Understanding Patent Process for Generics and Biosimilars in Japan

Understanding Patent Process for Generics and Biosimilars in Japan

If you are planning to register a generic or biosimilar drug in Japan, it is essential to understand the country’s two-stage patent linkage system, that operates through Ministry of Health, Labor, and Welfare (MHLW) administrative notices rather than formal regulations. The First Stage ensures generic drugs do not infringe on brand patents during regulatory review.

Supporting the Development of Regenerative Medical Products for Rare Diseases

Supporting the Development of Regenerative Medical Products for Rare Diseases

Japan, the Orphan Drug Designation (ODD) system is designed to promote the development of treatments for rare diseases, including regenerative medical products. Regenerative medical products, which encompass therapies aimed at repairing or replacing damaged tissues or organs, can qualify for ODD if they meet specific criteria.

Japan Updates Orphan Drug Designation System to Accelerate Treatments for Rare Diseases

Supporting the Development of Regenerative Medical Products for Rare Diseases

Japan has recently implemented significant updates to its Orphan Drug Designation (ODD) system, aiming to foster the development of treatments for rare diseases. These changes, introduced in 2024, are designed to streamline the designation process, provide robust support to pharmaceutical companies, and expedite patient access to essential medications.

REGISTRATION OF DRUG MASTER FILE (DMF) IN JAPAN

In Japan, the Drug Master File (DMF) is called “Master File” or “MF”. The Purpose of DMF is to protect the “know-how” of API manufacturing methods against the marketing authorization applicant (MAA) / holder (MAH) of pharmaceutical products.  The foreign manufacturers of APIs can apply for DMF registration.

Japan’s PMDA Remote Inspections

The PMDA clarifies its requirements for conducting remote compliance inspections related to drugs and regenerative medical products.