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Law of the People's Republic of China on Pharmaceutical Administration
Promulgation Date : 2001-02-28
Effective Date : 2001-12-01
Promulgation Body : The Standing Committee of the National
People's Congress
Status : Effective
Chapter 1 General Principles
Article1
In order to strengthen the supervision over and administration
of pharmaceuticals, to guarantee the quality of pharmaceuticals,
to safeguard the security of pharmaceuticals for human bodies,
and to maintain the health and the legal rights and interests
of the masses to use and consume pharmaceuticals, this Law
is hereby enacted.
Article2
Units and individuals engaging in research, manufacture, management,
use, control, and supervision of pharmaceuticals in the territory
of the People's Republic of China must abide by this Law.
Article3
The state develops the modern and traditional pharmaceuticals
and exercises their function adequately on prevention, treatment,
and health care.
The state protects the wild pharmaceutical resources and
encourages cultivating Chinese traditional medical materials.
Article4
The state encourages researching and creating new pharmaceuticals,
and protects the legal rights and interests of citizens, legal
persons, and other organizations to research and create new
pharmaceuticals.
Article5
The supervisory and administrative departments in charge of
pharmaceuticals of the State Council shall be responsible
for the supervision over and administration of national pharmaceuticals.
The relevant departments of the State Council shall be responsible
for the supervision and administration work concerning pharmaceuticals
within their respective authorities.
The supervisory and administrative departments in charge
of pharmaceuticals of all provinces, autonomous regions, and
municipalities directly under the Central People's Government
shall be responsible for the supervision over and administration
of pharmaceuticals within their own administrative jurisdiction.
The relevant departments of all provinces, autonomous regions,
and municipalities directly under the Central People's Government
shall be responsible for the supervision and administration
work concerning pharmaceuticals within their respective authorities.
The supervisory and administrative departments in charge
of pharmaceuticals of the State Council shall cooperate with
the comprehensive administrations on economy of the State
Council to execute the development planning and industrial
polices on pharmaceutical industry as constituted by the state.
Article6
The supervisory and administrative departments in charge of
pharmaceuticals shall establish the pharmaceutical inspection
organs to implement the examination and approval on pharmaceuticals
according to law and the inspection on pharmaceuticals needed
by the inspection and supervision over quality of pharmaceuticals.
Chapter 2 Administration of Pharmaceutical Manufacturing Enterprises
Article7
Any unit or individual who wishes to establish pharmaceutical
manufacturing enterprises shall apply to the supervisory and
administrative departments in charge of pharmaceuticals of
all provinces, autonomous regions, and municipalities directly
under the Central People's Government for approval and the
Pharmaceutical Manufacture License. He shall then register
with the administration of industry and commerce with the
License. Without the Pharmaceutical Manufacture License, the
pharmaceuticals shall not be manufactured.
The validity period and manufacture scope shall be specified
in the Pharmaceutical Manufacture License. Upon expiry, it
shall be re-checked and re-issued.
Pharmaceutical manufacturing enterprises established upon
approval of the supervisory and administrative departments
in charge of pharmaceuticals shall not only be based on qualifications
as provided by Article 8 herein, but also accord with the
development planning and industrial policies on pharmaceuticals.
Duplicated construction shall be prevented.
Article8
Pharmaceutical manufacturing enterprises must possess the
following qualifications:
(1) Having pharmaceutical technicians, engineering technicians
and corresponding technical works with accredited qualifications;
(2) Having factory buildings, facilities, and healthy environment;
(3) Having organs, personnel, and equipment to control and
examine quality of produced pharmaceuticals; and
(4) Having regulations or rules to guarantee the quality
of pharmaceuticals.
Article9
Pharmaceutical manufacturing enterprises must organize production
according to the Administrative Criteria on Quality of Pharmaceuticals
formulated by the supervisory and administrative departments
in charge of pharmaceuticals of the State Council according
to this Law. The supervisory and administrative departments
in charge of pharmaceuticals shall authenticate whether pharmaceutical
manufacturing enterprise accord with this Criteria, and shall
issue the authentication certificate to qualified enterprises.
Detailed implementing measures and steps of these Criteria
shall be formulated by the supervisory and administrative
departments in charge of pharmaceuticals of the State Council.
Article10
Except processing of Chinese traditional medicine crude slices,
pharmaceuticals must be manufactured according to the manufacturing
technique approved by the supervisory and administrative departments
in charge of pharmaceuticals of the State Council and the
national pharmaceutical standard, and the manufacturing records
must be kept wholly. The pharmaceutical manufacturing enterprises,
if wishing to change manufacturing technique that will affect
quality of pharmaceuticals, shall report it to the original
approval department for examination and approval.
Chinese traditional medicine crude slices shall be processed
according to the national pharmaceutical standard. If the
state does not stipulate such standard, they shall be processed
according to the processing standard stipulated by the supervisory
and administrative departments in charge of pharmaceuticals
of all provinces, autonomous regions, and municipalities directly
under the Central People's Government. The processing standard
drafted by the supervisory and administrative departments
in charge of pharmaceuticals of all provinces, autonomous
regions, and municipalities directly under the Central People's
Government shall be reported to the supervisory and administrative
departments in charge of pharmaceuticals of the State Council
for records.
Article11
Raw materials and accessory materials for manufacturing pharmaceuticals
shall accord with the relevant criteria.
Article12
Pharmaceutical manufacturing enterprises must carry through
the quality examination on finished pharmaceuticals. Pharmaceuticals
that do not accord with the national pharmaceutical standard
or are not processed according to the processing criteria
formulated by The supervisory and administrative departments
in charge of pharmaceuticals of all provinces, autonomous
regions, and municipalities directly under the Central People's
Government shall not leave the manufacturing factory for selling.
Article13
Pharmaceutical manufacturing enterprises may be entrusted
to manufacture pharmaceuticals upon approval of the supervisory
and administrative departments in charge of pharmaceuticals
of the State Council or the supervisory and administrative
departments in charge of pharmaceuticals of all provinces,
autonomous regions, and municipalities directly under the
Central People's Government authorized by the former.
Chapter 3 Administration of Pharmaceutical Operation Enterprises
Article14
Any unit or individual who wishes to establish pharmaceutical
wholesale enterprises must apply to the supervisory and administrative
departments in charge of pharmaceuticals of all provinces,
autonomous regions, and municipalities directly under the
Central People's Government for issuing the Pharmaceutical
Operation License. Any unit or individual who wishes to establish
pharmaceutical retail enterprises must apply to the local
supervisory and administrative departments in charge of pharmaceuticals
for approval and the Pharmaceutical Operation License, and
then shall register with the local administration of industry
and commerce with the License. Without the License, anyone
shall not operate pharmaceuticals.
The validity period and manufacture scope shall be specified
in the Pharmaceutical Operation License. Upon expiry, it shall
be re-checked and re-issued.
Pharmaceutical operation enterprises established upon approval
of the supervisory and administrative departments in charge
of pharmaceuticals shall not only be based on qualifications
as provides by Article 15 herein, but also abide by the principle
of reasonable overall arrangement and being convenient for
the masses.
Article15
The pharmaceutical operation enterprises shall possess the
following qualifications:
(1) Having accredited pharmaceutical technicians;
(2) Having business places, equipment, warehousing facilities,
and sanitation corresponding to pharmaceutical operation;
(3) Having quality administration organs or personnel corresponding
to pharmaceutical operation; and
(4) Having regulations and rules to guarantee the quality
of pharmaceuticals.
Article16
The pharmaceutical operation enterprises shall operate pharmaceuticals
according to the Administrative Criteria on Quality of Pharmaceuticals
Operation formulated by the supervisory and administrative
departments in charge of pharmaceuticals of the State Council
according to this Law. The supervisory and administrative
departments in charge of pharmaceuticals shall authenticate
whether pharmaceutical operation enterprises accord with this
Criteria, and shall issue the authentication certificate to
qualified enterprises.
Detailed implementing measures and steps of these Criteria
shall be formulated by the supervisory and administrative
departments in charge of pharmaceuticals of the State Council.
Article17
The pharmaceutical operation enterprises shall establish the
system on examination, check, and acceptance on purchase when
purchasing pharmaceuticals, to verify the qualification certification
and other marks of pharmaceuticals, and shall not purchase
unqualified pharmaceuticals.
Article18
The pharmaceutical operation enterprises must have the true
and complete purchase and sale records. The purchase and sale
records must specify the general appellation of the pharmaceutical,
the medicament type, specification, approval number, validity
period, manufacturer, purchase or sale unit, quantity and
price of purchase or sale, date of purchase or sale, and other
contents as provided by the supervisory and administrative
departments in charge of pharmaceuticals of the State Council.
Article19
The pharmaceutical operation enterprises must sell pharmaceuticals
exactly, and shall correctly explain the usage, dosage, and
proceedings of attention. Preparation of prescription must
be verified; pharmaceuticals listed in the prescription shall
not be changed or substituted without authorization. The prescription
with surplus dosage or incompatibility drugs shall be refused
to prepare. When necessary, it may be prepared upon the second
signature of or correction of the prescription physician.
The places of origin of Chinese traditional materials sold
by pharmaceutical operation enterprises shall be indicated
clearly.
Article20
The pharmaceutical operation enterprises must formulate and
enforce the pharmaceutical safekeeping system, and adopt necessary
refrigeration, frostbite resistant, damp-proof, mothproof,
and mouse-proof measures to guarantee the quality of pharmaceuticals.
The strict examination system must be implemented for pharmaceuticals
to leave or enter the warehouse.
Article21
The Chinese traditional medicine materials may be sold on
the trading bazaars of cities and villages, unless it is provided
by the State Council otherwise.
Pharmaceuticals beyond the Chinese traditional medicine materials
shall not be sold on the trading bazaars of cities and villages.
However, the pharmaceutical retail enterprises with the Pharmaceutical
Operation License may sell pharmaceuticals beyond Chinese
traditional medicine materials on the trading bazaars of cities
and villages, within permitted range. The State Council shall
formulate the detailed measures.
Chapter 4 Administration of Medical Organizations on Medicament
Article22
The medical organizations must be equipped with pharmaceutical
technicians who are accredited according to law. Anyone who
is not the pharmaceutical technician shall not engage in the
technical pharmaceutical work directly.
Article23
The medical organizations, when compounding medicament, must
be examined and verified by the administrative departments
in charge of health of all provinces, autonomous regions,
and municipalities directly under the Central People's Government,
and apply to the supervisory and administrative departments
in charge of pharmaceuticals of all provinces, autonomous
regions, and municipalities directly under the Central People's
Government for approval and the Medicament License for Medical
Organizations. Without this License, the medicament shall
not be compounded.
The validity period must be indicated in this License. Upon
expiry, it shall be re-examined and re-issued.
Article24
When compounding medicament, the medical organizations must
have facilities, administrative rules, testing equipment,
and sanitary conditions to guarantee the quality of medicament.
Article25
The medicament compounded by medical organizations shall be
the variety that is needed by the clinic of their own units
and may not be purchased from the market, and shall be compounded
upon approval of the supervisory and administrative departments
in charge of pharmaceuticals of all provinces, autonomous
regions, and municipalities directly under the Central People's
Government. The quality examination must be carried through
for the compounded medicament. Qualified medicament may be
used in their own organizations by the prescription of the
physicians. The medicament of the medical organizations may
be regulated between appointed medical organizations upon
approval of the supervisory and administrative departments
in charge of pharmaceuticals of the State Council or all provinces,
autonomous regions, and municipalities directly under the
Central People's Government, under special conditions.
The medicament of the medical organizations shall not be
sold on the market.
Article26
The medical organizations shall establish the system on examination,
check, and acceptance on purchase when purchasing pharmaceuticals,
to verify the qualification certification and other marks
of pharmaceuticals, and shall not purchase unqualified pharmaceuticals.
The pharmaceutical operation enterprises must sell pharmaceuticals
exactly, and shall correctly explain the usage, dosage, and
proceedings of attention.
Article27
Preparation of prescription must be verified, pharmaceuticals
listed in the prescription shall not be changed or substituted
without authorization. The prescription with surplus dosage
or incompatibility drugs shall be refused to prepare. When
necessary, it may be prepared upon the second signature of
or correction of the prescription physician.
Article28
The medical organizations must formulate and enforce the pharmaceutical
safekeeping system, and adopt necessary refrigeration, frostbite
resistant, damp-proof, mothproof, and mouse-proof measures
to guarantee the quality of pharmaceuticals.
Chapter 5 Administration of Pharmaceuticals
Article29
The data and samples of research methods, quality index, results
of pharmacodynamics and virus experiments of newly researched
pharmaceuticals shall be reported to the supervisory and administrative
departments in charge of pharmaceuticals of the State Council
according to facts and the relevant provisions. Upon approval
of the supervisory and administrative departments in charge
of pharmaceuticals of the State Council, the new pharmaceutical
may be experimented for the clinic. The authentication measures
of the qualifications of the clinic experimental organs shall
be formulated by the supervisory and administrative departments
in charge of pharmaceuticals of the State Council and the
administrative departments in charge of health jointly.
The certificate shall be issued to new pharmaceuticals that
are qualified upon clinic experiment by the supervisory and
administrative departments in charge of pharmaceuticals of
the State Council.
Article30
The evaluation and research organs on non-clinic safety of
pharmaceuticals and the experimental clinic organs shall enforce
the quality administration criteria on non-clinic research
and the quality administration criteria on clinic research
respectively.
The quality administration criteria on non-clinic research
and the quality administration criteria on clinic research
shall be formulated by the department appointed by the State
Council.
Article31
To manufacture new pharmaceuticals or pharmaceuticals with
the national standard must be based on the approval of the
supervisory and administrative departments in charge of pharmaceuticals
of the State Council and obtain the serial approval number.
However, the Chinese medicine materials and crude slices on
which the administration of serial approval numbers is not
implemented shall be excluded. The catalogue of Chinese medicine
materials and crude slices under administration of serial
approval number shall be formulated by the supervisory and
administrative departments in charge of pharmaceuticals of
the State Council jointly with the administrative departments
in charge of Chinese medicines of the State Council.
Upon obtaining the serial approval number on the pharmaceutical,
the pharmaceutical manufacturing enterprises may manufacture
this pharmaceutical.
Article32
The pharmaceuticals must accord with the national pharmaceutical
standard. The Chinese medicine crude slices shall be enforced
according to Article 10 Paragraph 2 herein.
The pharmaceutical standard as provided by the Pharmaceutical
Codes of the People's Republic of China promulgated by the
supervisory and administrative departments in charge of pharmaceuticals
of the State Council shall be the national pharmaceutical
standard.
The supervisory and administrative departments in charge
of pharmaceuticals of the State Council shall organize the
pharmacopoeia committee to be in charge of the formulation
and revision of the national pharmaceutical standard.
The pharmaceutical examination organs of the supervisory
and administrative departments in charge of pharmaceuticals
of the State Council shall be in charge of demarcating the
national standard pharmaceutical and comparison.
Article33
The supervisory and administrative departments in charge of
pharmaceuticals of the State Council shall organize pharmaceutical,
medical, and other technical personnel to evaluate the new
pharmaceuticals and re-evaluate the pharmaceuticals that have
been put into production.
Article34
The pharmaceutical manufacturing enterprises, pharmaceutical
operation enterprises, and medical organizations must purchase
pharmaceuticals from enterprises with pharmaceutical manufacturing
or operation qualifications. However, the Chinese traditional
medicine materials for which the serial approval number administration
is not implemented shall be excluded.
Article35
The state implements the special administration on anesthetics,
psychotropic drugs, toxic pharmaceuticals for treatment, and
radioactive pharmaceuticals. The State Council shall formulate
the administrative measures
Article36
The state implements the system of Chinese traditional medicine
variety protection. The State Council shall formulate the
detailed measures.
Article37
The state implements the classified administration system
of prescription pharmaceuticals and non-prescription pharmaceuticals.
The State Council shall formulate the detailed measures
Article38
The pharmaceuticals with unreliable treatment effect, adverse
reaction, and other factors to endanger the health shall be
prohibited from being imported.
Article39
The import of pharmaceuticals shall be examined and verified
by the supervisory and administrative departments in charge
of pharmaceuticals of the State Council. Safe and effective
pharmaceuticals that accord with the quality standard upon
examination and verification may be imported and the import
pharmaceutical registration certificates shall be granted
to them.
The important procedures shall be transacted according to
the relevant provisions of the state for import pharmaceuticals
that are needed by the medical units or individuals urgently.
Article40
Pharmaceuticals must be imported from the port from which
the pharmaceuticals are allowed to enter China, and the enterprise
that imports these pharmaceuticals shall register with the
supervisory and administrative departments in charge of pharmaceuticals
of the port. The customs shall release these pharmaceuticals
by the Customs Declaration Bills of Import Pharmaceuticals
issued by the supervisory and administrative departments in
charge of pharmaceuticals. Otherwise, the customs shall not
release them.
The supervisory and administrative departments in charge
of pharmaceuticals of the port shall notify the pharmaceutical
inspection organs to selectively inspect the import pharmaceuticals
according to the provisions of the supervisory and administrative
departments in charge of pharmaceuticals of the State Council,
and shall collect inspection fees according to Article 41
Paragraph 2 herein.
The ports from which pharmaceuticals are allowed to enter
China shall be nominated by the supervisory and administrative
departments in charge of pharmaceuticals of the State Council
jointly with the State Administration of Customs, and shall
be reported to the State Council for approval.
Article41
the supervisory and administrative departments in charge of
pharmaceuticals of the State Council shall appoint pharmaceutical
inspection organs to inspect the following pharmaceuticals
before selling or upon import. Unqualified pharmaceuticals
upon inspection shall not be sold or imported:
(1) Biological pharmaceuticals as provided by the supervisory
and administrative departments in charge of pharmaceuticals
of the State Council;
(2) Pharmaceuticals that are sold in China for the first
time; and
(3) Other pharmaceuticals as provided by the State Council.
The inspection fee items and charging criteria of the aforesaid
pharmaceuticals shall be verified and proclaimed by the financial
departments of the State Council jointly with the supervisory
and administrative departments in charge of pharmaceuticals
of the State Council.
Article42
The supervisory and administrative departments in charge of
pharmaceuticals of the State Council shall organize investigation
on pharmaceuticals that have been approved for production
or import pharmaceuticals. As to pharmaceuticals with unreliable
treatment effect or adverse reaction, or other pharmaceuticals
endangering the health of the human body, the serial approval
number or import pharmaceutical registration certificate shall
be revoked.
Pharmaceuticals whose serial approval numbers or import pharmaceutical
registration certificates have been revoked shall not be manufactured,
imported, sold, or used; such pharmaceuticals that have been
imported or manufactured shall be destroyed or disposed by
the local supervisory and administrative departments in charge
of pharmaceuticals.
Article43
The state implements the pharmaceutical reserve system.
When serious disaster situation or epidemic situation and
other outburst accidents occur in the state, the departments
as provided by the State Council may transfer pharmaceuticals
of enterprises urgently.
Article44
The State Council shall have the right to restrict or prohibit
pharmaceuticals with insufficient supplies in China from being
exported.
Article45
To import and export anesthetics and psychotropic drugs within
the range prescribed by the state, the Import Permit and Export
Permit issued by the supervisory and administrative departments
in charge of pharmaceuticals of the State Council must be
possessed
Article46
Pharmaceutical materials that are newly discovered or introduced
from abroad may be sold upon the examination and verification
of the supervisory and administrative departments in charge
of pharmaceuticals of the State Council.
Article47
The measures on administration of regional civilian habitually
used pharmaceutical materials shall be formulated by the supervisory
and administrative departments in charge of pharmaceuticals
of the State Council and the administrative departments in
charge of Chinese traditional medicine of the State Council.
Article48
The fake pharmaceuticals shall be prohibited from being manufactured
(including prepared, hereinafter inclusive).
If falling into one of the following situations, the pharmaceutical
shall be the fake pharmaceutical:
(1) The ingredients contained by the pharmaceutical do not
accord with the ingredients as prescribed by the national
pharmaceutical standard; and
(2) Using the non-pharmaceutical to imitate the pharmaceutical
or using one kind of pharmaceutical to imitate the other pharmaceutical;
If falling into one of the following situations, the pharmaceutical
shall be regarded as the fake pharmaceutical:
(1) Pharmaceuticals prohibited by the supervisory and administrative
departments in charge of pharmaceuticals of the State Council
from being used;
(2) The pharmaceuticals whose manufacture or import shall
be approved according to this Law are manufactured or imported
without approval, or the pharmaceuticals that shall be sold
upon inspection according to this Law are sold without inspection;
(3) Denatured pharmaceuticals;
(4) Polluted pharmaceuticals;
(5) Pharmaceuticals that are manufactured by the raw materials
without obtaining the serial approval number that must be
obtained; and
(6) Pharmaceuticals whose indicated application of diseases
or main functions exceed the prescribed range.
Article49
Inferior pharmaceuticals shall be prohibited from being manufactured:
(1) Pharmaceuticals whose validity period is not indicated
or changed;
(2) Pharmaceuticals whose production serial numbers are not
indicated;
(3) Pharmaceuticals beyond the validity period;
(4) Pharmaceuticals whose packing materials and containers
directly touching them are not used upon approval;
(5) Pharmaceuticals with added colorant, antiseptic, flavor,
taste corrector, and accessory materials without authorization;
and
(6) Other pharmaceuticals that do not accord with the pharmaceutical
standard.
Article50
The pharmaceutical appellations listed in the national pharmaceutical
standard shall be general appellations of pharmaceuticals.
The general appellations of pharmaceuticals shall not be used
as trademarks.
Article51
The health examination for staffs who directly touch pharmaceuticals
of the pharmaceutical manufacturing enterprises, pharmaceutical
operation enterprises and medical organizations shall be carried
through every year. Any staff with infectious disease or other
diseases that are possible to pollute pharmaceuticals shall
not be engaged in the working of touching pharmaceuticals
directly.
Chapter 6 Administration of Packing of Pharmaceuticals
Article52
Packing materials and containers that directly touch pharmaceuticals
must accord with the relevant requirements, accord with the
standard of safeguarding the health and security of human
body, and shall be examined and approved by the supervisory
and administrative departments in charge of pharmaceuticals
jointly when examining and approving pharmaceuticals.
Pharmaceutical manufacturing enterprises shall not use packing
materials and containers that directly touch pharmaceuticals
without approval.
Unqualified packing materials and containers that directly
touch pharmaceuticals shall be ordered by the supervisory
and administrative departments in charge of pharmaceuticals
to be discontinued.
Article53
Packing materials must accord with requirements of the quality
of pharmaceuticals and shall be convenient for storage, transportation
and treatment.
Packing materials must be used for delivery of Chinese traditional
medicinal materials. The item name, place of origin, date,
and transfer unit must be indicated on each packing, and the
symbol of qualified quality must be attached.
Article54
Labels shall be printed or affixed on, and the specification
must be attached to the packing of pharmaceuticals according
to the relevant provisions.
The label or specification must indicate clearly the general
appellation of the pharmaceutical, ingredients, specifications,
manufacturing enterprise, serial approval number, lot number,
manufacturing date, validity period, applicable disease or
main functions, usage, dosage, incompatibility£adverse
reaction, and proceedings of attention.
Labels of anesthetics, psychotropic drugs, toxic pharmaceuticals
for treatment, radioactive pharmaceuticals, prescription pharmaceuticals,
and non-prescription pharmaceuticals must have the prescriptive
printed signs.
Chapter 7 Administration of Price and Advertisement of Pharmaceuticals
Article55
As to pharmaceuticals under fixed price and guiding price
of the government, the administrations of price control of
the people's governments shall formulate and adjust the price
of pharmaceuticals according to the pricing principle as provided
by the Law of the People's Republic of China on Price, the
social average cost, the marketing supply and demand conditions,
and social bearing capability, to reach balanced price and
quality, to eliminate the falsely high price, and to protect
the legal rights and interests of the pharmaceutical users.
Pharmaceutical manufacturing enterprises, pharmaceutical
operation enterprises, and medical organizations must execute
the fixed price and guiding price of the government, and shall
not huff the price by any means without authorization.
Pharmaceutical manufacturing enterprises shall provide the
production and operation cost of pharmaceuticals to the administrations
of price control of the people's governments according to
facts and law, and shall not refuse to report, falsely report,
and conceal the cost.
Article56
As to pharmaceuticals under market regulatory price according
to law, the pharmaceutical manufacturing enterprises, pharmaceutical
operation enterprises, and medical organizations shall formulate
the price according to the principle of "equity, fairness,
good faith, and reasonable quality to price ratio" and
provide pharmaceuticals to users with tenable price.
The pharmaceutical manufacturing enterprises, pharmaceutical
operation enterprises, and medical organizations shall abide
by the provisions of the administrations of price control
of the State Council on pharmaceutical price, and shall formulate
and indicate the retail price of pharmaceutical. Swindling
acts concerning price such as sudden huge profits and damaging
interests of pharmaceutical users shall be prohibited.
Article57
The pharmaceutical manufacturing enterprises, pharmaceutical
operation enterprises, and medical organizations shall provide
such data as actual purchase and sale price and amount of
pharmaceuticals to the administrations of price control of
the State Council according to law.
Article58
The medical organizations shall provide the price list of
used pharmaceuticals to patients, and the medical organizations
appointed by the medical insurance shall proclaim the price
of common pharmaceuticals according to the relevant measures
based on facts, and strengthen the administration of reasonable
pharmaceutical usage.
The detailed measures shall be formulated by the administrative
departments in charge of the public health under the State
Council.
Article59
The pharmaceutical manufacturing enterprises, pharmaceutical
operation enterprises, and medical organizations shall be
prohibited from giving or accepting discount or other profits
beyond the books in the course of pharmaceutical purchase
and sale.
The pharmaceutical manufacturing enterprises and pharmaceutical
operation enterprises or their deputies shall be prohibited
from giving properties or other profits to the principals,
pharmaceutical buyers, physicians, and so on of the medical
organizations that use pharmaceuticals in any name. The principals,
pharmaceutical buyers, physicians, and so on of the medical
organizations that use pharmaceuticals shall be prohibited
from accepting properties or other profits given by the pharmaceutical
manufacturing enterprises and pharmaceutical operation enterprises
or their deputies.
Article60
Pharmaceutical advertisements shall be examined and approved
by the supervisory and administrative departments in charge
of pharmaceuticals of the province, autonomous region, or
municipality directly under the Central People's Government
in which the enterprises are located. These advertisements
may be published upon the serial approval number; otherwise,
they shall not be published.
The prescription pharmaceuticals may be introduced on the
medical or pharmaceutical publications appointed by the administrative
departments in charge of health of the State Council and the
supervisory and administrative departments in charge of pharmaceuticals
of the State Council jointly. However, advertisements on public
media shall not be allowed or other advertisements or propaganda
whose object is the public shall not be allowed.
Article61
Contents of pharmaceutical advertisements shall be true and
legal based on the specifications approved by the supervisory
and administrative departments in charge of pharmaceuticals
of the State Council. False contents shall be prohibited.
Pharmaceutical advertisements shall not contain non-scientific
affirmation or guarantee on functions. Names and images of
experts, scholars, physicians, and patients, or government
agencies, medical research units, and academic organs shall
be prohibited from being used as proof.
Non-pharmaceutical advertisements shall not concern propaganda
on pharmaceuticals.
Article62
the supervisory and administrative departments in charge of
pharmaceuticals of all provinces, autonomous regions, and
municipalities directly under the Central People's Government
shall censor pharmaceutical advertisements approved by them.
As to advertisements in violation of this Law and the Law
of the People's Republic of China on Advertisements, they
shall circularly notify the supervisory and administrative
departments in charge of advertisements and raise the handling
proposals, and the supervisory and administrative departments
in charge of advertisements shall handle these cases according
to law.
Article63
If this Law does not make complete stipulations on pharmaceutical
price and advertisements, the Law of the Republic of China
on Price and the Law of the People's Republic of China on
Advertisements shall be applicable.
Chapter 8 Supervision over Pharmaceuticals
Article64
The supervisory and administrative departments in charge of
pharmaceuticals shall have the right to inspect and supervise
proceedings of using pharmaceuticals by the pharmaceutical
manufacturing enterprises, pharmaceutical operation enterprises,
and medical organizations that are examined and approved by
them according to the relevant laws or administrative regulations;
the correlated units or individuals shall not refuse and conceal
the inspection and supervision.
When implementing the inspection and supervision, the supervisory
and administrative departments in charge of pharmaceuticals
must show the certificates and shall keep secrets of the technical
and business secrets of the inspected and supervised.
Article65
The supervisory and administrative departments in charge of
pharmaceuticals may inspect the pharmaceutical quality selectively
according to needs of supervision and inspection. In the course
of selective inspection, the sampling must be carried through
without any charge, and the needed expenses shall be paid
according to the relevant provisions of the State Council.
The supervisory and administrative departments in charge
of pharmaceuticals may adopt mandatory administrative measures
such as sealing-up and detention for pharmaceuticals and correlated
materials that are possible to endanger the health of the
human body, and shall make an administrative handling decision
within seven days. If the pharmaceuticals need to be inspected,
the administrative decision must be made within fifteen days
upon the issuing of the inspection report.
Article66
The supervisory and administrative departments in charge of
pharmaceuticals of the State Council or all provinces, autonomous
regions, and municipalities directly under the Central People's
Government shall regularly proclaim the results of selective
inspection on pharmaceutical quality. If the proclamation
is not appropriate, correction within the range of the original
proclamation must be made.
Article67
The interested party, if having objections to the inspection
results, may files an application to the original pharmaceutical
inspection organ or the next higher supervisory and administrative
department in charge of pharmaceuticals or the determinate
pharmaceutical inspection organ for re-inspection, or may
directly files an application to the supervisory and administrative
departments in charge of pharmaceuticals of the State Council
or the determinate pharmaceutical inspection organ for re-inspection.
The pharmaceutical inspection organ that accepts the re-inspection
shall make a re-inspection conclusion within the time limit
as provided by the supervisory and administrative departments
in charge of pharmaceuticals of the State Council.
Article68
The supervisory and administrative departments in charge of
pharmaceuticals shall carry through the following-up inspection,
upon authentication, on qualified pharmaceutical manufacturing
enterprises and pharmaceutical operation enterprises according
to the Administrative Criteria on Pharmaceutical Manufacturing
Quality and the Administrative Criteria on Pharmaceutical
Operation Quality.
Article69
The local people's governments and the supervisory and administrative
departments in charge of pharmaceuticals shall not restrict
or exclude pharmaceuticals manufactured by non-local pharmaceutical
manufacturing enterprises according to this Law from entering
their own administrative regions by means of requiring pharmaceutical
inspection, examination, and approval.
Article70
The supervisory and administrative departments in charge of
pharmaceuticals, their established pharmaceutical inspection
organs, and determinate organs specializing in pharmaceutical
inspection shall not take part in the pharmaceutical manufacture
and operation activities, and shall not recommend or supervise
the manufacture and sales of pharmaceuticals.
Staffs of the supervisory and administrative departments
in charge of pharmaceuticals, their established pharmaceutical
inspection organs, and determinate organs specializing in
pharmaceutical inspection shall not take part in the pharmaceutical
manufacture and operation activities.
Article71
The State implements the system of reporting adverse reaction
of pharmaceuticals. The pharmaceutical manufacturing enterprises,
pharmaceutical operation enterprises, and medical organizations
must investigate regularly the quality, treatment effect,
and reaction of pharmaceuticals manufactured, operated, and
used by their own units. Serious adverse reaction related
to the pharmaceuticals shall be reported to the local supervisory
and administrative departments in charge of pharmaceuticals
and administrative departments in charge of health of all
provinces, autonomous regions, and municipalities directly
under the Central People's Government in time. The detailed
measures shall be formulated by the supervisory and administrative
departments in charge of pharmaceuticals of the State Council
jointly with the administrative departments in charge of health
of the State Council.
The supervisory and administrative departments in charge
of pharmaceuticals of the State Council or all provinces,
autonomous regions, and municipalities directly under the
Central People's Government may adopt emergent control measures
on stopping manufacturing, selling, or using pharmaceuticals
whose adverse reaction has been confirmed, and shall organize
an appraisal within five days. The administrative handling
decision shall be made according to law within fifteen days
upon the making date of the appraisal conclusion.
Article72
Pharmaceutical inspection organs or personnel of the pharmaceutical
manufacturing enterprises, pharmaceutical operation enterprises,
and medical organizations shall accept the business guidance
from the pharmaceutical inspection organs set up by the local
supervisory and administrative departments in charge of pharmaceuticals.
Chapter 9 Legal Liabilities
Article73
Any enterprise that manufactures or operates pharmaceuticals
without obtaining the Pharmaceutical Manufacture License,
the Pharmaceutical Operation License, or the Medicament License
for Medical Organizations shall be outlawed according to law.
The illegally manufactured and sold pharmaceuticals and illegal
gains shall be confiscated; a fine of more than twice of the
value of illegally manufactured and sold pharmaceuticals (including
pharmaceuticals that have been or have not been sold, hereinafter
inclusive) but less than five times of this value shall be
imposed. It shall be prosecuted for criminal liabilities if
its acts constitute a crime.
Article74
Any enterprise that manufactures or sells fake pharmaceuticals
shall be imposed a fine of more than twice of the value of
illegally manufactured and sold pharmaceuticals but less than
five times of this value; the illegal manufactured and sold
pharmaceuticals and illegal gains shall be confiscated. The
pharmaceutical certificates, if any, shall be revoked and
this enterprise shall be ordered to stop production and make
internal rectification. If its circumstances are serious,
the Pharmaceutical Manufacture License, the Pharmaceutical
Operation License, or the Medicament License for Medical Organizations
shall be revoked. It shall be prosecuted for criminal liabilities
if its acts constitute a crime.
Article75
Any enterprise that manufactures or sells inferior pharmaceuticals
shall be imposed a fine of more than one time of the value
of illegally manufactured and sold pharmaceuticals but less
than five times of this value; the illegal manufactured and
sold pharmaceuticals and illegal gains shall be confiscated.
If its circumstances are serious, the pharmaceutical certificates,
if any, may be revoked or this enterprise may be ordered to
stop production and make internal rectification the Pharmaceutical
Manufacture License, the Pharmaceutical Operation License,
or the Medicament License for Medical Organizations shall
be revoked. It shall be prosecuted for criminal liabilities
if its acts constitute a crime.
Article76
The directly responsible directors and other directly responsible
personnel of enterprises or other operation units that engage
in manufacturing or selling fake pharmaceuticals and manufacturing
or selling inferior pharmaceuticals with serious circumstances
shall not engage in pharmaceuticals manufacture and operation
activities.
The raw materials, accessory materials, and packing materials,
and equipment used specially for manufacturing fake or inferior
pharmaceuticals shall be confiscated.
Article77
Any unit or individual who knows or should know the pharmaceuticals
are fake or inferior pharmaceuticals and provide convenience
for transporting, storing, and warehousing such pharmaceuticals
shall be imposed on a fine of more than 50% but less than
three times of illegal gains, and the total income from transportation,
storage and warehousing shall be confiscated. It or he shall
be prosecuted for criminal liabilities if its or his acts
constitute a crime.
Article78
The penalty notice on fake or inferior pharmaceuticals must
indicate the quality inspection results of the relevant pharmaceutical
inspection organ, unless it falls into one of the situations
as provided by Article 48 Paragraph 3 Item 1, 2, 5, 6 and
Article 49 Paragraph 3.
Article79
Pharmaceutical manufacturing enterprises, pharmaceutical operation
enterprises, the evaluation and research organs on pharmaceutical
non-clinic security, and the clinic testing organs of pharmaceuticals
shall be given a warning and ordered to make corrections within
a specified time limit if they do not implement the quality
administration criteria according to the Administrative Criteria
on Pharmaceutical Manufacturing Quality, the Administrative
Criteria on Pharmaceutical Operation Quality, the administrative
criteria on quality of non-clinic pharmaceutical research
, or the administrative criteria on quality of clinic pharmaceutical
testing. If they do not make corrections within the specified
time limit, they shall be ordered to stop production and make
internal rectification, and a fine of more than RMB 5,000
but less than RMB 20,000 shall be imposed. If their circumstances
are serious, their Pharmaceutical Manufacture Licenses, or
the Pharmaceutical Operation Licenses, or clinic testing qualifications
shall be revoked.
Article80
Pharmaceutical manufacturing enterprises, pharmaceutical operation
enterprises, and medical organizations that, in violation
of Article 34 herein, purchase illegal pharmaceuticals from
enterprises without the Pharmaceutical Manufacturing License
or the Pharmaceutical Operation License shall be ordered to
make corrections; the illegally purchased pharmaceuticals
shall be confiscated; and a fine of more than twice of but
less than five times of the value of illegally purchased pharmaceuticals
shall be confiscated jointly. The illegal gains, if any, shall
be confiscated. If their circumstances are serious, the Pharmaceutical
Manufacture License, the Pharmaceutical Operation License,
or the certified licenses for medical organizations shall
be confiscated.
Article81
Any enterprise that imports pharmaceuticals on which the import
registration certificates have been granted and does not register
with the supervisory and administrative department in charge
of pharmaceuticals of the port from which pharmaceuticals
are allowed to enter China shall be given a warning, and ordered
to make corrections in a specified time limit. If it does
not make corrections in the specified time limit, the pharmaceutical
import registration certificates shall be revoked.
Article82
Any unit or individual who fabricates, alters, buys, sells,
releases, or lends licenses or pharmaceutical approval documents
shall be imposed upon a fine of more than one time but less
than three times of illegal gains and the illegal gains shall
be confiscated. If there are no illegal gains, a fine of more
than RMB 20,000 but less than RMB 100,000 shall be imposed.
If the circumstances are serious, the Pharmaceutical Manufacture
License, the Pharmaceutical Operation License, or the Medicament
License for Medical Organizations of the buyer, seller, or
lender shall be revoked, or the pharmaceutical approval documents
shall be revoked. If his acts constitute a crime, he shall
be prosecuted for criminal liabilities.
Article83
Any enterprise that, in violation of this Law, obtains the
Pharmaceutical Manufacture License, the Pharmaceutical Operation
License, or the Medicament License for Medical Organizations,
or pharmaceutical approval documents by swindling means such
as providing false certificates, materials, data, or other
means shall be imposed on a fine of more than RMB 10,000 but
less than RMB 30,000. The aforesaid licenses or documents
shall be confiscated, and its application for such licenses
shall not be accepted within five years.
Article84
Any medical organization that sells its compounded medicaments
on the market shall be ordered to make correction, and the
sold medicaments illegally shall be confiscated, and a fine
of more than one time but less than three times of the value
of illegal sold medicaments shall be imposed on it jointly.
The illegal gains, if any, shall be confiscated.
Article85
Any pharmaceutical operation enterprise in violation of Article
18 and Article 19 of this Law shall be ordered to make corrections
and given a warning. If its circumstances are serious, its
Pharmaceutical Operation License shall be revoked.
Article86
Any enterprise whose pharmaceutical labels do not accord with
Article 54 herein shall be ordered to make corrections and
given a warning. These pharmaceuticals shall be regarded as
the inferior or fake pharmaceuticals. If its circumstances
are serious, the pharmaceutical approval documents shall be
revoked.
Article87
Any pharmaceutical inspection organ that issues the false
inspection report and constitutes a crime shall be prosecuted
for its criminal liabilities. If its acts do not constitute
a crime, it shall be ordered to make corrections and given
a warning, and a fine of more than RMB 30,000 but less than
RMB 50,000 shall be imposed on the unit. The directly responsible
directors and other directly responsible persons shall be
given sanctions such as degrading, dismissing for offices
or discharge and a fine of less than RMB 30,000 shall be imposed
on them. The illegal gains, if any, shall be confiscated.
If the circumstances are serious, its inspection qualification
shall be revoked. If the inspection results issued by it are
not true and cause losses therefore, it shall bear the corresponding
compensation liabilities.
Article88
The administrative punishments as stipulated by Article 73
to Article 87 herein shall be decided by the supervisory and
administrative departments in charge of pharmaceuticals at
and above the county level according to the responsibilities
and work division as provided by the supervisory and administrative
departments in charge of pharmaceuticals of the State Council.
The decision of revoking the Pharmaceutical Manufacture License,
the Pharmaceutical Operation License, the Medicament License
for Medical Organizations, the certified licenses for medical
organizations, or the pharmaceutical approval documents shall
be made by the original license-issuing or approving departments.
Article89
Any unit in violation of Article 55, 56, and 57 on administration
of pharmaceutical price shall be punished according to the
Law of the People's Republic of China on Price.
Article90
The pharmaceutical manufacturing enterprises, pharmaceutical
operation enterprises, and medical organizations that give
or accept discount or other profits in the dark, or the pharmaceutical
manufacturing enterprises, pharmaceutical operation enterprises,
and medical organizations or their deputies that give properties
or other profits to the principals, pharmaceutical buyers,
and physicians of the medical organizations that use their
pharmaceuticals shall be imposed upon a fine of more than
RMB 10,000 but less than RMB 200,000. The illegal gains, if
any, shall be confiscated. If their circumstances are serious,
the administrations of industry and commerce shall revoke
their business licenses, and shall notify the supervisory
and administrative departments in charge of pharmaceuticals
to revoke their Pharmaceutical Manufacturing Licenses or Pharmaceutical
Operation Licenses. If their acts constitute crimes, they
shall be prosecuted for criminal liabilities.
Article91
Principals, buyers, and so on of the pharmaceutical manufacturing
and operation enterprises who accept properties or other profits
given by other pharmaceutical manufacturing or operation enterprises
or their deputies in the course of pharmaceutical purchase
and sale shall be given sanctions according to law. The illegal
gains shall be confiscated. If they commit crimes, they shall
be prosecuted for criminal liabilities.
Principals, pharmaceutical buyers, or physicians of the medical
organizations who accept properties or other profits given
by other pharmaceutical manufacturing or operation enterprises
or their deputies shall be given sanctions by their units
or the administrative departments in charge of health. The
illegal gains shall be confiscated. The certified licenses
of the certified physicians with illegal serious circumstances
shall be confiscated by the administrative departments in
charge of health. If they commit crimes, they shall be prosecuted
for criminal liabilities.
Article92
Any unit in violation of this Law on administration of pharmaceutical
advertisements shall be punished according to the Law of the
Republic of China. Its advertisement approval numbers shall
be revoked by the supervisory and administrative department
in charge of pharmaceuticals that issued these numbers. Its
application for examination and approval of the advertisement
shall not be accepted within one year. If its acts constitute
crimes, it shall be prosecuted for criminal liabilities.
If the supervisory and administrative departments in charge
of pharmaceuticals do not perform responsibilities on inspection
of pharmaceutical advertisements according to law, and the
advertisements approved by them have false contents or other
contents in violation of laws or administrative regulations,
the directly responsible directors and other directly responsible
persons shall be given administrative sanctions. If they commit
crimes, they shall be prosecuted for criminal liabilities.
Article93
The pharmaceutical manufacturing enterprises, pharmaceutical
operation enterprises, and medical organizations that, in
violation of this Law, cause damage to users, shall bear compensation
liabilities according to law.
Article94
The supervisory and administrative departments in charge of
pharmaceuticals that, in violation of this Law, have one of
the following acts, shall be ordered by the next higher departments
or supervisory organs to recall licenses and pharmaceutical
approval documents issued by them illegally. The directly
responsible directors and other directly responsible personnel
shall be given administrative sanctions according to law.
If they commit crimes, they shall be prosecuted for criminal
liabilities:
(1) Issuing authentication certificates to enterprises that
do not accord with the Administrative Criteria on Pharmaceutical
Manufacturing Quality or the Administrative Criteria on Pharmaceutical
Operation Quality; not performing following-up inspection
on enterprises that obtained authentication certificates according
to the relevant provisions; or not ordering unqualified enterprises
upon authentication to make corrections or not revoking their
authentication certificates;
(2) Issuing the Pharmaceutical Manufacture License, the Pharmaceutical
Operation License, or the Medicament License for Medical Organizations
to unqualified units;
(3) Issuing pharmaceutical import registration certificates
to pharmaceuticals that do not accord with the import requirements;
or
(4) Approving the clinic testing, issuing new pharmaceutical
certificate, or issuing serial approval numbers to enterprises
without clinic qualifications or manufacturing qualifications.
Article95
If the supervisory and administrative departments in charge
of pharmaceuticals, their established pharmaceutical inspection
organs, or their determinate organs specializing in pharmaceutical
inspection take part in pharmaceutical manufacture and operation
activities, their next higher departments or supervisory organs
shall order them to make corrections. The illegal gains, if
any, shall be confiscated. If their circumstances are serious,
the directly responsible directors and other directly responsible
personnel shall be given administrative sanctions according
to law.
Staffs of the supervisory and administrative departments
in charge of pharmaceuticals, their established pharmaceutical
inspection organs, or their determinate organs specializing
in pharmaceutical inspection who take part in pharmaceutical
manufacture and operation activities shall be given administrative
sanctions according to law.
Article96
If the supervisory and administrative departments in charge
of pharmaceuticals, their established pharmaceutical inspection
organs, or their determinate organs specializing in pharmaceutical
inspection collect inspection charges illegally, the relevant
departments of the people's governments shall order them to
return these charges. The directly responsible directors and
other directly responsible personnel shall be given administrative
sanctions according to law. The inspection qualifications
of the pharmaceutical inspection organs that collect inspection
charges illegally with serious circumstances shall be revoked.
Article97
The supervisory and administrative departments in charge of
pharmaceuticals shall perform the duties of supervision and
inception according to law, and shall supervise enterprises
that have obtained the Pharmaceutical Manufacture Licenses
or the Pharmaceutical Operation Licenses to engage in pharmaceutical
manufacturing or operation activities as provided by this
Law. Enterprises that have obtained the Pharmaceutical Manufacture
Licenses or the Pharmaceutical Operation Licenses and manufacture
or sell fake or inferior pharmaceuticals shall be prosecuted
for legal liabilities. Moreover, administrative sanctions
shall be given to directly responsible directors and other
directly responsible persons of the supervisory and administrative
departments in charge of pharmaceuticals with acts of breach
of duties or malfeasance. If they commit crimes, they shall
be prosecuted for criminal liabilities.
Article98
The supervisory and administrative department in charge of
pharmaceuticals shall order its next lower supervisory and
administrative departments in violation of this Law to make
correction within a specified time limit. It has the right
to change or revoke them if they do not make corrections within
the specified time limit.
Article99
Personnel of pharmaceutical supervision and administration
who abuse their authorities, practice their favoritism, neglect
their duties shall be prosecuted for their criminal liabilities
if they commit crimes or shall be given administrative sanctions
if they do not commit a crime.
Article100
The supervisory and administrative departments in charge of
pharmaceuticals shall notify the administrations of industry
and commerce to transact alteration or revocation registrations
for enterprises whose Pharmaceutical Manufacture Licenses
or Pharmaceutical Operation Licenses have been revoked according
to this Law.
Article101
The value of goods as referred to herein shall be calculated
by the marked price of the illegally manufactured or sold
pharmaceuticals. If there are no marked prices, the market
price of the like pharmaceuticals shall be used.
Chapter 10 Supplementary Rules
Article102
The meaning of the terms referred to herein shall be as follows:
Pharmaceuticals shall mean materials that are used for preventing,
treating, or diagnosing diseases of the people, and regulating
the physiological functions, with prescribed applicable diseases,
main functions, usage, and dosage, including Chinese traditional
medicinal materials, Chinese medicine crude slices, prepared
Chinese medicines, chemical raw material pharmaceuticals and
their preparation, antibiotics, biochemical pharmaceuticals,
radioactive pharmaceuticals, blood serum, vaccine, blood products,
and diagnosis pharmaceuticals, etc.
The accessory materials shall mean the excipients and additives
when prepare prescription or manufacture pharmaceuticals.
Pharmaceutical manufacturing enterprises shall mean enterprises
that specialize in manufacturing pharmaceuticals or concurrently
manufacture pharmaceuticals.
Pharmaceutical operation enterprises shall mean enterprises
that specialize in operating pharmaceuticals or concurrently
operate pharmaceuticals.
Article103
The State Council shall otherwise formulate the administrative
measures on cultivation, gathering, and breeding of Chinese
traditional medicinal materials.
Article104
The state implements special administration on circulation
of preventive biological products. The detailed measures shall
be formulated by the State Council
Article105
The detailed measures for the People's Liberation Army to
enforce this Law shall be formulated by the State Council
and the Central Military Commission according to this Law.
Article106
This Law shall take effect as of 1st December 2001.
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