Combating Counterfeit Drugs in China.ppt

Combating Counterfeit Drugs in China Chen Xu Ph.D. (chenxu@sfda.gov.cn) Director of Division of Drug Supervision and Inspection Department of Drug Market ComplianceState Food and Drug AdministrationPeople’s Republic of China? What legislation is currently used for SFDA to combating counterfeit drug? China had first Drug Administration Law in 1985,which contained special articles for combating counterfeit drugs Drug Administration Law was revised in 2001, provided more specific Articles for combating counterfeit drugs. “Regulations for Implementation of Drug Administration Law” promulgated in 2002, and also contained special articles for combating counterfeit drugs. “The State Council special regulation for strengthens food and drug security Surveillance” was published and implemented on July 25, 2007,which contained special articles for combating counterfeit drug too. ? Article 48(Drug law) Production (including dispensing, the same below) and distribution of counterfeit drugs are prohibited. National definitions of counterfeit drug are followings: A drug is a counterfeit drug in any of the following cases: (1) the ingredients in the drug are different from those specified by the national drug standards; or (2) a non-drug substance is simulated as a drug or one drug is simulated as another.A drug shall be treated as a counterfeit drug in any of the following cases:(1) its use is prohibited by the regulations of the drug regulatory department under the State Council;(2) it is produced or imported without approval, or marketed without being tested, as required by this Law;(3)it is deteriorated;(4)?it is contaminated;(5)?it is produced by using drug substances without approval number as required by this Law; or (6)?the indications or functions indicated are beyond the specified scope. Article 49(Drug law) Production and distribution of substandard drugs are prohibited. National definitions of substandard drug are followings: A drug wit