Article 31 For production of a drug admitted by national drug standards, an application shall, in accordance with the provisions of the drug regulatory department under the State Council, be submitted to the drug regulatory department of the people’s government of the province, autonomous region or municipality directly under the Central Government or to the drug regulatory department under the State Council, and the relevant technical data and supporting documents shall be provided. The drug regulatory department of the people’s government of the province, autonomous region or municipality directly under the Central Government shall, within 30 working days from the date it receives the application, review and make comments, and report the matter to the drug regulatory department under the State Council for review while notifying the applicant of its comments. If all the requirements are fulfilled upon review, a drug approval number shall be issued by the drug regulatory department under the State Council.
Article 32 Where a drug is produced according to an interim standard, an application shall be submitted for formalization of the standard three months prior to the expiry date of the interim standard according to the provisions of the drug regulatory department under the State Council; the drug regulatory department under the State Council shall, within 12 months from the expiry date of the interim standard, review and approve the interim standard as formal one if it fulfills the requirements for the formalization set forth by the drug regulatory department under the State Council. Where an applicant does not make such an application or the original interim standard fails to fulfill the requirements for the formalization, the drug regulatory department under the State Council shall withdraw the interim standard and the approval number for drug production issued on the basis of the said interim standard.
Article 33 For alteration of any items indicated in the approval documents and their attachments for new drug research and development, production or importation of a drug, a supplementary application shall be submitted to the drug regulatory department under the State Council; if all the requirements are fulfilled upon review, an approval shall be given by the drug regulatory department under the State Council.
Article 34 The drug regulatory department under the State Council may, based on the needs for protection of public health, set an observation period of not more than five years for a new drug produced by a drug manufacturer; and no approval shall be given to any other manufacturer to produce or import the said drug during the observations period.
Article 35 The State protects undisclosed data of drug study and others which are independently acquired and submitted by drug manufacturers or sellers to obtain production or marketing approval of the drugs in question which contain new chemical entities. No one may make unfair commercial use of the said data.
Within six years from the date a drug manufacturer or seller obtains the approval documents for producing or marketing a drug containing new chemical entities, if any other applicant uses the data mentioned in the preceding paragraph to apply for approval for production or marketing of the drug in question without permission of the original applicant who has obtained the approval, no approval may be given to any other applicant by the drug regulatory department except that the data submitted are acquired independently.
No drug regulatory department may disclose the data set forth in the first paragraph of this Article except
(1) for the need of public interests; or
(2) where steps are taken to ensure that the data are protected against unfair commercial use.
Article 36 Any drug applied to be imported shall be the one obtained marketing authorization in the country or region of manufacturing. A drug without such an authorization may be approved of its importation in accordance with the provisions in the Drug Administration Law and in the Regulations, provided that its safety, efficacy and clinical needs have been confirmed by the drug regulatory department under the State Council.
For importation of a drug, an application for registration shall be made according to provisions of the drug regulatory department under the State Council. A drug may only be imported after an Import Drug License is given if it is produced by a foreign manufacturer, or a Pharmaceutical Product License is given if it is produced by a manufacturer in Hong Kong, Macao or Taiwan of China.
Article 37 Any medical institution that urgently needs to import a small amount of drugs shall, with a Practicing License of Medical Institution, submit an application to the drug regulatory department under the State Council, and the drugs in question may only be imported upon approval. Such import drugs shall only be used in the designated medical institution for specified purpose.
Article 38 After import drugs arrive at the port, the drug importer shall file a record with the local drug regulatory department in the place where the port is located with the Import Drug License or Pharmaceutical Product License, the original copy of the certificate or origin, duplicate copy of the purchase contract, packing list, bill of freight, shipping invoice, certificate of analysis for the release of drugs by the manufacturer, inset sheet and other documents. The said drug regulatory department shall review the documents submitted and issued a Drug Import Note if they comply with the requirements. The drug importer shall, with the Drug Import Note, complete the formalities for customs declaration and clearance with the Customs.
The drug regulatory department in the place where the port is located shall notify the drug testing institution to conduct sampling and testing of the import drugs on each batch basis with the exception of the circumstances set forth in Article 41 of the Drug Administration Law.
Article 39 Vaccines, blood products, diagnostic reagents in vitro for blood donor screening and other biological products regulated by the drug regulatory department under the State Council shall be subject to testing or review for approval according to the provisions of the drug regulatory department under the State Council before being marketed or imported; any product that fails in testing or has not been approved shall not be marketed or imported.
Article 40 The State encourages cultivation of Chinese crude drugs. Control through approval number shall be exercised over the Chinese crude drugs that can be cultivated or raised on a large scale and in an intensified way and whose quality can be controlled and fulfills the requirements laid down by the drug regulatory department under the State Council.
Article 41 The drug regulatory department under the State Council shall re-evaluate the drugs approved for production and marketing and, on the basis of the re-evaluation results, may take measures to order the revision of insert sheet or suspension of production, marketing or use of a drug, or withdraw the approval documents of drugs with serious adverse reaction or harmful to human health due to other reasons.
Article 42 The valid term of a drug approval number, Import Drug License and Pharmaceutical Product License issued by the drug regulatory department under the State Council is five years. To continue its drug production or importation, the applicant shall submit a re-registration application six months prior to the expiry date. When making re-registration of a drug, the applicant shall submit the relevant data according to the provisions of the drug regulatory department under the State Council. If no application for the re-registration of a drug is made upon expiration of the valid term, or the application fails to comply with the provisions on re-registration of the drug regulatory department under the State Council upon review, the drug approval number, Import Drug License or Pharmaceutical Product License shall be withdrawn.
Article 43 No contents involving prevention, treatment or diagnosis of human diseases shall be included in the package, label or insert sheet and the related promotional materials for promoting a non-drug product, except as otherwise provided by laws or administrative regulations.
Chapter VI Control over Drug Packaging
Article 44 Immediate packaging materials and containers used by drug manufacturers shall fulfill the requirements for medicinal use and the standards for ensuring human health and safety, and be subject to registration upon approval by the drug regulatory department under the State Council.
The drug regulatory department under the State Council shall be responsible for working out and issuing the measures for control over immediate packaging materials and containers, the product directories and the requirements and standards for medicinal use.
Article 45 Packaging materials and containers selected for production of prepared slices of a Chinese crude drug shall accommodate to drug properties. No prepared slices of a Chinese crude drug may be marketed whose package fails to conform to regulations. A label shall be printed on or attached to the package of prepared slices of a Chinese crude drug.
On the label of prepared slices of a Chinese crude drug shall be indicated the name of the drug, specifications, origin or production, manufacturer, product batch number and production date; if the said drug is controlled by approval number, the drug approval number shall also be indicated.
Article 46 The package, label and insert sheet of a drug shall be printed in accordance with the provisions in Article 54 of the Drug Administration Law and those formulated by the drug regulatory department under the State Council.
The trade name of a drug shall conform to the provisions of the drug regulatory department under the State Council.
Article 47 The immediate packaging materials and containers, used by medical institutions for dispensing pharmaceutical preparations, as well as the labels and insert sheets thereof, shall conform to the provisions in Chapter VI of the Drug Administration Law and the relevant provisions in the Regulations, and be subject to approval by the drug regulatory department of the people’s government of the province, autonomous region or municipality directly under the Central Government.
Chapter VII Control over Drug Pricing and Advertising
Article 48 For drug pricing, the State exercises a system under which the prices are fixed or guided by the government or regulated by the market.
For drugs listed in the directory of drugs for national basic medical insurance and drugs not listed in the directory but monopolistically manufactured and distributed, their prices shall be fixed or guided by the government; the prices of other drugs shall be regulated by the market.
Article 49 For a drug whose price is fixed or guided by the government according to law, the competent pricing department of the government shall fix and adjust its sale prices in accordance with the principle set forth in Article 55 of the Drug Administration Law; and, in fixing and adjusting its sale price, control over the average social rate of drug sales cost, drug sales profit margin, and the differential rate in drug circulation shall be manifested. The specific pricing measures shall be formulated by the competent pricing department under the State Council in accordance with the relevant provisions in the Pricing Law of the People’s Republic of China (hereinafter referred to as the Pricing Law).
Article 50 For a drug whose price shall be fixed or guided by the government and is so established, the competent pricing department shall publish the said price and specify the date for going into effect in designated publications in accordance with the provisions in article 24 of the Pricing Law.
Article 51 For a drug whose price is fixed or guided by the government, the competent pricing department shall, in fixing or adjusting the price, organize experts in pharmaceutical, medical, economic and other fields to conduct assessment; and, if necessary, it shall solicit comments from drug manufacturers, drug distributors, medical institutions, citizens and other relevant units and persons.
Article 52 The 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 53 For 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 or 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 or 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 concurrently. 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 or municipality directly under the Central Government where the drug import agency is located, in accordance with the provisions in the preceding paragraph of this Article.
For publishing an advertisement in a province, autonomous region or municipality directly under the Central Government other than the place where the drug manufacturer or drug import agency is located, any 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 record finds that the approved contents of the drug advertisement does not conform to the provisions on the control of drug advertisement, it shall turn over the matter to the original verifying and issuing department for handling.
Article 54 For 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 or 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 55 Any enterprise publishing advertisement, advertising agent or advertisement publisher shall immediately discontinue the publication of any drug advertisement without approval by the drug regulatory department of the people’s government of the province, autonomous region or 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 or municipality directly under the Central Government may announce the matter to the public.
Chapter VIII Inspection of Drugs
Article 56 The Drug regulatory department (including the drug regulatory institution legally established by the drug regulatory department of the people’s government of the province, autonomous region or municipality 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 57 Sampling 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 may 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 or municipality directly under the Central Government where it is located may announce a stop to marketing and use of the drug, of which the sampling and testing are refused.
Article 58 Where a drug is suspected of being impure or adulterated but unable to be tested by 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 59 The drug regulatory department under the State Council and the drug regulatory department of the people’s government of the province, autonomous region or municipality directly under the Central Government shall regularly make announcements on drug quality according to the results of sampling and testing. In a 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, and 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 to the drug testing institution responsible for re-testing. The sample for re-testing shall be taken form the retaining sample kept by the original testing institution.
Article 60 Where 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.
