Japan Drug Regulation and Strategy for Drug Approval Process

The Japanese pharmaceutical market is about $60 billion. Choosing the right Japan drug regulation strategy is one of the major keys to your success.

Foreign manufacturers can decide to either utilize a distributor, appoint a designated marketing authorization holder (DMAH), or set up their own MAH in Japan. Deciding on which strategy to choose will depend on the demand for your drug, your budget, and whether the manufacturer is interested in having the drug registrations in their own name.

There are different kinds of data requirements depending on the type of drug. The drug types are classified into categories such as a new active ingredient drug that has never been manufactured or marketed in Japan before, a drug that demonstrates new efficacy, new formulation, etc.

Japan has a Drug Master File (DMF) system for drug substances which allows Japanese or foreign manufacturers to voluntarily register their data concerning the quality/manufacturing methods of their products directly to the MHLW. DMF submission allows for protection of intellectual property.

For more information on drug regulation issues, including the Japan drug approval process, 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)
Foreign Manufacturer Accreditation for Drugs (webcast for sale)
Strategies for Success in China, Japan and India (webcast for sale)
How to Get the Right Regulatory Assistance in Japan