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By Ryosuke Kuribayashi, Maki Matsuhama, and Kenichi Mikami

Ryosuke KuribayashiMaki MatsuhamaA generic drug is defined as a drug with the same active pharmaceutical ingredient, dosage form, strength, quality, indication, effect, direction, and dose as the original proprietary drug. Generic drug approval review in Japan is conducted by the Office of Generic Drugs, established in November 2014 as part of 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. As employees of the Office of Generic Drugs, we presently carry out various activities to change regulation of the generic drugs of Japan. We are considering the following topics:

  • Strengthening cooperation with academia, healthcare professionals, etc., to conduct consultations and reviews based on the latest medical care trends and needs, and to promote cooperation toward appropriate use of pharmaceuticals.
  • Promoting establishment of standards regarding quality of pharmaceuticals, etc., such as the Japanese Pharmacopoeia, established by the Japanese Ministry of Health, Labour, and Welfare (MHLW), in order to conduct accurate and prompt reviews.
  • Recommending application by common technical document (CTD) / eCTD format in order to increase efficiency in reviews.
  • Ensuring transparency of the reviews by preparing and disclosing review reports on new generic drugs.
  • Establishing guidelines for bioequivalence testing in order to respond to the increased complexity of bioequivalence assessments and the diverse pharmaceutical products that are being developed
  • Cooperating with relevant offices to take appropriate measures to steadily implement the risk management plan.

These topics are being announced in the third PMDA five-year mid-term plan (Fiscal year 2014–2018).

Generic drug reviews in Japan are being conducted all the time and have been for many years. However, the details of the generic drug review in Japan have not been reported. We believe the communication of regulatory policy, procedures, and issues under consideration and discussion for generic drugs in Japan is very useful to the international pharmaceutical community. Sharing these details could help shape the future of generic drugs around the world.

In a recent AAPS Journal article, Regulation of Generic Drugs in Japan: the Current Situation and Future Prospects, we introduced the application types, the number of applications and approvals, and the review timeline of generic drugs in Japan. Additionally, we introduced our consultation meetings and future prospects. This is the first report to introduce the details of generic drug regulations in Japan, and we hope it clarifies what’s happening currently and where Japan is headed in the future.

Finally, the authors wish to thank the members of the Office of Generic Drugs of PMDA for their cooperation.

Disclaimer: The views expressed in this blog are those of the authors and do not necessarily reflect the official views of the Pharmaceuticals and Medical Devices Agency.

Ryosuke Kuribayashi is a reviewer, Office of Generic Drugs at Pharmaceuticals and Medical Devices Agency (PMDA) in Japan.
Maki Matsuhama is a reviewer, Office of Generic Drugs at PMDA in Japan.
Kenichi Mikami is an office director, Office of Generic Drugs at PMDA in Japan.