Chinese Pharmaceutical Policy Studies

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Drug procurement through central tender   //  Pharmaceutical commerce  // Drugs used in community   // Drug pricing and prices   //  Hospital regulations  //
Pharmaceutical industry   // New rural cooperative medical services // Prescription  // Urban employees' basic medical insurance   // Sectors combination



20000101 Regulations on Classified Management of Prescription Drugs and OTC


Ÿ            separate POM and OTC based on the medicine categories, formulation, application symptom, dosage and administration route;

Ÿ            POM have to be distributed, purchased and consumed with the prescription by licensed doctors or associate doctors;

Ÿ            national drug administration is responsible for establishing POM and OTC sort management and provincial drug administrations are in charge of the implementation, audit and management of the sort management;

Ÿ            SFDA is responsible for the selection, examining and approval, issue and adjustment of OTC drug list;

Ÿ            instructions and labels for OTC should be easily understandable with designated marks, even on each unit;

Ÿ            OTC are divided to A-class and B-class according to drug safety:

Ÿ            consumers can purchase OTC by themselves;

Ÿ            POM can advertise only on professional medical newspaper and journals; OTC can advertise on mass media after approval;


20070326 Notice on Non-proprietary Names of Commonly Prescribed Drugs


Ÿ            including 1029 drugs in 26 categories and 93 sub-categories;

Ÿ            don’t include regulations on base, formulation and dosage


20070501 Prescription Management Methods


Ÿ            definition of prescription

Ÿ            general regulations: standard prescription, requirements and styles;

Ÿ            qualification of prescriber and for prescribing narcotic drugs and the first-class psychotropic substances;

Ÿ            prescription:

Ÿ            distribution of prescription:

Ÿ            audit and management

Ÿ           legislation responsibility

Ÿ           annex: prescription evaluation form: including average numbers of medicines, percentage of antibiotics; percentage of injection; percentage of essential drugs, percentage of INN prescribed, average values per prescription, average attendance time per patient, average distribution time,, percentage of actual distribution according to prescription, percentage of completeness rate of medicine indication and the availability of formulary and EDL;  

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