Drug Control Law of the People’s Republic of China
(Adopted at the 7th Meeting of the Standing Committee of the Sixth National People’s Congress on September 20, 1984;
revised at the 20th Meeting of the Standing Committee of the Ninth National People’s Congress on February 28, 2001 and promulgated
by Order No.45 of the President of the People’s Republic of China on February 28, 2001)
Contents
Chapter I General Provisions
Chapter II Control over Drug Manufacturers
Chapter III Control over Drug Distributors
Chapter IV Control over Pharmaceuticals in Medical Institutions
Chapter V Control over Drugs
Chapter VI Control over Drug Packaging
Chapter VII Control over Drug Pricing and Advertising
Chapter VIII Inspection of Drugs
Chapter IX Legal Liabilities
Chapter X Supplementary Provisions
Chapter I
General Provisions
Article 1 This Law is enacted to tighten drug control, to ensure drug quality and safety for human beings, to protect the health
of people and their legitimate rights and interests in the use of drugs.
Article 2 All institutions and individuals engaged in research, production, distribution, use, or control over drugs in the People’s
Republic of China shall abide by this Law.
Article 3 The State develops both modern and traditional medicines to give full play to their role in prevention and treatment of
diseases and in maintenance of health.
The State protects the resources of natural crude drugs and encourages the cultivation of Chinese crude drugs.
Article 4 The State encourages research and development of new drugs and protects the legitimate rights and interests of citizens,
legal bodies and other institutions engaged in this field of endeavor.
Article 5 The drug regulatory department under the State Council shall be responsible for drug regulation nationwide. The relevant
departments under the State Council shall be responsible for the related regulatory work within the limits of their duties.
The drug regulatory departments of the people’s governments of provinces, autonomous regions, and municipalities directly under the
Central Government shall be responsible for drug regulation in their administrative areas. The relevant departments of the said people’s
governments shall be responsible for the related regulatory work within the limits of their duties.
The drug regulatory department under the State Council shall cooperate with the competent department for comprehensive economic administration
under the State Council in implementing pharmaceutical development programs and policies formulated by the State for the pharmaceutical
industry.
Article 6 The drug testing institutes established or designated by drug regulatory departments shall undertake the responsibility
for drug testing required for conducting drug examination, granting approval and controlling drug quality in accordance with law.
Chapter II
Control over Drug Manufacturers
Article 7 The establishment of a drug manufacturer shall be subject to approval by the local drug regulatory department of the people’s
government of the province, autonomous region or municipality directly under the Central Government and be granted the Drug Manufacturing
Certificate, and, with the certificate, the manufacturer shall be registered with the administrative department for industry and
commerce. No one may manufacture drugs without the certificate.
The valid term and the scope of manufacturing shall be indicated in the Drug Manufacturing Certificate. For renewal of the certificate
on expiration, reexamination is required.
When giving approval to the establishment of a new manufacturer, the drug regulatory department shall see to it that, apart from
the requirements specified by the provisions in Article 8 of this Law that should be met, the pharmaceutical development programs
and policies formulated by the State for the pharmaceutical industry are conformed to and prevent duplicate construction.
Article 8 A drug manufacturer to be established shall meet the following requirements:
(1)having legally qualified pharmaceutical and engineering professionals, and the necessary technical workers;
(2)having the premises, facilities, and hygienic environment required for drug manufacturing;
(3)having the institutions and personnel capable of quality control and testing for drugs to be produced and the necessary instruments
and equipment; and
(4)having rules and regulations to ensure the quality of drugs.
Article 9 Drug manufacturers shall conduct production according to the Good Manufacturing Practice for Pharmaceutical Products (GMP)
formulated by the drug regulatory department under the State Council on the basis of this Law. The drug regulatory department shall
inspect a drug manufacturer as to its compliance with the GMP requirements and issue a certificate to the manufacturer passing the
inspection.
The specific measures and schedule for implementing the GMP shall be formulated by the drug regulatory department under the State
Council.
Article 10 With the exception of the processing of prepared slices of Chinese crude drugs, a drug shall be produced in conformity
with the National Drug Standard and with the production processes approved by the drug regulatory department under the State Council,
and the production records shall be complete and accurate. When drug manufacturers make any change in the production process that
may affect the drug quality, they shall submit the matter for examination and approval to the original approval authority.
Prepared slices of Chinese crude drugs shall be processes in conformity with the national drug standards. Those not covered by the
national drug standards shall be produced according to 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. The said processing
procedures shall be submitted to the drug regulatory department under the State Council for the record.
Article 11 The drug substances and excipients for the manufacture of pharmaceutical products shall meet the requirements for medicinal
use.
Article 12 Drug manufacturers shall perform quality test of the drugs produced; no drugs that do not meet the national drug standards
or that are not produced according to the processing procedures for the prepared slices of Chinese crude drugs formulated by the
drug regulatory department of the people’s government of the province, autonomous region, or municipality directly under the Central
Government may be released.
Article 13 A drug manufacturer may accept contract production of drugs upon approval by the drug regulatory department under the
State Council, or by the drug regulatory department of the people’s government of a province, autonomous region, or municipality
directly under the Central Government authorized by the drug regulatory department under the State Council.
Chapter III
Control over Drug Distributors
Article 14 The establishment of a drug wholesaler shall be subject to approval of the local drug regulatory department of the people’s
government of the province, autonomous region or municipality directly under the Central Government and be granted the Drug Distribution
Certificate; the establishment of a drug retailer shall be subject to approval and be granted the said certificate by the local drug
regulatory department at or above the county level. With the certificate, the wholesaler and the retailer shall be registered with
the administrative department for industry and commerce. No one may distribute drugs without the certificate.
The valid term and the scope of business shall be indicated in the Drug Distribution Certificate. For renewal of the certificate
upon expiration, reexamination is required.
When giving approval to the establishment of a new distributor, the drug regulatory department shall see to it that, apart from the
requirements specified by the provisions in Article 15 of this Law that should be met, the principles of appropriate location and
convenient purchase of drugs by the people are adhered to.
Article 15 A drug distributor to be established shall meet the following requirements:
(1) having legally qualified pharmaceutical professionals;
(2)having the business operation premises, equipment, warehouses and hygienic environment required for drug distribution;
(3)having the units or personnel for quality control over the drugs to be distributed; and
(4) having rules and regulations to ensure the quality of the drugs to be distributed.
Article 16 Drug distributors shall conduct business according to the Good Supply Practice for Pharmaceutical Products (GSP) formulated
by the drug regulatory department under the State Council on the basis of this Law. The drug regulatory department shall inspect
a drug distributor as to its compliance with the GSP requirements, and issue a certificate to the distributor passing the inspection.
The specific measures and schedule for implementing the GSP shall be formulated by the drug regulatory department under the State
Council.
Article 17 For purchasing drugs, drug distributors shall establish and apply a system for quality inspection and acceptance, and
check the certificate of drug quality, labels and other marks; no drugs that do not meet the requirements may be purchased.
Article 18 Drug distributors shall keep authentic and complete records when purchasing and selling drugs. In the record shall be
indicated the adopted name in China, dosage form, strength or size, batch number, date of expiry, manufacturer, purchase (or sale)
unit, amount of the drug purchased (or sold), purchase or sale price, date of purchase (or sale), and other items specified by the
drug regulatory department under the State Council.
Article 19 Drug distributors shall sell drugs properly and make correct description of usage, dosage and cautions; prescription for
dispensing shall be checked, and no drugs listed in the prescription may be changed or substituted without authorization. They shall
refuse to dispense incompatible or over-dose prescriptions; when necessary, they may do the dispensing only after corrections or
re-signing is made by the prescribing physician.
Drug distributors shall indicate the origin of the Chinese crude drugs to be sold.
Article 20 A drug distributor shall establish and practise a system for drug storage, and take necessary measures to ensure drug
quality, such as cold storage, protection against freeze and humidity and avoidance of insects and rodents.
An examination system shall be applied for placing drugs in and releasing them from storage.
Article 21 Chinese crude drugs may be sold at town and country fairs, except those otherwise specified by the State Council.
No drugs other than the Chinese crude drugs may be sold at town and country fairs, but drug retailers holding the Drug Distribution
Certificate may, within the specified business scope, sell such drugs at stores they set up at the fairs. Specific measures shall
be formulated by the State Council.
Chapter IV
Control over Pharmaceuticals in Medical Institutions
Article 22 A medical institution shall be staffed with legally qualified pharmaceutical professionals. No one who is not a pharmaceutical
professional may directly engage in technical work in pharmacy.
Article 23 To dispense pharmaceutical preparations, a medical institution shall be subject to examination and permission by the administrative
department for health of the people’s government of the province, autonomous region or municipality directly under the Central Government,
and upon approval by the drug regulatory department of the said people’s government, a Pharmaceutical Preparation Certificate for
Medical Institution shall be issued to it by the said drug regulatory department. No one may dispense pharmaceutical preparations
without such certificate.
The valid term shall be indicated in the certificate. For renewal of the certificate upon expiration, reexamination is required.
Article 24 To dispense pharmaceutical preparations, the medical institution shall possess the facilities, management system, testing
instruments and hygienic conditions for ensuring their quality.
Article 25 The pharmaceutical preparations to be dispensed by the medical institution shall be ones that are to meet the clinic need
of the institution but are not available on the market and shall be subject to approval in advance by the local drug regulatory department
of the people’s government of the province, autonomous region or municipality directly under the Central Government. The quality
of the dispensed pharmaceutical preparations shall be subject to test according to regulations; those passing the testing may be
used within the institution on the basis of the physician’s prescription. In special cases, the pharmaceutical preparations dispensed
by a medical institution may be used by other designated medical institutions, upon approval by the drug regulatory department under
the State Council or by the drug regulatory department of the people’s government of a province, autonomous region or municipality
directly under the Central Government.
No pharmaceutical preparations dispensed by medical institutions may be marketed.
Article 26 For purchasing drugs, medical institutions shall establish and practise a system for quality inspection and acceptance,
and check the certificate of drug quality, labels and other marks; no drugs that do not meet the specified requirements may be purchased
or used.
Article 27. Prescriptions dispensed by pharmacists of medical institutions shall be checked, and no drugs listed in the prescriptions
may be changed or substituted without authorization. The pharmacists shall refuse to dispense incompatible or over-dose prescriptions;
when necessary, they may do the dispensing only after corrections or re-signing is made by the prescribing physician.
Article 28 A medical institution shall establish and practise a system for drug storage, and take necessary measures to ensure drug
quality, such as cold storage, protection against freeze and humidity and avoidance of insects and rodents.
Chapter V
Control over Drugs
Article 29 The dossier on a new drug research and development including the manufacturing process, quality specifications, results
of pharmacological and toxicological tests, and the related data and the samples shall, in accordance with the regulations of the
drug regulatory department under the State Council, be truthfully submitted to the said department for approval, before clinical
trial is conducted. Measures for verifying the qualifications of clinical study institutions for drugs shall be formulated jointly
by the drug regulatory department and the administrative department for health under the State Council.
When a new drug has gone through the clinical trial and passed the evaluation, a New Drug Certificate shall be issued upon approval
by the drug regulatory department under the State Council.
Article 30 The institutions for non-clinical safety evaluation and study and clinical study institutions shall respectively implement
the Good Laboratory Practice for Non-Clinical Laboratory Studies (GLP) and Good Clinical Practice (GCP).
The GLP and GCP shall be formulated by the department designated by the State Council.
Article 31 Production of a new drug or a drug admitted by national drug standards shall be subject to approval by the drug regulatory
department under the State Council, and a drug approval number shall be issued for it, with the exception of the Chinese crude drugs
and the prepared slices of Chinese crude drugs which where no control by approval number is exercised. The list of the Chinese crude
drugs and the prepared slices of the Chinese crude drugs to be controlled by the approval number shall be compiled by the drug regulatory
department under the State Council, in conjunction with the administrative department for traditional Chinese medicines under the
State Council.
A drug manufacturer may produce the drug only after an approval number is granted to it.
Article 32 Drugs shall meet the national drug standards. The provisions in the second paragraph of Article 10 of this Law shall be
applicable to the prepared slices of Chinese crude drugs.
The Pharmacopoeia of the People’s Republic of China and the drug standards issued by the drug regulatory department under the State
Council shall serve as the national drug standards.
The drug regulatory department under the State Council shall organize a pharmacopoeia commission, which shall be responsible for
formulating and revising the national drug standards.
The drug testing institution affiliated to the drug regulatory department under the State Council is responsible for defining the
national drug standard substance and reference substance.
Article 33 The drug regulatory department under the State Council shall organize experts in pharmaceutical, medical and other fields
to evaluate new drugs and re-evaluate the drugs already approved for production.
Article 34 Drug manufacturers, drug distributors and medical institutions shall purchase drugs from pharmaceutical enterprises, which
are qualified for production or distribution, with the exception of the Chinese crude drugs where no control by approval number is
exercised.
Article 35 The State exercises special control over narcotic drugs, psychotropic substances, medicinal toxic drugs and radioactive
pharmaceuticals. Measures for the control in this respect shall be formulated by the State Council.
Article 36 The State adopts a protection system for certain traditional Chinese medicines. The specific measures shall be formulated
by the State Council.
Article 37 The State adopts different systems for the control over prescription and non-prescription drugs. The specific measures
shall be formulated by the State Council.
Article 38 The import of drugs with uncertain therapeutic efficacy, serious adverse reaction, or other factors harmful to human health
is prohibited.
Article 39 Examination of drugs to be imported shall be organized by the drug regulatory department under the State Council. A drug
may be imported only upon approval granted after the fact that it conforms to the quality specifications and is safe and effective
is affirmed through examination, and an import drug license shall be issued.
As to small amounts of drugs to be imported for urgent clinical needs of medical institutions or for personal medication, formalities
for import shall be completed in accordance with the relevant regulations of the State.
Article 40 Drugs shall be imported via the ports where drug importation is permitted, and be registered by the drug importers with
the local drug regulatory departments for the record. The customs shall release the drugs on the basis of the Drug Import Note issued
by the said departments, and may not release those drugs for which no Drug Import Note is issued.
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 drugs to be imported according to the regulations of the drug regulatory department under the State Council, and
sampling fees shall be charged in accordance with the provisions of the second paragraph of Article 41 of this Law.
The ports where drugs may be imported shall be proposed by the drug regulatory department under the State Council together with the
General Customs Administration and submitted to the State Council for approval.
Article 41 The drug regulatory department under the State Council shall designate drug testing institutions to test the following
drugs before they are marketed or at the time they are imported; no drugs that fail to pass the testing may be marketed or imported:
(1)biological products specified by the drug regulatory department under the State Council;
(2)drugs to be marketed in China for the first time; and
(3) other drugs specified by the State Council.
The testing items to be charged for the drugs listed in the preceding paragraph and the rates shall be decided on and publicized
by the financial department together with the competent pricing department under the State Council. Measures for collecting fees
for testing shall be formulated and announced by the financial department together with the drug regulatory department under the
State Council.
Article 42 The drug regulatory department under the State Council shall organize investigations of the drugs to the production or
importation of which it has granted approval; it shall withdraw the approval number or Import Drug License issued to drugs with uncertain
therapeutic efficacy, serious adverse reaction, or other factors harmful to human health.
No drugs whose Approval Numbers or Import Drug Licenses have been withdrawn may be produced, distributed or used. Those already produced
or imported shall be destroyed or disposed of under the supervision of the local drug regulatory department.
Article 43 The State adopts a system for drug reserve.
When major disasters, epidemic situations or other emergencies occur in the country, the department specified by the State Council
may transfer drugs from the enterprises to meet the urgent needs.
Article 44 The State Council shall have the power to restrict or prohibit the exportation of the drugs which are in short supply
within the country.
Article 45 Anyone who wishes to import or export narcotic drugs and psychotropic substances that fall within the scope specified
by the State shall produce the Import License or Export License issued by the drug regulatory department under the State Council.
Article 46 The newly-discovered crude drugs or cultivated crude drugs introduced from abroad may be marketed only after examination
and approval by the drug regulatory department under the State Council.
Article 47 Measures for the control over the folk crude drugs customarily used in certain regions shall be formulated by the drug
regulatory department together with the administrative department for traditional Chinese medicines under the State Council.
Article 48 Production (including dispensing, the same below) and distribution of counterfeit drugs are prohibited.
A drug is a counterfeit drug in any of the following cases:
(1) the ingredients in the drug are different from those specified by the national drug standards; or
(2) a non-drug substance is simulated as a drug or one drug is simulated as another.
A drug shall be treated as a counterfeit drug in any of the following cases:
(1)its use is prohibited by the regulations of the drug regulatory department under the State Council;
(2)it is produced or imported without approval, or marketed without being tested, as required by this Law;
(3)it is deteriorated;
(4)it is contaminated;
(5)it is produced by using drug substances without approval number as required by this Law; or
(6)the indications or functions indicated are beyond the specified scope.
Article 49 Production and distribution of substandard drugs are prohibited.
A drug with content not up to the national drug standards is a substandard drug.
A drug shall be treated as a substandard drug in any of the following cases:
(1) the date of expiry is not indicated or is altered;
(2) the batch number is not indicated or is altered;
(3) it is beyond the date of expiry;
(4) no approval is obtained for the immediate packaging material or container;
(5) colorants, preservatives, spices, flavorings or other excipients are added without authorization; or
(6) other cases where the drug standards are not conformed.
Article 50 A drug name listed in the national drug standards is an adopted name in China. Such an adopted name may not be used as
a trademark.
Article 51 Employees of drug manufacturers, drug distributors and medical institutions who are in direct contact with drugs shall
undergo health checkup annually. No one who suffers from infectious diseases or any other diseases which may cause contamination
to drugs may engage in any work in direct contact with drugs.
Chapter VI
Control over the Packaging of Drugs
Article 52 Immediate packaging materials and containers shall meet the requirements for medicinal use and the standards for ensuring
human health and safety. They shall, along with the drugs, be subject to examination and approval by the drug regulatory department.
No drug manufacturers may use immediate packaging materials and containers for which no approval is obtained.
If the immediate packaging materials and containers are not up to standard, the drug regulatory department shall give orders stopping
the use of such materials and containers.
Article 53 Drug packaging shall conform to drug quality requirements and be convenient for storage, transportation and medical use.
Chinese crude drugs shall be packed for transportation. On each package shall be indicated the name of the drug, the origin of production,
the date of consignment and the name of the consignor, with a quality certification mark attached.
Article 54 A label shall be printed on or attached to the drug package together with an insert sheet, as required by regulations.
In the label or insert sheet shall be indicated the adopted name of the drug in China, its ingredients, strength, manufacturer, approval
number, product batch number, production date, date of expiry, indications or functions, usage, dosage, contraindications, adverse
drug reactions, and precautions.
Specified marks shall be printed in the label of narcotic drugs, psychotropic substances, toxic drugs for medical use, radioactive
pharmaceuticals, drugs for topical use, and non-prescription drugs.
Chapter VII
Control over Drug Pricing and Advertising
Article 55 For drugs the prices of which are fixed or guided by the government according to law, the competent pricing department
of the government shall, on the pricing principle stipulated in the Pricing Law of the People’s Republic of China and on the basis
of average social cost, supply and demand on the market, and public affordability, rationally fix and adjust the prices, in order
to ensure that price is commensurate with quality, eliminate excessively high price, and protect the legitimate interests of users.
Drug manufacturers, drug distributors and medical institutions shall implement prices fixed or guided by the government. No one may
raise prices in any manner without authorization.
Drug manufacturers shall provide the truthful manufacturing and operation cost to the competent pricing department of the government.
No one may refuse to or falsely or deceptively report the cost.
Article 56 For drugs the prices of which are adjustable with the market according to law, drug manufacturers, drug distributors and
medical institutions shall fix the prices on the principles of fairness, rationality，good faith and commensuration of price with
quality, in order to provide the users with drugs of reasonable prices.
When fixing and indicating retailing prices, drug manufacturers, drug distributors and medical institutions shall abide by the regulations
on control over drug prices formulated by the competent pricing department under the State Council. Usurious profits and fraud in
pricing that harms the users’ interests are prohibited.
Article 57 Drug manufacturers, drug distributors and medical institutions shall provide the actual buying and selling prices and
quantity of the drugs purchased and sold, and other related data to the competent pricing department of the government.
Article 58 Medical institutions shall provide the patients with a list of drug prices; and the medical institutions designated by
medical insurance provider shall truthfully publicize the prices of drugs in common use in compliance with the specified measures,
in order to ensure reasonable use of drugs. Specific measures shall be formulated by the administrative department for health under
the State Council.
Article 59 Drug manufacturers, drug distributors and medical institutions are prohibited from offering or accepting, in private,
off-the-book rake-offs or other benefits in the course of purchasing and selling drugs.
Drug manufacturers, drug distributors or their agents are prohibited from offering, under any pretences, money or things of value
or other benefits to leading members, drug purchasers, physicians, or other related persons of the medical institutions where their
drugs are used. Leading members of medical institutions, drug purchasers, physicians, or other related persons, on their part, are
prohibited from accepting, under any pretences, money or things of value or other benefits offered by drug manufacturers and drug
distributors or their agents.
Article 60 Drug advertisements shall 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 where the enterprise is located, an approval number of drug
advertisement shall be issued. No one may launch advertisements without the approval number.
Prescription drugs may be introduced in the medical or pharmaceutical professional publications jointly designated by the administrative
department for health and the drug regulatory department under the S
