透皮贴剂仿制药研发和监管考量

R&D of generic transdermal patches and regulatory considerations

自首个透皮贴剂东莨菪碱透皮贴剂于1979年由FDA批准上市以来,透皮贴剂已有40多年的临床应用历史。因其制剂的特点,在规格标示、仿制药要求等方面不同于其他剂型的制剂。本文就国内外上市透皮贴剂、欧美透皮贴剂的一般要求和仿制药的技术要求以及透皮贴剂仿制药的开发等进行综述,探讨我国透皮贴剂存在的问题并提出建议,为我国透皮贴剂仿制药的研发和监管提供参考。

Since the first transdermal patch,TRANSDERM SCōP(scopolamine transdermal system),was approved by the FDA in 1979,transdermal patches have been used in clinic for 40 years.The strength definition and the requirements for generic transdermal patches are different from other dosage forms due to their characteristics.This paper reviewed the domestic and overseas approved transdermal patches,the general requirements for transdermal patches and requirements for generic transdermal patches in the European Union and the United States,and R&D of the generic drugs,also discussed the problems of transdermal patches in China and gave recommendations,to provide references for the R&D and administration of generic transdermal patches in China.