The newly revised Pharmaceutical Administration Law of the People’s Republic of China, as voted through by the 12th Session of 13th Standing Committee of the National People’s Congress on August 26, 2019, will come into force on December 1, 2019.
the Revision Bill was drafted to redefine the fake drugs and the inferior drugs. The original situations where a drug was handled as fake drug and inferior drug may be defined within the scopes of fake drugs and inferior drugs, or be listed separately.
The Revision Bill clearly stipulates that a fake drug has any one of the following characteristics: Its components are different from those prescribed by State pharmaceutical standards; a non-medical substance is passed off as a drug, or one drug is passed off as another; where the drug has deteriorated; where the indications or the functions marked on the labels of the pharmaceuticals do not fall within the prescribed scope.
A drug may has any one of the following characteristics: whose components do not conform in quantity to that required by State pharmaceutical standards; where the drug has been contaminated; an expiry date is not indicated or is altered; the drug has passed its expiration date; a registration number is not indicated or is altered; the drug has been added presumptuously with color or preservative additives, spice, disguising odor or supplementary materials; the drug fails to meet the prescribed standards in other respects.
