Article 52The competent pricing department of the government may, in practicing drug price monitoring according to the provisions in Article 28 of the Pricing Law, appoint certain drug manufactures, drug distributors and medical institutions as drug price monitoring units for the purpose of understanding and analyzing the changes and trends of drug prices; the appointed units shall provide cooperation, support and truthful information.

Article 53For publishing a drug advertisement, the relevant materials shall be submitted to the local drug regulatory department of the people's government of the province, autonomous region and municipality directly under the Central Government where the drug manufacturer is located. The drug regulatory department of the people's government of the province, autonomous region and municipality directly under the Central Government shall, within ten working days after it receives the relevant materials, make a decision upon review on whether to issue the approval number for drug advertisement. Where the approval number for drug advertisement is issued upon review, a record shall be filed with the drug regulatory department under the State Council. The specific measures for drug advertisement shall be formulated by the drug regulatory department under the State Council.

For publishing an advertisement for an import drug, an application for approval number for drug advertisement shall be submitted to the local drug regulatory department of the people's government of the province, autonomous region and municipality directly under the Central Government where the import agency is located, in accordance with the provisions in the preceding paragraph of this Article.

For publishing an advertisement in the province, autonomous region or municipality directly under the Central Government other than where the drug manufacturer or import agency is located, the enterprise publishing advertisement shall file a record in advance with the drug regulatory department of the province, autonomous region or municipality directly under the Central Government where the advertisement is to be published. If the drug regulatory department of the province, autonomous region or municipality directly under the Central Government accepting the file finds that the approved contents of the drug advertisement does not conform to the regulations on the control of drug advertisement, it shall turn over the matter to the original verifying and issuing department for handling.

Article 54For a drug whose production, marketing or use is ordered to be suspended upon decision of the drug regulatory department under the State Council or of the drug regulatory department of the people's government of the province, autonomous region and municipality directly under the Central Government, no advertisement for the drug may be published during the period of suspension; where such an advertisement is already published, the publication shall be discontinued immediately.

Article 55Enterprises publishing advertisements, advertising agents and advertisement publishers shall discontinue immediately the publication of any drug advertisement without approval by the drug regulatory department of the people's government of the province, autonomous region and municipality directly under the Central Government, or whose approval number for drug advertisement is forged, or belongs to others, or is expired, or, whose approval number for drug advertisement is canceled because of other illegal advertising activities.

Where a drug advertisement is published in violation of law and the circumstances are serious, the drug regulatory department of the people's government of the province, autonomous region and municipality directly under the Central Government may announce the matter to the public.

Chapter VIII Inspection of Drugs

Article 56Drug regulatory departments (including drug regulatory institutions legally established by drug regulatory departments of the people's governments of the provinces, autonomous regions and municipalities directly under the Central Government, the same below) shall supervise and inspect the research and development, production, distribution and use of drugs in accordance with law.

Article 57Sampling of a drug shall be conducted by two or more persons who are responsible for drug supervision and inspection in accordance with the provisions of the drug regulatory department under the State Council.

The party whose drug is to be sampled shall provide samples of the drug for testing and shall not refuse.

Where the party whose drug is to be sampled refuses the sampling and testing of the drug without justifiable reasons, the drug regulatory department under the State Council and the drug regulatory department of the people's government of the province, autonomous region and municipality directly under the Central Government where it is located may announce a stop of marketing and use of the drug, of which the sampling and testing are refused.

Article 58Where a drug is suspected of being impure or adulterated but unable to be tested by the testing method and through the testing items prescribed in the national drug standards, the drug testing institution may conduct tests by adding testing methods and items upon approval by the drug regulatory department under the State Council, the testing results obtained by using the additional testing methods and items may be taken as the basis for certifying the quality of the drugs.

Article 59The drug regulatory department under the State Council and the drug regulatory departments of the people's governments of the provinces, autonomous regions and municipalities directly under the Central Government shall regularly make announcement on drug quality according to the testing results of samples. In the drug quality announcement shall be included the names of sampled drugs, sources of the samples, their manufacturers, batch numbers, drug strength, testing institutions, drug specifications, results of testing, items failing to pass the test, etc. If a drug quality announcement is improperly made, the department making the announcement shall, within five days from the date of recognition of the improper announcement, make a correction within the scope in which the original one is made.

Where the party has any objection to the results of testing conducted by the drug testing institution and applies for re-testing, it shall submit a written application and the original testing report attached to the drug testing institution responsible for re-testing. The samples for re-testing shall be taken from the retaining samples kept by the original testing institution.

Article 60Where the drug regulatory department takes administrative enforcement measures to seal or seize drugs that have been proved potentially harmful to human health and the related evidentiary materials, it shall, within seven days from the date it takes such measures, make a decision on whether or not to file a case; where it is necessary to test such drugs, it shall, within 15 days from the date the testing report is issued, make a decision whether or not to file a case; where the conditions for filing a case are not met, the administrative enforcement measures shall be withdrawn; where the marketing and use of such drugs need to be suspended, a decision shall be made by the drug regulatory department under the State Council or the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government.

Article 61No fees may be charged for selective drug sampling and testing.

Where the party has any objection to the results of testing conducted by the drug testing institution and applies for re-testing, it shall pay in advance the fees for drug testing to the drug testing institution responsible for the re-testing according to the regulations of the drug regulatory department under the State Council or of the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government. If the results of re-testing are inconsistent with the original testing results, the fees for the re-testing shall be paid by the original testing institution.

Article 62Fees may be collected for certificate issuance, drug registration, drug certification, drug testing for approval and mandatory drug testing according to the provisions of the Drug Administration Law and in the Regulations. The specific standards for collecting fees shall be formulated by the finance department under the State Council and the competent department for pricing under the State Council.

Chapter IX Legal Liability

Article 63A drug manufacturer or distributor shall be punished by the drug regulatory department according to the provisions in Article 79 of the Drug Administration Law under any of the following circumstances:

(1) where any newly-established drug manufacturer or any manufacturer with a newly-built workshop or with newly-added dosage forms fails in the GMP certification within the time limit prescribed by the drug regulatory department under the State Council but is still engaged in drug production

(2) where any newly-established drug distributor fails in GSP certification within the time limit prescribed by the drug regulatory department under the State Council but is still engaged in drug distribution.

Article 64Any contract giver or acceptor, in violation of the provisions in Article 13 of the Drug Administration Law, giving or accepting the contract for drug production without authorization shall be punished in accordance with the provisions in Article 74 of the Drug Administration Law.

Article 65Where, without approval, anyone who sets up a store to sell drugs at the town or country fairs, or sells drugs in a store at the fairs beyond the approved scope of drug distribution, shall be punished according to the provisions in Article 73 of the Drug Administration Law.

Article 66Any medical institution that uses pharmaceutical preparations dispensed by other medical institutions without approval shall be punished according to the provisions in Article 80 of the Drug Administration Law.

Article 67Any out-patient department, clinic or other medical institution, which are set up by individuals, if providing patients with drugs beyond the defined scope or kinds of drugs, shall be punished according to the provisions in Article 73 of the Drug Administration Law.

Article 68Any medical institution that uses counterfeit and substandard drugs shall be punished according to the provisions in Articles 74 and 75 of the Drug Administration Law.

Article 69Any institution, in violation of the provisions in Article 29 of the Drug Administration Law, conducting a drug clinical trial without approval shall be punished according to the provisions in Article 79 of the Drug Administration Law.

Article 70Where an applicant, in applying for conducting a drug clinical trail, submits false data on drug production procedures, quality specifications, or results of pharmacological and toxicological studies, etc., or submit fraud samples, the drug regulatory department under the State Council shall disapprove the application and give a warning to the applicant; where the circumstances are serious, no application for clinical trial of the said drug submitted by the said applicant may be accepted within three years.

Article 71Where anyone producing prepared slices of Chinese crude drugs without national drug standard fails to comply with the processing procedures formulated by the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government, or any medical institution dispensing pharmaceutical preparations fails to comply with the standards approved by the drug regulatory department of the people's government of the province, autonomous region and municipality directly under the Central Government, punishment shall be imposed thereupon according to the provisions in Article 75 of the Drug Administration Law.

Article 72Where the drug regulatory department and its staff members, in violation of regulations, release undisclosed experimental data or other materials submitted by a manufacturer or seller for obtaining approval of production or marketing of a drug containing new chemical entities, thus resulting in losses to the applicant, the drug regulatory department shall be liable for compensation in accordance with law. After compensating the losses, the drug regulatory department shall order the staff members who disclose the said data in purpose or have serious negligence to partially or fully bear the compensation and shall also impose administrative sanctions on those who are directly liable therefor.

Article 73Any drug manufacturer or distributor producing or distributing drugs or any medical institution dispensing pharmaceutical preparations, whose package, labels or insert sheets are in violation of the provisions in the Drug Administration Law and in the Regulations, shall be punished according to the provisions in Article 86 of the Drug Administration Law.

Article 74Any drug manufacturer, distributor or medical institution altering any items licensed for manufacturing，distributing, or dispensing drugs without completing the formalities for registration of alteration as required shall be given a warning by the original certificate-issuing department and be ordered to complete the said formalities within a time limit. Its Drug Manufacturing Certificate, Drug Distribution Certificate or Pharmaceutical Preparation Certificate for Medical Institution shall be announced as nullified if it fails to do so within the time limit, and punishment shall be given according to the provisions in Article 73 of the Drug Administration Law if it continues its production and distribution activities.