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Legislation: New definition of counterfeit drugs given by the Chinese FDA

Legislation: New definition of counterfeit drugs given by the Chinese FDA


Sda.gov.cn


The CFDA bureau published a new definition of counterfeited drugs. According to this new standard, the drug is considered as counterfeited if:

1) The drug’s component does not match the national standards;

2) The medicines are mislabelled;

3) The drug is made with a material prohibited by the drug regulatory department of the State Council;

4) The drug did not receive approval licence, or the imported drug was not tested;

5) The drug is banned by the State Council;

6) The medicine is deteriorated;

7) The drug is contaminated;

8) The drug uses API that are not approved by the Drug Administration;

9) The medicine’s indications or effects are note in the range of the relevant regulation.

 

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