China -  Chinese law firm

How does the SDA classify pharmaceuticals in China?

Pharmaceuticals are divided into the following separate categories depending on their patent status and their classification under China's regulatory system, with pricing methods and profit margins set accordingly:

Class I: Invented, developed and manufactured in China;
Class II: Phase I and II pf clinical trials are undertaken in China; there will be a three-year period of "relaxed" pricing from the date of marketing approval;
Class III, IV and V are similarly classified by origin, type and function.
Products in all categories will be able to retain their original official profit ratio for a five-year period after any applicable protection period expires.

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