china jakarta conf

8/6/2019 China Jakarta Conf

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Combating Counterfeit Drugs in ChinaCombating Counterfeit Drugs in China

Chen XuChen Xu Ph.D.Ph.D.([email protected])

Director of Division of Drug Supervision and InspectionDirector of Division of Drug Supervision and Inspection

Department of Drug Market ComplianceDepartment of Drug Market ComplianceState Food and Drug AdministrationState Food and Drug Administration

PeoplePeople¶¶s Republic of Chinas Republic of China



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What legislation is currently used for SFDA toWhat legislation is currently used for SFDA tocombating counterfeit drug?combating counterfeit drug?

China had first Drug Administration Law in 1985,whichcontained special articles for combating counterfeit drugs DrugAdministration Law was revised in 2001, provided more specificArticles for combating counterfeit drugs.

³Regulations for Implementation of Drug Administration Law´promulgated in 2002, and also contained special articles for combating counterfeit drugs.

³The State Council special regulation for strengthens food anddrug security Surveillance´ was published and implemented onJuly 25, 2007,which contained special articles for combatingcounterfeit drug too.



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Article 48(Drug law) Production (including dispensing,Article 48(Drug law) Production (including dispensing,the same below) and distribution of counterfeit drugsthe same below) and distribution of counterfeit drugsare prohibited.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 specifiedby the national drug standards; or (2) a non-drug substance is simulated as a drug or one drug issimulated as another.A drug shall be treated as a counterfeit drug in any of thefollowing cases:(1) its use is prohibited by the regulations of the drug regulatorydepartment under the State Council;(2) it is produced or imported without approval, or marketedwithout being tested, as required by this Law;(3)it is deteriorated;(4) it is contaminated;(5) it is produced by using drug substances without approvalnumber as required by this Law; or (6) the indications or functions indicated are beyond the specified

scope.



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Article 49(Drug law) Production and distribution of Article 49(Drug law) Production and distribution of substandard drugs are prohibited.substandard drugs are prohibited.

National definitions of substandard drug are followings:

A drug with content not up to the national drug standards isa substandard drug.

A drug shall be treated as a substandard drug in any of thefollowing cases;(1) the date of expiry is not indicated or is altered;(2) the batch number is not indicated or is altered;(3) it is beyond the date of expiry;(4) no approval is obtained for the immediate packagingmaterial or container;(5) colorants, preservatives, spices, flavorings or other

excipients are added without authorization; or(6) other cases where the drug standard are not conformed.



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What are gaps in current legislation and howWhat are gaps in current legislation and howto meet gaps?to meet gaps?

InIn ChinaChina,, SFDASFDA isis reresponsiblesponsible for for administrativeadministrative punishmentpunishmentonon counterfeitcounterfeit drugdrug includingincluding toto investigateinvestigate && penalizepenalize illegalillegalactivitiesactivities of of manufacturing,manufacturing, selling,selling, usingusing counterfeitcounterfeit drugs)drugs)..ButBut SFDASFDA isis notnot r rresponsibleresponsible for for criminalcriminal punishmentpunishment onon

counterfeitingcounterfeiting..InIn order order toto meetmeet thethe gaps,gaps, SFDASFDA cooperatecooperatess withwith other other

governmentgovernment bodiesbodies..

± ±workingworking withwith thethe PublicPublic SecuritySecurity MinistryMinistry for for criminalcriminalpunishmentpunishment for for manufacturingmanufacturing && sellingselling counterfeitcounterfeit drugdrugss ,,

± ±workingworking withwith PostalPostal OfficeOffice for for eliminating,eliminating, closingclosing of of mailmail

ordersorders && mailmail boxesboxes of of counterfeitcounterfeit drugsdrugs.. ± ±workingworking withwith thethe CustomsCustoms OfficeOffice toto controlcontrol of of smugglingsmugglingcounterfeitcounterfeit drugdrug..



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What is being done to fill the gaps?What is being done to fill the gaps?

Now we, SFDA has established regular and long term cooperationNow we, SFDA has established regular and long term cooperationmechanisms with the above Depts. We have established fixed office,mechanisms with the above Depts. We have established fixed office,fixed meeting timetable, fixed hot line, and so on.fixed meeting timetable, fixed hot line, and so on.

For example, during March 25, to September 25,2003 SFDA carriedFor example, during March 25, to September 25,2003 SFDA carriedout jointly by the Ministry of Public Security to combat the productionout jointly by the Ministry of Public Security to combat the productionand selling of counterfeit medicines in a nationwide scale.and selling of counterfeit medicines in a nationwide scale.

SFDA and the Ministry of Public Security had set up a special actionSFDA and the Ministry of Public Security had set up a special actionleading group in charge of this special operation commandleading group in charge of this special operation commandcoordination. The local DRA and public security also set upcoordination. The local DRA and public security also set upspecialized agencies, responsible for organization and leadership work,specialized agencies, responsible for organization and leadership work,and to identify hand, is responsible for the coordination of specialand to identify hand, is responsible for the coordination of specialaction links. This special operation, the goal is to destroy key areas of action links. This special operation, the goal is to destroy key areas of

production, selling of counterfeit medicines, and sales networks, andproduction, selling of counterfeit medicines, and sales networks, andprosecute the illegal production and sale of counterfeit criminals, andprosecute the illegal production and sale of counterfeit criminals, andto effectively check the manufacture and sale of counterfeit medicines.to effectively check the manufacture and sale of counterfeit medicines.Establish a perfect antiEstablish a perfect anti--counterfeit longcounterfeit long--term cooperation mechanismterm cooperation mechanismto purify medicine market order, and ensure the safety of the massesto purify medicine market order, and ensure the safety of the massesmedication.medication.



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If If thethe casecase of of counterfeitcounterfeit drugsdrugs accordsaccords withwith thethe demandsdemands of of criminalcriminalpunishment,punishment, DRADRA mustmust promptlypromptly transfer transfer itit toto thethe publicpublic securitysecurity bodiesbodiesaccordingaccording toto thethe stipulation,stipulation, positivelypositively coordinatescoordinates thethe judicial judicial bodiesbodies totodevelopdevelop pursuespursues thethe punishmentpunishment work,work, includingincluding collectscollects andand thetheproductionproduction of of evidenceevidence.. HasHas aa suspectsuspect clueclue of of criminalcriminal case,case, SFDASFDA mustmustproposepropose thethe publicpublic securitysecurity bodiesbodies toto involveinvolve aheadahead of of time,time, thethe

coordinationcoordination investigation,investigation, preventedprevented andand avoidsavoids thethe criminalcriminal suspectsuspect asas far far asas possiblepossible escaping,escaping, alreadyalready escapedescaped mustmust assistassist thethe publicpublic securitysecuritybodiesbodies toto seizeseize asas soonsoon asas possiblepossible bringsbrings toto justice justice..

TheThe conditionsconditions for for DRADRA toto transfer transfer counterfeitcounterfeit casecase toto thethe publicpublic securitysecuritybodybody::

(1) Individual illegal sale counterfeit drug amount 50,000 Yuan (RMB) above, or illegal obtained amount in 10,000 Yuan (RMB) above;

(2) Unit illegal sale counterfeit drug amount 500,000 Yuan (RMB) above, or illegal obtained amount in 100,000 Yuan (RMB) above;

(3) The production and sale of counterfeit drug, also sufficiently causes thehuman body serious harm, may directly carry on processing by the public securitydepartment according to the criminal law, not above amount limit.

What is being done to fill the gaps?What is being done to fill the gaps?



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What are proposal for actions of IMPACT?What are proposal for actions of IMPACT?

(1) Measures to be taken:

(a) Signing work cooperation document, making corresponding working

routine.

(b) Establishing special department, the personnel are responsible to

coordinate the routine duties.(c) Establishing the platform of information exchange, is prompt,

accurately the sharp related counterfeit information.

(2) WHO should do it?(2) WHO should do it?

(a) The coordination, management of IMPACT throughout member countries.

(3)Transsmitting information to related country.(b)Providing the essential funds, and technical supports to the various

countries.



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What are proposal for actions of IMPACT?What are proposal for actions of IMPACT?

(3)Critical factors to ensure success(3)Critical factors to ensure success

(a) The various countries' work develops and cooperates, WHOmust establish in the equal and in the cooperation foundation,does not interfere the various countries' investigation work.

(b) Information exchange provided by IMPACT system must betraceable according to the evidence which may look up.(c) Funds safeguard.

(4)Realistic timeframe(4)Realistic timeframe

After completion of above work, all participates of IMPACT canbe in motion together.

(5)(5) Cost estimateCost estimateNeeds 4 million US dollars funds budget every year in China.

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