Laws of the People's Republic of China

Whole Document PHARMACEUTICAL ADMINISTRATION LAW OF THE PEOPLE'S REPUBLIC OFCHINA(Adopted at the Seventh Meeting of the Standing Committee of theSixth National People's Congress, promulgated by Order No. 18 of thePresident of the People's Republic of China on September 20, 1984, andeffective as of July 1, 1985)

ContentsChapter I General ProvisionsChapter II Administration of Pharmaceutical Producing EnterprisesChapter III Administration of Pharmaceutical Trading EnterprisesChapter IV Administration of Pharmaceuticals at Medical UnitsChapter V Pharmaceutical AdministrationChapter VI Packaging and Repackaging of PharmaceuticalsChapter VII Pharmaceuticals Under Special ControlChapter VIII Administration of Trademarks and Advertisements of

PharmaceuticalsChapter IX Supervision over PharmaceuticalsChapter X Legal ResponsibilityChapter XI Supplementary Provisions

Chapter I General ProvisionsArticle 1This Law is formulated with a view to enhancing the supervision andcontrol of pharmaceuticals, ensuring their quality, improving theircurative effects, guaranteeing safety in medication and safeguarding thehealth of the people.Article 2The administrative department of health under the State Council shall beresponsible for the supervision and control of pharmaceuticals throughoutthe country.Article 3The state shall develop both modern and traditional medicines and givefull play to their role in the prevention and treatment of diseases and inhealth care. The state shall protect the resources of wild medicinalmaterials and encourage the domestic cultivation of Chinese traditionalmedicinal crops.

Chapter II Administration of Pharmaceutical Producing EnterprisesArticle 4The establishment of a pharmaceutical producing enterprise must besanctioned by the competent authorities for the production and trading ofpharmaceuticals of the province, autonomous region, or municipalitydirectly under the Central Government in which the enterprise is located,and approved by the administrative department of health of the sameprovince, autonomous region or municipality, which will issue aPharmaceuticals Producer Licence. The administrative authorities forindustry and commerce shall not issue business licences to any enterprisesproducing pharmaceuticals without the Pharmaceutical Producer Licence.The Pharmaceutical Producer Licence shall have a period of validity, uponexpiration of which a new licence shall be issued after an examination forits renewal. Detailed measures for the renewal of such licences shall bestipulated by the administrative department of health under the StateCouncil.Article 5To establish a pharmaceutical producing enterprise, the followingrequirements must be met:(1) It shall be staffed with the necessary personnel required forproducing the medicines concerned, that is, pharmacists or technicalpersonnel with a qualification equivalent to or higher than assistantengineer as well as skilled workers. If an enterprise processing Chinesetraditional medicines into ready-to-use mixture and powder forms does nothave pharmacists or technical personnel with a qualification equivalent toor higher than assistant engineer, it shall be staffed instead withskilled pharmaceutical workers who are familiar with the properties of themedicines processed and are registered with the administrative departmentof health at or above the county level.(2) It shall have factory premises, facilities and a sanitary environmentsuitable for the medicines produced.(3) It shall have a unit or competent personnel capable of inspecting thequality of the medicines produced, as well as necessary instruments andequipment.Article 6Pharmaceuticals must be produced in accordance with the technologicalprocedure, and the record of production must be complete and accurate.The process for preparing traditional Chinese medicines in ready-to-useforms must conform to the Pharmacopoeia of the People's Republic of Chinaor the Processing Norms stipulated by the administrative departments ofhealth of the provinces, autonomous regions, or municipalities directlyunder the Central Government.Article 7The raw and supplementary materials used for the production ofpharmaceuticals and containers and packaging materials in direct contactwith pharmaceuticals must conform to the requirements for medicinal use.Article 8Pharmaceuticals must go through quality inspection before they leave thefactory; products which do not meet the standards shall not leave thefactory.Article 9Pharmaceutical producing enterprises must draw up and carry out rules andregulations and sanitary requirements for ensuring the quality ofpharmaceuticals in accordance with the Standards for Quality Control ofPharmaceutical Production stipulated by the administrative department ofhealth under the State Council.

Chapter III Administration of Pharmaceutical Trading EnterprisesArticle 10The establishment of a pharmaceutical trading enterprise must besanctioned by the local competent authorities for the production andtrading of pharmaceuticals and approved by the administrative departmentof health at or above the county level, which will issue a PharmaceuticalTrading Enterprise Licence. The administrative authorities for industryand commerce shall not issue business licences to any enterprises withoutthe Pharmaceutical Trading Enterprise Licence.The Pharmaceutical Trading Enterprise Licence shall have a period ofvalidity, upon expiration of which a new licence shall be issued after anexamination for its renewal. Detailed measures for the renewal of suchlicences shall be stipulated by the administrative department of healthunder the State Council.Article 11To establish a pharmaceutical trading enterprise, the followingrequirements must be met:(1) It shall be staffed with pharmaceutical technicians qualified for thehandling of the pharmaceuticals.If an enterprise trading in Chinese traditional medicines or an enterpriseconcurrently trading in medicines does not have pharmaceuticaltechnicians, it shall be staffed instead with pharmaceutical workers whoare familiar with the properties of the medicines it trades in and areregistered with the administrative department of health at or above thecounty level.(2) It shall have business premises, equipment, storage facilities and asanitary environment suitable for the pharmaceuticals in which it trades.Article 12The quality of pharmaceuticals must be inspected on purchasing.Pharmaceuticals that do not meet the required standards must not bepurchased.Article 13It is imperative, in the sale of pharmaceuticals, to be accurate and freeof mistakes, and to provide correct directions for use, dosage andprecautions. Prescriptions being dispensed must be checked.Pharmaceuticals listed in prescriptions must not be presumptuously changedor substituted. Prescriptions containing incompatible substances orexcessive dosages shall be rejected by the dispensary. If necessary, suchprescriptions can be dispensed after they have been corrected or resignedby the doctors who wrote them out.When famous traditional Chinese medicinal materials are offered for sale,their origin must be indicated.Article 14Rules for storage of pharmaceuticals shall be formulated and implementedby pharmaceutical warehouses, which must adopt necessary measures tofacilitate cold storage and protection against moisture, insects androdents.An inspection system shall be carried out for pharmaceuticals entering orleaving warehouses.Article 15Unless otherwise stipulated by the state, traditional Chinese medicinalmaterials may be marketed at urban or rural fairs.Pharmaceuticals other than traditional Chinese medicinal materials may notbe sold at urban or rural fairs, except by those who have PharmaceuticalsTrading Enterprise Licences.

Chapter IV Administration of Pharmaceuticals at Medical UnitsArticle 16Medical units must be staffed with pharmaceutical technical personnelcommensurate with their medical functions. Non-pharmaceutical technicalpersonnel may not engage directly in pharmaceutical technical work.Article 17To make medicinal preparations, a medical unit must be examined, approvedand issued a Dispensing Permit by the administrative department of healthof the province, autonomous region, or municipality directly under theCentral Government in which the units is located.The Dispensing Permit shall have a period of validity, upon expiration ofwhich a new permit shall be issued after an examination for its renewal.Detailed measures for the renewal of such permits shall be stipulated bythe administrative department of health under the State Council.Article 18Medical units making medicinal preparations must be equipped withfacilities, inspection instruments and sanitary conditions capable ofensuring the quality of the preparations.Article 19The quality of the medicinal preparations made by medical units must beinspected in accordance with relevant regulations and clinical needs.Those up to standard can be used as the doctor prescribes.Medicinal preparations made by medical units may not be sold on themarket.Article 20Medical units must implement a system of quality inspection whenpurchasing pharmaceuticals.

Chapter V Pharmaceutical AdministrationArticle 21The state encourages research on and development of new medicines.When working on a new medicine, it is necessary to submit, as required,the methods of production, quality indices, pharmacological andtoxicological testing results, and other related materials and samples tothe administrative department of health under the State Council or to theadministrative department of health of the relevant province, autonomousregion, or municipality directly under the Central Government. Clinicaltests or clinical verifications can be carried out only after approval.A new medicine which has completed its clinical tests or clinicalverifications and been approved after appraisal shall be issued acertificate by the administrative department of health under the StateCouncil.Article 22A new medicine can be put into production only after the administrativedepartment of health under the State Council has approved it and issued aregistered document of approval. However, this does not apply to theproduction of traditional Chinese medicines prepared in ready-to-useforms.A medicine standardized by the state or by a province, an autonomousregion, or a municipality directly under the Central Government shall beput into production only after the administrative department of health ofthe relevant province, autonomous region, or municipality directly underthe Central Government has made an examination of the medicine, given itapproval and issued a registered document of approval, seeking beforehandthe opinions of the authorities at the same level in charge of theproduction and trading of medicines. However, this does not apply to theproduction of traditional Chinese medicines prepared in ready-to-useforms.Article 23Pharmaceuticals must meet the pharmaceutical standards of the state orthose of the relevant province, autonomous region, or municipalitydirectly under the Central Government.The Pharmacopoeia of the People's Republic of China and the pharmaceuticalstandards promulgated by the administrative department of health under theState Council shall be the state pharmaceutical standards.The Pharmacopoeia Committee of the administrative department of healthunder the State Council shall be responsible for organizing theformulation and revision of the state pharmaceutical standards.Article 24The administrative department of health under the State Council andadministrative departments of health of provinces, autonomous regions, andmunicipalities directly under the Central Government may establishpharmaceutical examination and evaluation committees to carry outexamination and evaluation of new medicines and to reevaluate medicinesalready put into production.Article 25The administrative department of health under the State Council shallorganize investigations of medicines which have been approved forproduction. It shall revoke the registered documents of approval if itdiscovers that the medicines' curative effects are uncertain or poor, orthat they produce serious adverse reactions or for other reasons areharmful to people's health.Production and sale of medicines whose registered documents of approvalhave been revoked shall not be allowed to continue; those which havealready been produced shall be destroyed or disposed of under thesupervision of the local administrative department of health.Article 26Import of medicines whose curative effects are uncertain or poor, or whichproduce adverse reactions or have other harmful effects on people's healthshall be prohibited.Article 27For any medicine which is to be imported for the first time, the importermust submit the manuals, quality standards, methods of inspection andother related information and samples, as well as the exporting country's(region's) certification documents approving its production, to theadministrative department of health under the State Council, and importcontracts may be signed only with the prior approval of the saiddepartment.Article 28Imported medicines must be inspected by the pharmaceutical inspectioninstitutions authorized by the administrative department of public healthunder the State Council; those having passed the inspection shall beallowed to be imported. Medicines to be imported in small quantities forurgent clinical needs by medical units or for personal use shall behandled according to customs regulations.Article 29The administrative department of health under the State Council shall havethe power to restrict or prohibit the export of traditional Chinesemedicinal materials and prepared Chinese medicines which are in shortsupply in the domestic market.Article 30Import Licences or Export Licences issued by the administrative departmentof health under the State Council are required for the import or export ofnarcotics and psychotropic substances falling within the restricted scopeprescribed by the administrative department of health under the StateCouncil.Article 31Newly discovered domestic medicinal plants or medicinal plants introducedfrom abroad may be sold only after they have been examined and approved bythe administrative department of health of the relevant province,autonomous region, or municipality directly under the Central Government.Article 32Measures for controlling medicinal materials traditionally used by localpeople in certain regions shall be formulated by the administrativedepartment of health under the State Council.Article 33The production and sale of fake medicines are prohibited. A fake medicinehas either of the following characteristics:(1) the names of its components are different from those prescribed for itby state pharmaceutical standards or pharmaceutical standards of therelevant province, autonomous region, or municipality directly under theCentral Government;(2) a non-medical substance is passed off as a medicine, or one medicineis passed off as another.A medicine shall be handled as fake medicine in any of the followingcases:(1) where the use of the medicine has been prohibited by theadministrative department of health under the State Council;(2) where the medicine has been produced without being assigned aregistration number;(3) where the medicine has deteriorated and cannot be used as such; or(4) where the medicine has been contaminated and cannot be used as such.Article 34The production and sale of medicines of inferior quality shall beprohibited. A medicine of inferior quality has any of the followingcharacteristics:(1) the components of the medicine do not conform in quantity to thatrequired by state pharmaceutical standards or pharmaceutical standards ofthe relevant province, autonomous region, or municipality directly underthe Central Government;(2) the medicine has passed its expiry date; or(3) the medicine fails to meet the prescribed standards in other respects.Article 35Personnel in pharmaceutical producing or trading enterprises and inmedical units who have direct contact with medicines must undergo anannual medical examination. Persons who have contracted contagiousdiseases or any other disease which may contaminate the medicines shallnot be allowed to engage in any work which has direct contact withpharmaceuticals.

Chapter VI Packaging and Repackaging of PharmaceuticalsArticle 36Packaging must meet the specific quality requirements of thepharmaceuticals and facilitate their storage, transportation and medicaluse. If a medicine has a period of validity, it must be clearly indicatedon the package.Traditional Chinese medicinal materials must be packaged beforetransportation. There must appear on the package the name of the medicine,place of production, date, name of the consignor, and an indication thatthe quality of the medicine is up to standard.Article 37Packages of pharmaceuticals must, in accordance with the regulations, belabeled and include directions for use.The label or directions must indicate the name of the medicine,specifications, the producer, registration number, batch number of theproduct, principal components, indications, directions for use dosage,contraindications, adverse reactions and precautions.Special indications must be printed as required on the labels ofnarcotics, psychotropic substances, toxic drugs, radioactive drugs andmedicines for external use.Article 38A pharmaceuticals trading enterprise engaged in the repackaging ofmedicines must possess the necessary facilities and sanitary conditionssuitable for the purpose, and pharmaceutical technicians must be placed incharge of this work. The repackaging records must be complete andaccurate.The repackaged medicine must enclose directions for use, and on thepackage must be indicated the name of the medicine, specifications, theproducer, the batch number of the product, the repackaging unit and thelot number of the repackaged product. If the medicine has a period ofvalidity, it must also be indicated on the new package.

Chapter VII Pharmaceuticals Under Special ControlArticle 39The state adopts special measures for the control of narcotics,psychotropic substances, toxic drugs and radioactive drugs. Regulationsfor the control of these drugs shall be formulated by the State Council.Article 40Narcotics, including their mother plants, must be produced only by unitsjointly designated by the administrative department of health under theState Council and other departments concerned, and must be supplied byunits jointly designated by the administrative department of health ofprovinces, autonomous regions, and municipalities directly under theCentral Government and other departments concerned.

Chapter VIII Administration of Trademarks and Advertisements of PharmaceuticalsArticle 41Registered trademarks must be used for all pharmaceuticals with theexception of traditional Chinese medicinal materials and theirpreparations in ready-to-use forms. The sale of pharmaceuticals withoutcompleting trademark registration shall be prohibited.The registered trademark must appear on the package and the label of themedicine.Article 42Advertisements of pharmaceuticals must be examined and approved by theadministrative department of health of the relevant province, autonomousregion, or municipality directly under the Central Government. In theabsence of such approval, advertisement of any medicine may not bepublished, broadcast, handed out or posted on walls.Article 43Foreign enterprises which apply to advertise pharmaceuticals in China mustsubmit relevant documents of approval by the country (region) in which thepharmaceuticals are produced, directions for use and other relevantmaterials.Article 44Advertisements of pharmaceuticals must be based on the directions for useapproved by the administrative department of health under the StateCouncil or the administrative departments of health of provinces,autonomous regions, or municipalities directly under the CentralGovernment.

Chapter IX Supervision over PharmaceuticalsArticle 45The administrative departments of health at or above the county levelshall exercise supervisory power over pharmaceuticals.The administrative departments of health at or above the county level mayset up organs for the administration of pharmaceuticals and organs for theinspection of pharmaceuticals.Article 46There shall be pharmaceutical inspectors in the administrative departmentsof health at or above the county level. Pharmaceutical inspectors shall beappointed from among pharmacological technical personnel and issuedcertificates by the people's governments at the same level.Article 47Pharmaceutical inspectors are authorized to exercise, in accordance withthe regulations, supervision, inspection and sampling as regards thequality of pharmaceuticals in the producing enterprises, tradingenterprises and medical units within their jurisdiction, and whennecessary may pick samples at random and ask for relevant data inaccordance with regulations. The enterprises and units concerned may notrefuse such requests or withhold relevant data. Pharmaceutical inspectorsare duty-bound to keep confidential the technical information provided bypharmaceutical producing enterprises and scientific research institutions.Article 48Pharmaceutical producing enterprises, pharmaceutical trading enterprisesand medical institutions shall conduct regular surveys of the quality,curative effects and adverse reactions of the pharmaceuticals they haveproduced, traded in or used. When drug poisoning is discovered, themedical institution concerned must promptly report the matter to the localadministrative department of health.Article 49The organs or personnel in charge of pharmaceutical inspection inpharmaceutical producing enterprises and pharmaceutical tradingenterprises shall receive operational guidance from the localpharmaceutical inspection organs.

Chapter X Legal ResponsibilityArticle 50Whoever produces or sells fake medicines shall have his fake medicines andunlawful income confiscated and may concurrently be fined; in addition, hemay be ordered to suspend production or business operations pendingrectification, or have his Pharmaceutical Producer Licence, PharmaceuticalTrading Enterprise Licence or Dispensing Permit revoked.An individual who produces or sells fake medicines, or the person directlyresponsible for a unit which commits this offence, and thereby endangerspeople's health, shall be investigated for criminal liability underArticle 164 of the Criminal Law.Article 51Whoever produces or sells medicines of inferior quality shall have hismedicines of inferior quality and unlawful income confiscated and may befined as well. If the circumstances are serious, the unit concerned shallbe ordered to suspend production or business operations pendingrectification, or have its Pharmaceutical Producer Licence, PharmaceuticalTrading Enterprise Licence or Dispensing Permit revoked. An individualwho produces or sells medicines of inferior quality or the person directlyresponsible for a unit which commits this offence, and thereby endangerspeople's health and causes serious consequences, shall be investigated forcriminal liability in reference to the provisions of Article 164 of theCriminal Law.Article 52Any unit engaged in the production, trading or preparation of medicineswithout obtaining the Pharmaceutical Producer Licence, PharmaceuticalTrading Enterprise Licence or Dispensing Permit shall be ordered tosuspend production, business operations or preparation of such medicines.The medicines and unlawful income shall all be confiscated and a fine mayalso be imposed.Article 53Whoever violates any other provision of this Law on the administration ofpharmaceutical production and pharmaceutical trading shall be served awarning or be fined.Article 54The decision to mete out administrative sanctions stipulated in this Lawshall be made by the administrative departments of health at or above thecounty level. The decision to mete out administrative sanctions forviolations of the provisions of Article 15 or of Chapter VIII onadministration of advertisements of this Law shall be made by theadministrative departments for industry and commerce.Punishment by suspension of production or business operations pendingrectification for seven days or more, or revocation of the PharmaceuticalProducer Licence or Pharmaceutical Trading Enterprise Licence to be metedout to pharmaceutical producing enterprises or pharmaceutical tradingenterprises directly under the jurisdiction of the Central Government orof the people's governments of provinces, autonomous regions, ormunicipalities directly under the Central Government, shall be submittedby the administrative department of health of the relevant province,autonomous region, or municipality directly under the Central Governmentto the people's government at the same level for final decision.Punishment by suspension of production or business operations for sevendays or more, or revocation of the Pharmaceutical Producer Licence orPharmaceutical Trading Enterprise Licence, to be meted out topharmaceutical producing enterprises or pharmaceutical trading enterprisesunder the jurisdiction of people's governments at or below the city orcounty level, shall be submitted by the administrative department ofhealth of the people's governments at or below the city or county level tothe people's governments at the same level for final decision. Theconfiscated pharmaceuticals shall be disposed of under the supervision ofthe administrative departments of health.Article 55If the party concerned does not accept the administrative sanction decidedon, it may file suit in the people's court within 15 days after receivingnotification of the sanction. However, the said party must immediatelycarry out the decision on the control of pharmaceuticals made by theadministrative department of health. If the party neither complies withthe sanction nor files suit within the time limit, the organ which madethe decision on the administrative sanction shall apply to the people'scourt for compulsory execution.Article 56If any individual or unit, in violation of this Law, causes drugpoisoning, he or it shall be liable for the damage. The victims mayrequest the administrative department of health at or above the countylevel to handle the matter; if a party does not accept the decision, itmay file suit in the people's court. The victims, too, may directly takethe case to the people's court.The claim for compensation must be made within a year from the day onwhich the victim or his representative was aware or should have been awareof the damage done. No claim for compensation shall be entertained beyondthe time limit.

Chapter XI Supplementary ProvisionsArticle 57For the purpose of this Law, the definitions of the following terms are:"Pharmaceuticals" means articles intended for use in the prevention,treatment or diagnosis of human diseases, or intended to effect thepurposive regulation of human physiological functions, for whichindications, usage and dosage are prescribed, including raw traditionalChinese medicinal materials, traditional medicines prepared in ready-to-use forms and other prepared Chinese medicines, medicinal chemicals andtheir preparations, antibiotics, biochemical medicines, radioactive drugs,serums, vaccines, blood products, diagnostic aids, etc."New medicines" means medicines which have not been produced in thiscountry before. "Supplementary materials" means the excipients andadditives used for the production and dispensing of pharmaceuticals."Pharmaceutical producing enterprise" means an enterprise exclusively orpartly engaged in the production of pharmaceuticals."Pharmaceutical trading enterprise" means an enterprise exclusively orpartly engaged in the trading of pharmaceuticals.Article 58The production of pharmaceuticals referred to in this Law does not includethe cultivation, collection and breeding of all categories of medicinalmaterials used in traditional Chinese medicine.Article 59The administrative department of health under the State Council shall,pursuant to this Law, draw up measures for its implementation, which shallenter into force after being submitted to and approved by the StateCouncil.Measures for the control of pharmaceuticals specially needed by theChinese People's Army shall be formulated by the competent militarydepartment of the state.Article 60This Law shall enter into force as of July 1, 1985.