Pharmaceutical/Drug Registration in Japan

The Japan pharmaceutical/drug market is about $60 billion. The regulator of medical devices and pharmaceuticals in Japan is the Pharmaceuticals and Medical Devices Agency (PMDA), which handles pharmaceutical/drug registration. Other Japanese medical issues, such as hospitals, health insurance, and medical product registration policy, are handled by the Ministry of Health, Labor and Welfare (MHLW).

There are different kinds of drug applications, depending on if the drug is a completely new substance or similar to a predicate drug. In the situation that it is a completely new drug, the PMDA will require quality testing, pre-clinical testing, and other data. The kinds of information the PMDA will review for the drug application include development history, origin, usage in other countries, stability data, manufacturing processes, etc.

PBM can act as your designated Marketing Authorization Holder, or D-MAH.

Japan has a Master File (MF) system for drug substances which allows Japanese or foreign manufacturers voluntarily register their data concerning the quality/manufacturing methods of their products directly to the reivew authority. MF submission allows for protection of intellectual property. The type of information that can be registered in an MF include manufacturing methods, manufacturing process control, specifications and test methods, information on safety, etc.

For more information on pharmaceutical/drug registration in Japan, please see the following PBM publications and/or contact us to discuss your specific needs.

Contract Research Organizations in Asia 2011 (publication for sale)
Orphan Drugs in Asia: Guidelines and Regulatory Requirements 2011 (publication for sale)
Strategies for Success in China, Japan, and India (webcast for sale)
How to Get the Right Regulatory Assistance in Japan
Direct Registration of Medical Products in Japan: A Case Study