Chinese Pharmaceutical Policy Studies

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

Pharmaceutical industry regulations

  

20010228 the Law of the PRC on the Management of Medicines and             Chemical Reagents

20020915 Implementing Regulations on the Law of the PRC on         Medicines Management

 

• general principles: structural establishment;

• management of producers: application for and alteration of Drug Production License; ; GMP certification; requirements for raw materials;

• management of distributors: application for and alteration of Drug Distribution License and registration; GSP certification; qualification of employees in retail pharmacies which sell POM and OTC respectively;

• pharmaceutical management in medical facilities: application for and alteration of drug dispensing certificate of medical facilities; acquisition of approval number; qualification of pharmic technical staffs; complete and real procurement records; medicines provided by medical facilities must be prescribed to meet the drug application scopes by registered doctors or assistant doctors;

• drug management: application of GLP and GCP 

 

20060601 Regulations on Medicine Instruction and Label Management

•  INN names should be highlighted on the packages with the same fonts, colors and location; the brand name cannot be at the same row with its INN name;