Regulatory Strategy in Japan
Regulatory Strategy for Medical Devices in Japan (dMAH)
Regulatory Strategy for Pharmaceuticals/Drugs in Japan (dMAH)
Developing your Japanese regulatory strategy can be complex because of the very strict regulations in Japan and the high costs of doing business there. Issues like product registration, good manufacturing practice (GMP), quality assurance (QA), and reimbursement issues are highly regulated. The regulations in Japan, however, can be vague or difficult to understand. For example, it is often uncertain whether the Japanese government will accept foreign clinical data. If the government does require local clinical data, then you must figure out the size, cost, and timing for doing clinical trials in Japan.
Physicians, who enjoy a very high social status in Japan, are crucial to help you succeed there. It is important, however, to choose the right key opinion leaders (KOLs) in the Japanese medical community to support your medical product. In some cases, your KOLs might be supporting a competing product without your knowledge.
Determining what reimbursement status your product will have in Japan is also key to your success. Depending on the nature of your product, you may decide to use an existing reimbursement category to get on the market more quickly. Alternatively, if you have more time, you may try for a new category with higher reimbursement.
PBM's regulatory experts can help your company determine the most cost-effective and time-efficient regulatory strategy for Japan.
PBM can act as your dMAH in Japan.
For more information on regulatory issues in Japan, please see the following PBM publications and/or contact us to discuss your specific needs.
