(Urgent, Ji Jia Ge No. [2000] 2144, November 21, 2000)
To Development and Planning Authorities, Price Bureaus of Each Province, Autonomous Region, Municipal City:
This Regulation for the Application and Evaluation of Government Pricing of Drugs is promulgated according to the Guidelines for Drug Price Administration Reform issued by SDPC in order to standardize the pricing procedures for drugs subject to government pricing and improve the efficiency of government pricing.
This Regulation shall be effective from December 25, 2000. Please report any problems encountered in the implementation to the Price Department of SDPC.
Regulation for the Application and Evaluation of Government Pricing of Drugs
Article 1: In order to standardize the pricing procedures for drugs subject to government pricing, this Regulation for the Application and Evaluation of Government Pricing of Drugs (hereinafter this Regulation) is hereby promulgated according to the Guidelines for Drug Price Administration Reform issued by SDPC and other relevant regulations.
Article 2: For a drug on the List of Drugs to be Priced by SDPC which is to be sold in China for the first time, the drug manufacturer or distributor shall submit an application for government pricing to the relevant provincial price bureau for evaluation. After evaluation the provincial price bureau shall submit the application to SDPC. For a drug on a list of drugs to be priced by a province which drug is to be sold in China for the first time, the drug manufacturer or distributor shall submit a price application to the provincial price bureau.
Article 3: For a drug that has already been sold in China and is on the price list of SDPC or that of a provincial price bureau, the drug manufacturer or distributor shall not submit an application for pricing. The relevant price bureau shall determine the drug price according to relevant market research information. The drug may be temporarily sold at its original price before a new price is set.
Article 4: Regarding drugs on patent and Class I and II new drugs not included in the National Drug List for Basic Medical Insurance, for those in pilot production, the price of the drug shall be initially evaluated by the provincial price bureau with jurisdiction over the manufacturing site, which initial evaluation shall then be transferred to SDPC for approval. If the drug is not under pilot production, then one year after obtaining government approval for formal production or an import drug license for the first time, the drug manufacturer or distributor shall submit the price of the drug to the provincial price bureau for initial evaluation before it is submitted to SDPC for approval.
Before selling a drug during the trial sale period, the manufacturer or distributor shall first file its self-determined price with SDPC and the provincial price bureau. Then, upon completion of the trial sale period, SDPC shall approve a price.
Article 5: For a domestic manufactured drug or a repackaged import drug, the manufacturer shall apply or file the drug price with the provincial drug price bureau with jurisdiction over the manufacturing site. For an import drug, its domestic agent or distributor shall apply or file the drug price with the provincial drug price bureau with jurisdiction over the agent or distributor or jurisdiction over the port of entry.
Article 6: In principle, the prices of the same kind of drug shall be reviewed and revised once a year. Price bureaus may timely adjust drug prices based on actual drug transaction prices and other relevant factors. According to the market situation of supply and demand and changes to the manufacturing cost of a drug, its manufacturer may also apply for price adjustment to the authorized price administration authority.
Article 7: An application report by an enterprise to set or adjust price of a drug shall include basic information of the drug, cost, recommended drug price, and reasons to support the recommendation. Relevant manufacturing, distribution and financial documents about the drug shall also be attached to the application (See Attachment I and II).
Article 8: Upon receipt of an application from a drug manufacturer or distributor to set or adjust the price of a drug, which price is administered by a provincial price bureau, the provincial price bureau shall organize relevant experts to review the application and determine or adjust the drug price with reference to the experts' opinions within 25 working days. For a drug that is subject to SDPC pricing, after examining and evaluating the application documents submitted by the manufacturer or distributor of the drug, the provincial price bureau shall submit the application to SDPC within 15 working days from receipt of the application. Delay caused by the enterprise's failure to submit application documents according to relevant requirements and the time needed to submit supplemental documents shall not count.
Article 9: The report submitted by a provincial price bureau to SDPC shall include a brief introduction of the drug for which application is made to set or adjust price, the findings related to the examination and evaluation of the application documents, recommendations regarding the setting or adjustment to the price and other relevant information.
Article 10: Upon receipt of the report to set or adjust the price for a drug from a provincial price bureau, SDPC shall organize drug price evaluation experts to review the report, and evaluate the application while referring to the expert opinions. The above work shall be completed within 25 working days from the receipt of the application. Delay caused by the enterprise's failure to submit application documents according to relevant requirements and the time needed to submit supplemental documents shall not count.
Article 11: Application and approval procedures for independent drug pricing shall be according to the relevant requirements of the Evaluation for Independent Drug Pricing.
Article 12: Regarding a drug which price shall be administered by a provincial price bureau, the provincial price bureau shall inform the applicant of the price of the drug by a written official document, file the price with SDPC, and publish the price in the designated media. Regarding a drug which price shall be administered by SDPC, SDPC shall respond to the relevant provincial price bureau by a written official document, also notifying the provincial price bureau through e-mail, and publish the price in the designated media.
For "Application Requirements to Set or Adjust, or File the Price of a Domestic Drug", Please Click here
For "Application Requirements to Set or Adjust or File the Price of an Import (Repackaged Import) Drug", Please Click here"
