要有以下特点和问题:
In 1989, our ministry received a total of 113 new medicines of traditional Chinese medicine formally reported to the Ministry of Medicine from the preliminary examination at the provincial level. Among them, 45 were applied for production and 68 were applied for clinical trials (including the four or five types of reported cases). In 1989, the Ministry of Health held three review meetings of new drugs for traditional Chinese medicines. At the meeting, 48 varieties were reviewed and evaluated. After meeting and written review, they met the requirements of the new drug review methods and approved 99 of them, of which 53 were approved for production or trial production One, two 23, three 15, four, five 15). See Table 1 for details. Judging from the status of intelligence information and review over the past year, the examination and approval of new Chinese medicines mainly include the following features and problems: