How long is PMS (Post Marketing Surveillance) period in Japan?

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In Japan, we have Post Marketing Surveillance (PMS) system, which serves somewhat like data exclusivity in the US and Europe.

The standard period for Post Marketing Surveillance (PMS) is currently as follows.  However, they are not “per se ” rule.  Therefore, how you characterize your product in the negotiatio with MHLW is sometimes becomes important to maximize or adjust PMS period to secure best protection.

New Drug Substances

:8 years from the date of Marketing Approval

Note that PME period for New Drug Substances was previously 6 years but NOTICE FROM MHLW on April 1st, 2007 announced its policy change to give 8 year PMS period for New Drug Substances. The NOTICE also announced that New Drug Substances already approved after April 1st, 2001 would be given another 2 year PMS period so that it would be 8 years in total.

Orphan Drug

:10 years from the date of Marketing Approval

New Route of Administration

:6 years from the date of Marketing Approval

New Indication

:4 years from the date of Marketing Approval

New Dose

:4 years from the date of Marketing Approval

New Combination

:4-6 years from the date of Marketing Approval

 

Should you have any questions, please let us know.

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