Kuribayashi Ryosuke, Matsuhama Maki, Mikami Kenichi
Office of Generic Drugs, Pharmaceuticals and Medical Devices Agency, 3-3-2, Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013, Japan,
AAPS J. 2015 Sep;17(5):1312-6. doi: 10.1208/s12248-015-9777-x. Epub 2015 May 6.
Generic drugs are interchangeable with original proprietary drugs, as they have the same active pharmaceutical ingredients, dosage forms, strength, quality, indications, effects, directions, and dosage. The cost of generic drugs is lower than original drugs, because the developmental cost is lower. The expansion of medical expenses is an important issue in many countries, including Japan, the USA, and Europe, and promotion of generic drugs has been demanded to solve this issue in Japan. Generic drug approval review in Japan is conducted by the Pharmaceuticals and Medical Devices Agency (PMDA), which reviews the equivalence of the original drugs from the viewpoint of quality, efficacy, and safety, based on documentation submitted by the generic drug applicants. However, the details of the generic drug review in Japan have not been reported. In this report, we introduce the application types, the number of applications and approvals, and the review timeline of generic drugs in Japan. In addition, we discuss recent consultations and future prospects.
仿制药与原研专利药可互换，因为它们具有相同的活性药物成分、剂型、强度、质量、适应症、效果、用法和用量。仿制药的成本低于原研药，因为其研发成本较低。医疗费用的增长是包括日本、美国和欧洲在内的许多国家的一个重要问题，在日本，人们要求推广仿制药以解决这一问题。日本的仿制药批准审查由药品和医疗器械局（PMDA）进行，该局根据仿制药申请人提交的文件，从质量、疗效和安全性的角度审查原研药的等效性。然而，日本仿制药审查的细节尚未报道。在本报告中，我们介绍了日本仿制药的申请类型、申请和批准数量以及审查时间表。此外，我们还讨论了近期的咨询情况和未来前景。
