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药品作为一种特殊商品,“安全、有效、质量可控”是其基本要求。中药作为防病治病、康复保健的一种重要药品形式,开发新品应充分考虑药品社会性、科学性、合规性、经济性的发展要求。其中社会性是中药存在的首要特性,满足尚未满足的临床需求是中药新药研发的首要目标;而科学性是任何药品社会性的保障,故中药组方合理、机制清晰、疗效确切、安全可靠是中药新药的基本要求;合规性是药品特殊属性的基础,也是国家对新药研发的强制要求,故新药研发首先需要符合各项药政法规要求;经济性是实践药品社会性的结果,也是科学性和合规性的直接体现,疗效可靠安全性又高、满足临床需求,自然会有较好的经济性,但这是果,不是因。
Drugs as a special commodity, “safe, effective, quality control ” is its basic requirements. As an important form of medicine for preventing and treating diseases and rehabilitating health, traditional Chinese medicine should fully consider the social, scientific, compliance and economic development requirements of medicines when developing new products. Among them, sociality is the primary characteristic of traditional Chinese medicine. Satisfying unsatisfied clinical needs is the primary goal of Chinese medicine research and development. Scientific is the social guarantee of any medicine. Therefore, traditional Chinese medicine has reasonable prescription, clear mechanism, effective curative effect, safe and reliable The basic requirements of Chinese medicine new drugs; compliance is the basis of the special properties of drugs, but also the country’s mandatory requirements for research and development of new drugs, so the new drug research and development must first meet the requirements of various drug laws and regulations; economy is the result of social practice drugs, but also science The direct manifestation of sex and compliance, reliable and safe curative effect, to meet clinical needs, will naturally have better economy, but this is the result, not because of.