Generic Drug Product Development in Japan: Regulatory Updates During 2014-2019 and the Future.

The growth of healthcare cost is a serious issue in many countries. Generic drug products play an essential role in reducing healthcare costs because they are less costly than the innovator drug products. The regulatory review of generic drug products in Japan is conducted by the Pharmaceuticals and Medical Devices Agency (PMDA). This report introduces the activities of the PMDA from fiscal years 2014-2019. The number of approvals of new generic drug products and partial changes was trending downward. Alternatively, the PMDA conducted six types of consultation meetings to advise on development and application; the number of consultation meetings was increasing. Moreover, during this period, the Ministry of Health, Labour and Welfare issued two basic principles for ophthalmic dosage forms and dry powder inhaler drug products and revised the guidelines for bioequivalence. Finally, the future of generic drug product development and considerations to improve their regulation were discussed. More efforts will continue to enable a more efficient and rational generic drug product development and shortening of the review period for partial change approval.

Current Understanding of the Equivalence Evaluations for In Vitro Tests on Generic Dry Powder Inhaler Drug Products in Japan.

The Japanese Ministry of Health, Labour and Welfare issued the basic principles for bioequivalence evaluations of generic dry powder inhaler (DPI) drug products in 2016. This document presents the recommendations of the methodology for the effective development of generic DPI drug products. Based on this document, the Pharmaceuticals and Medical Devices Agency (PMDA) advises the efficient development in the consultation meeting with generic companies. The PMDA generally requires the data of in vitro tests, pharmacokinetics studies, and clinical endpoint studies for generic development. In vitro tests play a critical role in the development of the generic versions because these tests are used to predict the efficacy and safety of other populations on whom clinical endpoint studies have not been conducted. We are aware that some points need further discussion, such as the recommendations for at least four groups of stages (group 1: the induction port and pre-separator, group 2: greater than 5 µm, group 3: ranging from 3 to 5 µm, group 4: ranging from 0.8 to 3 µm) for in vitro tests of the generic DPI products. This article shows the current understanding and recommendations with respect to in vitro tests, particularly for at least four groups of stages.