How long does it take for generic companies to obtain MA from the filing of an application for MA?

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Generic companies generally need MA (Marketing Approval) to sell its generics in Japan.  Further, generic companies also need NHI (National Health Insurance) price listing to sell its generics at competitive price.

For generics, an opportunity for NHI price listing is only twice a year, currently, June and December.

For June NHI Price Listing, only Marketing Approval given by a reference date (which is announced every year) in February.

For December NHI Price listing, only Marketing Approval given by a reference date (which is announced every year) in August.

Although Marketing Approval for generic drugs can technically be given all through the year, however, for the reason above, most of them are given in February or August.

It generally takes at least a year for generic companies to obtain MA from the filing of an application for MA.

This means that, generally, “Filing of MA” between February in “YEAR 1″ and July in “YEAR 1″ will be given MA in (or by) August in “YEAR 2″ and will be listed in NHI price listing in December “YEAR 2″.

Similarly, generally, “Filing of MA” between August in “YEAR 1″ and January in “YEAR 2″ will be given MA in (or by) February in “YEAR 3″ and will be listed in NHI price listing in June “YEAR 3″.

Thus it should take 17 – 22 months for generic companies to obtain NHI price listing from the filing of an application for MA.

However, the time can vary depending on various factors (such as amount of additional information requested by an authority).

For further questions, please contact us.

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