Japan Drug Regulation and Strategy for Drug Approval Process
Read on to learn more about the Japan drug approval process and find out how PBM's pharmaceutical consultants can help to expedite it.
Japan Drug Approval Process
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.
PBM can act as your dMAH in Japan.
Contact PBM Today
Do you need help with the Japan drug approval process in Japan? Contact PBM today for a free consultation to help you attain a Japan drug regulation strategy that moves your business forward.
Need more information? Please see the following PBM publications to learn more about regulations affecting the Japanese pharmaceutical market.
Go back to the PacificBridgeMedical.com homepage
- Japan Medical Device Regulatory Updates 2013
- 2013 Japan Business Culture
- 2012 Japan Medical Device Product Registration and Regulatory Updates
- 2011 Strategies for Success in China, Japan, and India
- 2011 Japan Medical Device Updates
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