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DRUG ADMINISTRATION 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)
Contents
Chapter I General Provisions
Article 1 This Law is enacted to strengthen drug administration,
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 drug administration 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 administration nationwide. The relevant
departments under the State Council shall be responsible for the related
administrative 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 departments 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 review and approval and controlling
drug quality in accordance with law.
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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 manufacturer
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 processed 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 regions, 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.
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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 Supply 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 country
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
Supply 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 requirement 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 an examination and acceptance system, 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 apply
a system for drug storage, and take necessary measures to ensure 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 Supply 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.
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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 the 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 institutions 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 apply an examination and acceptance system, 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 on 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 apply
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.
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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 study, 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 clinical trials 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, which 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 complied by the drug regulatory department under the State Council, in
conjunction with the administrative department for traditional Chinese medicine
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 medicine preparations. The specific measures shall be
formulated by the State Council.
Article 37 The State adopts a classification system for
prescription and non-prescription drugs. The specific measures shall be
formulated by the State Council.
Article 38 The importation of drugs with uncertain therapeutic
efficacy, serious adverse reaction, or other factors harmful to human health
is prohibited.
Article 39 Evaluation 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 need 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 institutions 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 Administration
of Customs 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 of fees 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 need.
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 standard are not conformed.
Article 50 A drug name listed in the national drug standard
is an adopted name in China. Such an adopted name may not be used as a trademark.
Article 51 Staff members 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.
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Chapter VI Control over Drug
Packaging
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
and the name of the consignor, with a quality certification mark attached.
Article 54 A label shall be printed or stuck on 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.
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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 in 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
matter without authorization.
Drug manufacturers shall provide the truthful manufacturing and operating
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 State Council, but their advertisements
may not be released by mass media or disseminated to the general public
by other means.
Article 61 The content of drug advertisements shall be
truthful and lawful, and the insert sheet approved by the drug regulatory
department under the State Council shall be taken as the basis, and no false
content may be contained in them.
No unscientific, categorical assertion or warranty of described function
may be contained in drug advertisements; no names or images of government
departments,, medical or pharmaceutical research institutions, academic
institutions, or experts, scholars, physicians and patients may be used
as evidence for drug advertising.
No-drug advertisements may not deal with drug promotion.
Article 62 Drug regulatory departments of the people’s
governments of provinces, autonomous regions or municipalities directly
under the Central Government shall inspect the drug advertisements approved
by them, and inform the advertisement regulatory authority of those advertisements
that violate this Law or the Advertisement Law of the People’s Republic
of China, and put forward suggestions for their handling, and the said authority
shall deal with such cases according to law.
Article 63 Where drug pricing and advertising are not governed
by the provisions of this Law, the provisions of the Pricing Law of the
People’s Republic of China and the Advertisement Law of the People’s Republic
of China shall be applicable.
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Chapter VIII Inspection of
Drugs
Article 64 Drug regulatory departments shall have the power
to supervise and inspect, according to law and administrative regulations,
matters related to drug research and development, which it has given approval,
to drug production and distribution, and to the use of drugs by medical
institutions. No institutions or individuals concerned may resist the supervision
and inspection or conceal any facts.
When people from drug regulatory departments conduct supervision and inspection,
they shall show their identification documents, and they shall keep confidential
the technical and business secrets of the persons under inspection which
they come to know in the course of supervision and inspection.
Article 65 Drug regulatory departments may conduct selective
testing of drug quality in light of the need of supervision and inspection.
Sampling for selective testing shall be carried out according to relevant
regulations, and no fees whatever may be charged for sampling or testing.
The necessary expenses shall be listed and covered in accordance with the
regulations of the State Council.
The drug regulatory department shall take administrative enforcement measures
to seal or seize the drugs and related materials that are proved to be potentially
harmful to human health and shall, within seven days, make an administrative
decision on the matter in question. Where it is necessary to test such drugs,
it shall, within 15 days from the date the testing report is issued, make
the administrative decision.
Article 66 The drug regulatory department under the State
Council and the drug regulatory departments of the people’s governments
of provinces, autonomous regions and municipalities directly under the Central
Government shall regularly announce the results of selective testing of
drug quality. Where the announcement is improper, it shall be corrected
within the scope in which the original announcement is made.
Article 67 Where the party has objection to the results
of testing conducted by the drug testing institution, it may, within seven
days from the date it receives the testing results, apply for re-testing
to the said drug testing institution, or to such an institution established
or designated by the drug regulatory department at the next higher level,
and it may also directly apply to the drug testing institution established
or designated by the drug regulatory department under the State Council.
The drug testing institution that accepts the application shall, within
the time limit specified by the drug regulatory department under the State
Council, draw a conclusion from the re-test.
Article 68 Drug regulatory departments shall, in accordance
with regulations and on the basis of the GMP and GSP, make follow-up inspections
on the certified drug manufacturers and distributors.
Article 69 With regard to the drugs produced according
to the provisions of this Law by drug manufacturers not located in the region,
no local people’s government or drug regulatory department may, by means
of demanding drug testing or approval, restrict or deny their access to
the region.
Article 70 No drug regulatory department, or drug
testing institution established by the department, or the institution specially
engaged in drug testing designated by the department may be involved in
production or distribution of drugs, or recommend drugs in its name or have
the supervisor for drug production or sale named after it .
No staff members of drug regulatory departments, of drug testing institutions
established by the departments or of institutions specially engaged in drug
testing designated by the departments may be involved in drug production
or distribution.
Article 71 The State applies a system of report on adverse
drug reaction. Drug manufacturers, drug distributors and medical institutions
shall make constant investigations into quality, therapeutic efficacy
and reactions of the drugs produced, distributed and used by them. When
serious adverse drug reactions possibly induced by drug use are discovered,
they shall, without delay, report the matter to the local drug regulatory
departments and administrative departments for health of the people’s governments
of provinces, autonomous regions and municipalities directly under the Central
Government. Specific measures shall be formulated by the drug regulatory
department under the State Council together with the administrative department
for health under the State Council.
With regard to drugs with confirmed serious adverse reactions, the drug
regulatory department under the State Council or the drug regulatory department
of the people’s government of province, autonomous region or municipality
directly under the Central Government may take urgent control measures to
suspend their production, distribution and use, and it shall, within five
days, arrange for assessment and, within 15 days from the date the conclusion
is drawn, make an administrative decision on how to deal with the case.
Article 72 Drug testing sections of the drug manufacturers,
drug distributors and medical institutions and their staff members shall
accept technical instructions given by drug testing institutions set up
by the local drug regulatory departments.
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Chapter IX Legal Liabilities
Article 73 Any drug manufacturer or distributor that, without
obtaining Drug Manufacturing Certificate, Drug Supply Certificate
or Pharmaceutical Preparation Certificate for Medical Institution,
manufactures or distributes drugs shall be banned, the drugs illegally produced
or sold and the illegal gains there from shall be confiscated, and they
shall also be fined not less than two times but not more than five times
the value of the drugs (including the drugs sold and not sold, the same
below). If a crime is constituted, criminal liabilities shall be investigated
in accordance with law.
Article 74 Where counterfeit drugs are produced or sold,
the drugs illegally produced or sold and the illegal gains shall be confiscated,
and a fine not less than two times but not more than five times the value
of the said drugs shall be imposed. The approval documents, if any, shall
be withdrawn and an order shall be given to suspend production or business
operation for rectification. If the circumstances are serious, the Drug
Manufacturing Certificate, Drug Supply Certificate or Pharmaceutical Preparation
Certificate for Medical Institution shall be revoked. If a crime is constituted,
criminal liabilities shall be investigated in accordance with law.
Article 75 Where substandard drugs are produced or sold,
the drugs illegally produced or sold and the illegal gains shall be confiscated,
and a fine not less than, but not more than three times, the value of the
said drugs shall also be imposed. If the circumstances are serious, an order
shall be given to suspend production or business operation for rectification,
or the drug approval documents shall be withdrawn and the Drug Manufacturing
Certificate, the Drug supply Certificate, or the Pharmaceutical Preparation
Certificate for Medical Institution shall be revoked. If a crime is constituted,
criminal liabilities shall be investigated in accordance with law.
Article 76 Where enterprises or other institutions are
engaged in production or sale of counterfeit or substandard drugs, if the
circumstances are serious, the persons directly in charge and the other
persons directly responsible shall be prohibited from engaging in the drug
production or distribution within 10 years.
The drug substances, excipients, packaging materials and manufacturing equipment
specially used for producing counterfeit or substandard drugs by any producer
shall be confiscated.
Article 77 Anyone who knows or should know that the drugs
are counterfeit or substandard drugs provides conveniences such as transportation,
keeping or storage of the drugs, all the earnings therefrom shall be confiscated,
and a fine not less than 50 per cent of, but not more than 3 times, the
amount of the illegal earnings shall also be imposed. If a crime is constituted,
criminal liabilities shall be investigated in accordance with law.
Article 78 The quality testing results provided by the
drug testing institution shall be contained in the penalty notification
regarding counterfeit and substandard drugs, except in cases specified in
the provisions of Subparagraphs (1), (2), (5) and (6) of the third paragraph
of Article 48 and the third paragraph of Article 49 of this Law.
Article 79 Any drug manufacturer, drug distributor, institution
for non-clinical safety study, or institution for drug clinical trial that
does not implement the GMP, GSP, GLP or GCP according to regulations shall
be given a disciplinary warning and shall be instructed to rectify within
a time limit. If it fails to do so, it shall be instructed to suspend production
or business operation or other work for rectification and shall also be
fined not less than RMB5,000 yuan but not more than RMB20,000 yuan. If the
circumstances are serious, the Drug Manufacturing Certificate, Drug Supply
Certificate or the qualifications of the institution for drug clinical trial
shall be annulled.
Article 80 Any drug manufacturer, drug distributor or medical
institution that, in violation of the provisions of Article 34 of this Law,
purchases drugs from the enterprises without Drug Manufacturing Certificate
or Drug Supply Certificate shall be instructed to rectify, the drugs illegally
purchased shall be confiscated, and it shall be fined not less than two
times but not more than five times the value of the drugs purchased; the
illegal gains, if any, shall be confiscated. If the circumstances are serious,
the Drug Manufacturing Certificate, Drug Distribution Certificate, or the
license for the medical institution shall be revoked.
Article 81 If any enterprise that imports drugs to which
import drug license has been granted fails to register, in accordance with
the provisions of this Law, for the record with the drug regulatory department
in the place where the port is located and drug importation is permitted,
it shall be given a disciplinary warning and be instructed to rectify within
a time limit; if it fails to do so, the import drug license shall be revoked.
Article 82 If anyone falsifies, alters, alters, trades
in, rents out or lends the certificates or drug approval documents, the
illegal gains shall be confiscated and a fine not less than, but not mort
than three times, the amount of the illegal gains shall be imposed; if there
are no illegal gains, a fine not less than RMB 20, 000 yuan but not more
than RMB 100,000 yuan shall be imposed. If the circumstances are serious,
the Drug Manufacturing Certificate, Drug Supply Certificate or Pharmaceutical
Preparation Certificate for Medical Institution of the party that sells,
rents out or lends it shall be revoked. If a crime is constituted, criminal
liabilities shall be investigated in accordance with law.
Article 83 If anyone, in violation of the provisions of
this Law, obtains the Drug Manufacturing Certificate, Drug Distribution
Certificate, Pharmaceutical Preparation Certificate for Medical Institution,
or drug approval documents by providing false certificates, documents and
data, or samples, or by other fraudulent means, the said certificates shall
be revoked and the documents shall be withdrawn, his applications for such
certificates or approval documents shall be rejected within five years,
and a fine not less than RMB 10, 000 yuan but more than RMB 30, 000 yuan
shall also be imposed.
Article 84 Any medical institution that sells its own dispensed
pharmaceutical preparations on the market shall be instructed to rectify,
the preparations for illegal sale shall be confiscated, and a fine not less
than, but not more than three times, the value of the said preparations
shall be imposed, and the illegal gains, if any, shall be confiscated.
Article 85 Any drug distributor that violates the provisions
of Article 18 and 19 of this Law shall be instructed to rectify and be given
a disciplinary warning. If the circumstances are serious, the Drug Supply
Certificate shall be revoked.
Article 86 Where the drugs with labels or marks are not
in conformity with the provisions of Article 54 of this Law, except for
those treated as counterfeit or substandard drugs, an instruction for rectification
and a disciplinary warning shall be given. If the circumstances are serious,
the approval documents for the drugs shall be withdrawn.
Article 87 Where a drug testing institution issues a false
testing report, if it constitutes a crime, criminal liabilities shall be
investigated in accordance with law; if it does not constitute a crime,
the institution shall be instructed to rectify and be given a disciplinary
warning, and also be fined not less than RMB30, 000 yuan but not more than
RMB 50, 000 yuan. The persons directly in charge and the other person directly
responsible shall, in accordance with law, be punished with demotion, dismissal,
or expulsion and also be fined not more than RMB 30, 000 yuan. The illegal
gains, if any, shall be confiscated. If the circumstances are serious, the
qualification for testing shall be annulled. If the testing result issued
by the drug testing institution is not true to fact and losses are thus
occasioned, the institution shall bear corresponding liability of compensation
for losses.
Article 88 The administrative sanctions prescribed in Article
73 through Article 87 of this Law shall be determined by the drug regulatory
departments at or above the county level according to the division of responsibility
defined by the drug regulatory department under the State Council. Revocation
of the Drug Manufacturing Certificate, Drug Supply Certificate and Pharmaceutical
Preparation Certificate for Medical Institution or withdrawal of the drug
approval documents shall be determined by the department that issued the
certificate or the approval documents.
Article 89 Any violation of the provision of Article 55,
56 or 57 of this Law governing the control over drug pricing shall be punished
pursuant to the provisions of the Pricing Law of the People’s Republic of
China.
Article 90 Drug manufacturers, drug distributors or medical
institutions that offer or accept, in private, the rake-offs or other benefits
in the course of purchasing and selling drugs or drug manufacturers, drug
distributors or their agents that offer 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 shall be
fined not less than RMB 10, 000 yuan but not more than RMB 200, 000 yuan
by the administrative department for industry and commerce, and the illegal
gains, if any, shall be confiscated. If the circumstances are serious, the
said department shall revoke the business licenses of the drug manufacturers
or drug distributors and inform the drug regulatory department of the matter,
which shall revoke their Drug Manufacturing Certificate, or Drug Distribution
Certificate. If a crime is constituted, criminal liabilities shall be investigated
in accordance with law.
Article 91 Any leading members, purchasers or other related
persons of drug manufacturers or distributors that, in the course of drug
purchasing or selling, accept money or things of value or other benefits
offered by other manufacturers, distributors or their agents shall be given
sanctions according to law, and the illegal gains shall be confiscated.
If a crime is constituted, criminal liabilities shall be investigated in
accordance with law.
Leading members, drug purchasers, physicians or other related persons of
medical institutions who accept money or things of value or other benefits
offered by drug manufacturers, drug distributors or their agents shall be
given sanctions by the administrative department for health or the institutions
to which they belong, and the illegal gains shall be confiscated. With regard
to licensed physicians who seriously violate laws, the administrative department
for health shall revoke their licenses for medical practice. If a crime
is constituted, criminal liabilities shall be investigated in accordance
with law.
Article 92 Any violation of the provisions of this Law
related to the control over drug advertising shall be punished pursuant
to the provisions of the Advertisement Law of the People’s Republic of China,
the drug regulatory department that issues the advertisement approval number
shall withdraw it and shall, within one year, reject any application for
approval of advertising for the drug in question. If a crime is constituted,
criminal liabilities shall be investigated in accordance with law.
Where a drug regulatory department does not perform its duty of drug advertisement
examination in accordance with law and the advertisement approved for issuance
contains false information or other content violating laws or administrative
regulations, administrative sanctions shall, in accordance with law, be
given to the persons directly in charge and the other persons directly responsible.
If a crime is constituted, criminal liabilities shall be investigated in
accordance with law.
Article 93 Drug manufacturers, drug distributors or medical
institutions that violate the provisions of this Law and thus cause harm
and losses to users of drugs shall bear the liability of compensation in
accordance with law.
Article 94 Any drug regulatory department that violates
the provisions of this Law sand commits one of the following acts shall
be instructed by the competent authority at the next higher level or the
supervisory body to recall the certificates unlawfully issued or to withdraw
the drug approval documents, and administrative sanctions shall be given
to the persons directly in charge and the other persons directly responsible
in accordance with law. If a crime is constituted, criminal liabilities
shall be investigated in accordance with law.
(1) issuing the GMP and GSP certificates to the enterprises that do not
comply with the corresponding requirements, failing to perform, in accordance
with regulations, the duty of follow-up inspections in respect of the enterprises
that have obtained the certificates, or failing to instruct, in accordance
with law, the enterprises not complying with the requirements to rectify
or withdraw their certificates;
(2) issuing the Drug Manufacturing Certificate, Drug Supply Certificate
or Pharmaceutical Preparation Certificate for Medical Institution to the
enterprises or institutions that do not comply with the statutory requirements;
(3) issuing an Import Drug License to the drug that doest not comply with
the requirements for import; or
(5) granting approval for conducting a clinical trial, issuing a New Drug
Certificate or a drug approval number, where the requirements for clinical
trial or drug production are not fulfilled.
Article 95 If any drug regulatory department, drug testing
institution established by the department or institutions specially engaged
in drug testing designated by the department is involved in drug production
or distribution, it shall be instructed by the authority at the next high
level or the supervisory body to rectify, and the illegal gains, if any,
shall be confiscated. If the circumstances are serious, administrative sanctions
shall be givens to the persons directly in charge and the other persons
directly responsible in accordance with law. Any staff member of the drug
regulatory department, drug testing institution established by the department
or institution specially engaged in drug testing designated by the department
who is involved in drug production or distribution shall be given an administrative
sanction in accordance with law.
Article 96 If any drug regulatory department or drug testing
institution established or designated by the department, in violation of
law, collects testing fees for supervision over drug testing shall be instructed
by the relevant government department to return the fees, and administrative
sanctions shall be given to the persons directly in charge and the other
persons directly responsible in accordance with law. Any drug testing institution
that collects testing fees in violation of law, if the circumstances are
serious, shall be disqualified for drug testing.
Article 97 Drug regulatory departments shall, in accordance
with law, perform their duties of supervision and inspection and shall see
to it that the enterprises holding the Drug Manufacturing Certificate or
Drug Supply Certificate engage in drug production or drug distribution in
accordance with the provisions of this Law.
Where enterprises holding the Drug Manufacturing Certificate or Drug Supply
Certificate produce or sell counterfeit or substandard drugs, the legal
liabilities of such enterprises shall be investigated and, in addition,
the persons directly in charge and the other persons directly responsible
of the drug regulatory departments who neglect their duty or commit dereliction
of duty shall be given administrative sanctions in accordance with law.
If a crime is constituted, criminal liabilities shall be investigated in
accordance with law.
Article 98 The drug regulatory department shall instruct
the drug regulatory department at a lower level to put right, within a time
limit, the administrative action taken in violation of this Law, and it
shall have the power to alter or annual the action which is not put right
within the time limit.
Article 99 Anyone responsible for drug regulation who abuses
his power, engages in malpractice for personal gain or neglects his duty,
if it constitutes a crime, shall be investigated for criminal liabilities
in accordance with law; if it is not serious enough to constitute a crime,
he shall be given administrative sanctions in accordance with law.
Article 100 Where a Drug Manufacturing Certificate or Drug
Distribution Certificate is revoked in accordance with this Law, the drug
regulatory department shall notify the administrative department for industry
and commerce to alter or cancel the registration.
Article 101 The value of products mentioned in this Chapter
shall be calculated on the basis of the marked prices of the drugs illegally
produced or sold; where there is no marked price, the value shall be calculated
according to the market prices of drugs of the same kind.
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Chapter X Supplementary Provisions
Article 102 The terms used in this Law are defined as follows:
Drugs refer to articles which are used in the prevention, treatment and
diagnosis of human diseases and intended for the regulation of the physiological
functions of human beings, for which indications, usage and dosage are established,
including Chinese crude drugs, prepared slices of Chinese crude drugs, traditional
Chinese medicine preparations, chemical drugs substances and their preparations,
antibiotics, biochemical drugs, radioactive pharmaceuticals, serum, vaccines,
blood products and diagnostic agents.
Excipients refer to the vehicles and additives used for drug production
and prescription dispensing.
Drug manufacturers refer to enterprises exclusively or partly engaged in
drug production.
Drug distributors refer to enterprises exclusively or partly engaged in
drug distribution.
Article 103 Measures for control over the cultivation,
collection and breeding of Chinese crude drugs shall be separately formulated
by the State Council.
Article 104 The State exercises special control over the
circulation of preventive biological products. Specific measures shall be
formulated by the State Council.
Article 105 Specific measures for enforcement of this Law
by the Chinese People’s Liberation Army shall be formulated by the State
Council and Central Military Commission in accordance with this Law.
Article 106 This Law shall go into effect as of December
1, 2001.
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