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日本国厚生省卫生福利部先后于1994年1月19日、4月1日、7月1日和10月5日发布了有关批准生产或同意进口新药的公告。公告共批准了40种新药,其中有以30种牌号供应的22种新药是先后在日本国开发的,而以28种牌号供应的18种新药属批准同意进口的新药。公告中述及的新药系指在主要组成方面与早先批准生产或进口的有所不同;在应用治疗药效方面,这次批准的新药进入市场销售后,尚需进行“市场销售监督”post-marketing surveillance(PMS)
The Ministry of Health and Welfare of Japan’s Ministry of Health and Welfare issued announcements on January 19, April 1, July 1 and October 5, 1994 approving the production or agreeing to import new drugs. The announcement approved a total of 40 new drugs, of which 22 new drugs supplied with 30 brands were successively developed in Japan, and 18 new drugs supplied under 28 brands were approved to import new drugs. The new drug referred to in the announcement refers to the main composition differing from the earlier approved production or import; in the application of therapeutic efficacy, after the new drug approved for sale enters the market, “market sales supervision” is still required. Post-marketing surveillance (PMS)