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The Standing Committee of the National People’s Congress
Order of the President of the People’s Republic of China
No.45
The Pharmaceutical Administration Law of the People’s Republic of China has been revised at the Twentieth Meeting of the Standing
Committee of the Ninth National People’s Congress on February 28, 2000, and now promulgated the revised edition of the Pharmaceutical
Administration Law of the People’s Republic of China, and shall enter into force as of December 1, 2001.
Jiang Zemin, President of the People’s Republic of China
February 28, 2001
Pharmaceutical Administration Law of the People’s Republic of China ContentsChapter I General Provisions
Chapter II Administration of Pharmaceutical Producing Enterprises
Chapter III Administration of Pharmaceutical Trading Enterprises
Chapter IV Administration of Pharmaceuticals at Medical Organizations
Chapter V Pharmaceutical Administration
Chapter VI Administration of the Packaging of Pharmaceuticals
Chapter VII Administration of the Prices and Advertising of Pharmaceuticals
Chapter VIII Supervision over Pharmaceuticals
Chapter IX Legal Responsibility
Chapter X Supplementary Provisions
Chapter I General Provisions
Article 1
This law is formulated to enhance the supervision and control of pharmaceuticals, ensure their quality, guarantee safety in medication,
and safeguard the health and legal rights and interests of the people.
Article 2
The law shall be applicable to any units or individuals engaged in research, production, trade, use, supervision and management of
pharmaceuticals within the territory of the People’s Republic of China.
Article 3
The State shall develop both modern and traditional medicines encourage their role in the prevention and treatment of diseases and
in health care.
The State shall protect the resources of wild medicinal resources and encourage the domestic cultivation of Chinese traditional medicinal
crops.
Article 4
The State shall encourage the research and production of new medicine and protect the legal rights and interests of its citizens,
natural persons and other organizations in the research and development of new medicine.
Article 5
The pharmaceuticals supervisory and administrative departments under the State Council shall be responsible for the supervision and
control of pharmaceuticals throughout the country. Other relevant departments under the State Council shall be responsible for the
supervision and control of pharmaceuticals related to the scope of their functions.
The pharmaceutical supervisory and administrative departments of the provinces, autonomous regions and municipalities directly under
the central government shall be responsible for the supervision and control of pharmaceuticals within their administrative regions.
Other relevant departments of the provinces, autonomous regions and municipalities directly under the central government shall be
responsible for the supervision and control of pharmaceuticals related to the scope of their functions.
The pharmaceutical supervisory and administrative departments under the State Council shall cooperate with the general administrative
department of the economy under the State Council to carry out pharmaceutical development plans and industrial policies formulated
by the State.
Article 6
The pharmaceutical inspection institutions established or approved by the pharmaceutical supervisory and administrative departments
shall be charged with the work of pharmaceutical examination and approval, as well as quality inspection, in accordance with laws
and regulations.
Chapter II Administration of Pharmaceutical Producing Enterprises
Article 7
The establishment of a pharmaceutical producing enterprise must be approved by and issued a Pharmaceutical Production License by the
pharmaceutical supervisory and administrative department of the province, autonomous region, or municipality directly under the Central
government in which the enterprise is located.
The establishment shall be registered at the industry and commerce administrative department based on the Pharmaceutical Production
License, without which no pharmaceuticals shall be produced.
The Pharmaceutical Production License shall bear the scope of production and a period of validity, and upon expiration a new license
shall be issued after examination for its renewal.
The approval of the establishment of pharmaceutical producing enterprises by the pharmaceutical supervisory and administrative departments
shall be in conformity with Article 8 of this law, as well as the pharmaceutical development plan and the industrial policies formulated
by the State to avoid the instance of a repeat establishment.
Article 8
To establish a pharmaceutical producing enterprise, the following requirements must be met:
(1)
It shall be staffed with legally certified pharmaceutical technical personnel, engineering technical personnel, as well as corresponding
skilled workers.
(2)
It shall have factory premises, facilities and a sanitary environment suitable for the medicines produced.
(3)
It shall have a unit or competent personnel capable of inspecting the quality of the medicines produced, as well as necessary instruments
and equipment.
(4)
It shall have rules and regulations to ensure the quality of medicines.
Article 9
Pharmaceutical producing enterprises must organize production in accordance with the “Standards for Quality Control of Pharmaceutical
Production” formulated by the pharmaceutical supervisory and administrative departments under the State Council on the basis of this
Law. Pharmaceutical supervisory and administrative departments shall confirm whether the pharmaceutical producing enterprises have
met the requirements of the “Standards,” and shall issue certificates to those qualified ones.
The detailed implementation measures and implementation process of the “Standards for Quality Control of Pharmaceutical Production”
shall be formulated by the pharmaceutical supervisory and administrative department under the State Council.
Article 10
Except in the preparation of traditional Chinese medicines into ready-to-use forms, pharmaceuticals must be produced in accordance
with the national pharmaceutical standard and the technological procedures approved by the supervisory and administrative departments
of pharmaceuticals under the State Council, and the record of production must be complete and accurate. The changes of technological
procedure made by the pharmaceutical producing enterprises which affect the quality of the pharmaceuticals shall be examined and
approved by the original approval authorities.
The process for preparing traditional Chinese medicines into ready-to-use forms must conform to the national pharmaceutical standards,
and in the absence of such standards, the process must conform to the processing standards stipulated by the supervisory and administrative
departments of pharmaceuticals of the provinces, autonomous regions, or municipalities directly under the central government. The
processing standards stipulated by the supervisory and administrative departments of pharmaceuticals of the provinces, autonomous
regions, or municipalities directly under the central governments shall be placed on record at the pharmaceutical supervisory and
administrative department under the State Council.
Article 11
The raw and supplementary materials used for the production of pharmaceuticals must conform to the requirements for medicinal use.
Article 12
The pharmaceutical producing enterprises must conduct quality inspections on the pharmaceuticals they produce; products which do not
meet national pharmaceutical standards or are not prepared in conformity with the processing standards stipulated by the pharmaceutical
supervisory and administrative departments of the provinces, autonomous regions, or municipalities directly under the central government
shall not leave the factory.
Article 13
Pharmaceutical producing enterprises can accept the authorization to produce pharmaceuticals after they obtain approval from the pharmaceutical
supervisory and administrative department under the State Council or the pharmaceutical supervisory and administrative departments
of the provinces, autonomous regions, or municipalities directly under the central government authorized by the supervisory and administrative
department of pharmaceuticals under the State Council.
Chapter III Administration of Pharmaceutical Trading Enterprises
Article 14
The establishment of pharmaceutical wholesale enterprises must be sanctioned by the competent local authorities of the production
and trade of pharmaceuticals of the provinces, autonomous regions or municipalities directly under the central government, which
will issue a Pharmaceutical Trade License. The establishment of pharmaceutical retail enterprises must be sanctioned by local authorities
for the supervision and control of pharmaceuticals at or above the county level, which will issue a Pharmaceutical Trade License,
on the basis of which registration at the industry and commerce administrative departments shall be conducted. Without the Pharmaceutical
Trade License, any enterprises shall not engage in the trade of pharmaceuticals.
A Pharmaceutical Trade License shall bear a scope of trade and a period of validity, and upon expiration a new license shall be issued
after examination for its renewal.
The approval of the establishment of pharmaceutical trading enterprises by the pharmaceutical supervisory and administrative departments
shall adhere to the principle of reasonable positioning and convenience for buying of pharmaceuticals, and in addition must conform
to Article 15 of this Law.
Article 15
To establish a pharmaceutical trading enterprise, the following requirements must be met
(1)
1 It shall be staffed with legally certified pharmaceutical technical personnel.
(2)
It shall have business premises, equipment, storage facilities and a sanitary environment suitable for the pharmaceuticals in which
it trades.
(3)
It shall have a quality control organ or personnel suitable for the pharmaceuticals in which it trades.
(4)
It shall have rules and regulations to ensure the quality of the pharmaceuticals in which it trades.
Article 16
Pharmaceutical producing enterprises must trade in pharmaceuticals in accordance with the “Standards for Quality Control of Pharmaceutical
Trading” stipulated by the pharmaceutical supervisory and administrative departments under the State Council on the basis of this
Law. Pharmaceutical supervisory and administrative departments shall certify whether pharmaceutical trading enterprises meet the
requirements of the “Standards for Quality Control of Pharmaceutical Trading” in accordance with relevant regulations, and issue
certifications to qualified enterprises.
Detailed implementation measures and procedures for the “Standards for Quality Control of Pharmaceutical Trading” shall be stipulated
by the pharmaceutical supervisory and administrative departments under the State Council.
Article 17
Pharmaceutical trading enterprises must formulate and implement check and approval rules for the purchase of pharmaceuticals, and
check pharmaceutical certifications and other marks while purchasing pharmaceuticals. Pharmaceuticals that do not meet the required
standards must not be purchased.
Article 18
Pharmaceutical trading enterprises shall keep accurate and complete records of purchased pharmaceuticals. Purchasing records must
bear information on the pharmaceutical product’s generic names, types, specifications, batches, valid periods, producing enterprises,
purchasing (selling) units, purchasing (selling) quantity, purchasing and selling price, purchasing (selling) date and other contents
required by the pharmaceutical supervisory and administrative department under the State Council.
Article 19
It is imperative for pharmaceutical trading enterprises, in the sale of pharmaceuticals, to be accurate and free of mistakes, and
to provide correct directions for use, dosage and precautions. Prescriptions being dispensed must be checked. Pharmaceutical products
listed in the prescription must not be presumptuously changed or substituted. Prescriptions containing incompatible substances or
excessive dosages shall be rejected by the dispensary. If necessary, such prescriptions can be dispensed after they have been corrected
or re-signed by the doctors who wrote them.
When traditional Chinese medicinal materials are offered for sale by pharmaceutical trading enterprises, their origin must be indicated.
Article 20
Rules for storage of pharmaceuticals shall be formulated and implemented by pharmaceutical trading enterprises, which must adopt necessary
measures to facilitate cold storage and protection against freezing, moisture, insects and rodents to ensure pharmaceutical quality.
An inspection system shall be carried out for pharmaceuticals entering or leaving a warehouse
Article 21
Unless otherwise stipulated by the State, traditional Chinese medicinal materials may be marketed at urban or rural fairs.
Pharmaceuticals other than traditional Chinese medicinal materials may not be sold at urban or rural fairs, but those retail enterprises
which have the Pharmaceutical Trade License may set up stalls at urban or rural fairs to sell pharmaceuticals other than traditional
Chinese medicinal materials within prescribed areas. Detailed measures shall be stipulated by the State Council.
Chapter IV Administration of Pharmaceuticals at Medical Organizations
Article 22
Medical organizations must be staffed with legally certified pharmaceutical technical personnel. Non-pharmaceutical technical personnel
may not be directly engaged in the technical work of the pharmacy.
Article 23
To make medicinal preparations, a medical organization must be examined and approved by the administrative departments of health of
the provinces, autonomous regions, or municipalities directly under the central government where the organization is located , and
approved and issued a Dispensing Permit for Medical Organizations by the pharmaceutical supervisory and administrative departments
of the provinces, autonomous regions or municipalities directly under the central government. No medicinal preparations shall be
made without a Dispensing Permit for Medical Organizations.
The Dispensing Permit for Medical Organizations shall bear a period of validity, and upon expiration a new license shall be issued
after examination for its renewal.
Article 24
Medical organizations that make medicinal preparations must have facilities, a managerial system, inspection instruments, and a sanitary
environment to ensure quality.
Article 25
The medicinal preparations made by medical organizations shall be of the kinds that supply the clinical needs of the units themselves
but have not been supplied on the market, and must not be made until the approval of the pharmaceutical supervisory and administrative
departments of the provinces, autonomous regions and municipalities directly under the central government where the units are located.
The quality of the medicinal preparations made by medical organizations must be inspected in accordance with relevant regulations.
Those preparations conforming to standard can be used as the doctor prescribes. Under special circumstances, with approval from the
pharmaceutical supervisory and administrative departments of the central government or of the provinces, autonomous regions and municipalities
directly under the central government, the medicinal preparations made by medical organizations can be shared among appointed medical
organizations.
Medicinal preparations made by medical organizations may not be sold on the market.
Article 26
When purchasing pharmaceuticals, medical organizations must formulate and implement a system of quality inspection and check the certificates
and other marks of pharmaceuticals. Those pharmaceuticals that do not meet the requirements of relevant regulations shall not be
purchased and used.
Article 27
Prescriptions being dispensed by the dispensers of medical organizations must be checked. Pharmaceuticals listed in prescriptions
must not be presumptuously changed or substituted. Prescriptions containing incompatible substances or excessive dosages shall be
rejected by the dispensary. If necessary, such prescriptions can be dispensed after they have been corrected or re-signed by the
doctors who wrote them.
Article 28
Rules for storage of pharmaceuticals shall be formulated and implemented by medical organizations, which must adopt necessary measures
to facilitate cold storage and protection against cold, moisture, insects and rodents to ensure the quality of pharmaceuticals.
Chapter V Pharmaceutical Administration
Article 29
When producing a new medicine, it is necessary to submit information about the methods of production, quality indices, pharmacological
and toxicological testing results, and other related materials and sales as required by the pharmaceutical supervisory and administrative
department of the State Council, only after whose approval can clinical tests be carried out. Certifying measures for clinical test
units shall be jointly formulated by the pharmaceutical supervisory and administrative department under the State Council and the
administrative department of health under the State Council.
A new medicine which has completed its clinical tests and been approved after appraisal shall be issued a certificate of new medicine
by the pharmaceutical supervisory and administrative department under the State Council.
Article 30
The pharmaceutical non-clinical safety appraisal and research units and the clinical test units must respectively carry out the quality
control standard for pharmaceutical non-clinical research and the quality control standard for pharmaceutical clinical test.
The quality control standard for pharmaceutical non-clinical research and the quality control standard for pharmaceutical clinical
test shall be formulated by the department appointed by the State Council.
Article 31
A new medicine or medicine standardized by the State can be put into production only after the pharmaceutical supervisory and administrative
department under the State Council has approved it and issued a registered document of approval. However, this does not apply to
the production of traditional Chinese medicinal herbs and traditional Chinese medicine prepared in ready-to-use forms that are not
controlled under a registered document of approval. For those traditional Chinese medicinal herbs and traditional Chinese medicines
prepared in ready-to-use forms that are controlled with registered document of approval, the pharmaceutical supervisory and administrative
department under the State Council and the administrative department of traditional Chinese medicines under the State Council shall
jointly formulate their type catalogue.
Pharmaceutical producing enterprises can produce medicine only after obtaining the registered document of approval.
Article 32
Pharmaceuticals must meet the pharmaceutical standards of the State. Article 10 (2) of this Law shall be applied to traditional Chinese
medicines prepared in ready-to-use forms.
The “Pharmacopoeia of the People’s Republic of China” and the pharmaceutical standards promulgated by the pharmaceutical supervisory
and administrative department under the State Council shall be the State pharmaceutical standards.
The Pharmacopoeia Committee organized by the pharmaceutical supervisory and administrative department under the State Council shall
be responsible for the formulation and revision of the State pharmaceutical standards. The pharmaceutical inspection institutions
of the pharmaceutical supervisory and administrative department under the State Council shall be responsible for the designation
of State standard and contrastive pharmaceuticals.
Article 33
The pharmaceutical supervisory and administrative department under the State Council may organize pharmaceutical, medicinal and other
technological personnel to carry out examination and evaluation of new medicines, and to reevaluate medicines already placed into
production.
Article 34
Pharmaceutical producing enterprises, pharmaceutical trading enterprises and medical organizations must purchase pharmaceuticals from
the qualified enterprises with the certificates for production and trade of pharmaceuticals. However, this does not apply to the
purchase of the traditional Chinese medicinal herbs which are not controlled under the registered document of approval.
Article 35
For narcotics, psychotropic substances, toxic drugs for medicinal use, and radioactive drugs, the State Council shall formulate administrative
measures to carry out special control.
Article 36
The State Council shall formulate detailed measures to carry out a protection system for the categorization of traditional Chinese
medicines.
Article 37
The State Council shall formulate detailed measures to carry out a classified control system for prescription pharmaceuticals and
non-prescription pharmaceuticals.
Article 38
Import of medicines whose curative effects are uncertain or poor, or which produce adverse reactions or have other harmful effects
on people’s health shall be prohibited.
Article 39
The import of medicines must go through examinations organized by the pharmaceutical supervisory and administrative department under
the State Council. Those confirmed to conform to quality standards to be safe and effective can be approved to be imported and shall
be issued a registered certificate for import.
Medicines to be imported in small quantities for urgent clinical needs by medical organizations or for personal use shall go through
import formalities according to relevant regulations of the State.
Article 40
Pharmaceuticals must be imported through the ports which allow the import of pharmaceuticals, and the pharmaceutical import enterprise
shall submit a report to the pharmaceutical supervisory and administrative department of the place where the port is located. Customs
shall rely on the Import Pharmaceuticals Customs Form issued by the pharmaceutical supervisory and administrative department to proceed.
Those without the Import Pharmaceuticals Customs Form shall not be permitted to pass through customs.
The pharmaceutical supervisory and administrative department of the place where the port is located shall notify the pharmaceutical
inspection institution to carry out selective examinations and inspections on the imported pharmaceuticals according to the regulations
stipulated by the pharmaceutical supervisory and administrative department under the State Council, and to collect inspection fees
according to Article 41 (2) of this Law.
The nomination of the ports allowable for import of pharmaceuticals shall be jointly conducted by the pharmaceutical supervisory and
administrative department under the State Council and the Customs Headquarters, and be reported to the State Council for approval.
Article 41
The pharmaceutical supervisory and administrative department under the State Council shall appoint inspection institutions to carry
out inspections before the sale and import of the following pharmaceuticals. Those having not passed the inspection shall not be
allowed to be sold or imported.
(1)
Bio-products prescribed by the pharmaceutical supervisory and administrative department of the State Council.
(2)
Pharmaceuticals to be sold for the first time in China.
(3)
Other pharmaceuticals prescribed by the State Council.
The inspection fee and charge standards for the above-mentioned pharmaceuticals shall be jointly checked, ratified and promulgated
by the financial department under the State Council and the competent authority of price control under the State Council. The measures
for the collection of inspection fees shall be jointly formulated by the financial department under the State Council and the pharmaceutical
supervisory and administrative department under the State Council.
Article 42
The pharmaceutical supervisory and administrative department under the State Council shall organize investigations on medicines which
have been approved for production or import. It shall revoke the registered documents of approval or the registered certificate of
import if it discovers that the curative effects of the medicines are uncertain or poor, that they produce serious adverse reactions,
or that for other reasons they are harmful to people’s health.
The medicines whose registered documents of approval or registered certificate of import have been revoked shall not be allowed to
be produced, imported, sold or used. Those which have already been produced or imported shall be destroyed or disposed of under the
supervision of the local pharmaceutical supervisory and administrative departments.
Article 43
A pharmaceutical reserve system shall be carried out by the State.
In case of serious disasters, plagues and other sudden emergencies, the department prescribed by the State Council can requisite the
pharmaceuticals of enterprises to deal with such emergencies.
Article 44
The State Council shall have the power to restrict or prohibit the export of the pharmaceuticals which are in short supply in the
domestic market.
Article 45
Import or export licenses issued by the pharmaceutical supervisory and administrative department under the State Council are required
for the import or export of narcotics and psychotropic substances falling within the restricted scope prescribed by the State.
Article 46
Newly discovered domestic medicinal plants or medicinal plants introduced from abroad may be sold only after they have been examined
and approved by the pharmaceutical supervisory and administrative department under the State Council.
Article 47
Measures for controlling medicinal materials traditionally used by local people in certain regions shall be jointly formulated by
the pharmaceutical supervisory and administrative department under the State Council and the administrative department of traditional
Chinese medicines under the State Council.
Article 48
The production (including preparation, which also applies to the following) and sale of fake medicines are prohibited. A fake medicine
has any one of the following characteristics:
(1)
Its components are different from those prescribed by state pharmaceutical standards.
(2)
A non-medical substance is passed off as a medicine, or one medicine is passed off as another.
A medicine shall be handled as fake medicine in any of the following cases:
(1)
Where the use of the medicine has been prohibited by the pharmaceutical supervisory and administrative department under the State
Council;
(2)
Where the medicine is produced and imported without an approval dictated according to this Law, or the medicine is sold without being
inspected as dictated according to this Law;
(3)
Where the medicine has deteriorated; or
(4)
Where the medicine has been contaminated;
(5)
Where the medicine has been produced with pharmaceutical materials without obtaining the dictated registration document of approval
for the materials.
(6)
Where the indications or the functions marked on the labels of the pharmaceuticals do not fall within the prescribed scope.
Article 49
It is prohibited to produce and sell medicines of inferior quality, referring to the medicines whose components do not conform in
quantity to that required by State pharmaceutical standards. A medicine shall be handled as medicine of inferior quality in any of
the following cases:
(1)
An expiry date is not indicated or is altered; or
(2)
A registration number is not indicated or is altered; or
(3)
The medicine has passed its expiration date; or
(4)
The packages and containers which have direct contact with pharmaceuticals have not obtained approval; or
(5)
The medicine has been added presumptuously with color or preservative additives, spice, disguising odor or supplementary materials;
or
(6)
The medicine fails to meet the prescribed standards in other respects.
Article 50
The names of the pharmaceuticals listed in the State pharmaceutical standards are the generic names of the pharmaceuticals. Those
names that have become the generic names of pharmaceuticals shall not be used as trademarks of pharmaceuticals.
Article 51
Personnel in pharmaceutical producing or trading enterprises and in medical organizations who have direct contact with medicines must
undergo an annual medical examination. Persons who have contracted contagious diseases or any other disease which may contaminate
the medicine shall not be allowed to engage in any work which has direct contact with pharmaceuticals.
Chapter VI Administration on Pharmaceutical Packaging
Article 52
The pharmaceutical packaging materials and containers which have direct contact with pharmaceuticals must meet the requirements of
medicinal use, conform with the standards of protecting people’s health and safety, and obtain the approval of the pharmaceutical
supervisory and administrative departments at the same time as the approval of the pharmaceutical product.
Pharmaceutical producing enterprises shall use the packaging materials and containers which have direct contact with the pharmaceuticals
only after they have obtained approval for them.
The pharmaceutical supervisory and administrative departments shall stop the use of those unqualified packaging materials and containers
which have direct contact with the pharmaceuticals.
Article 53
Packaging must meet the specific quality requirements of the pharmaceuticals and facilitate their storage, transportation and medical
use.
Traditional Chinese medicinal materials must be packaged before transportation. There must appear on the package the name of the medicine,
place of production, date, name of the consignor, and an indication showing that the quality of the medicine meets standards.
Article 54
Packages of pharmaceuticals must be labeled and include directions for use in accordance with the regulations.
The label or directions must indicate the generic name of the medicine, components, specifications, the producer, registration number,
batch number of the product, production date, expiry date, indications or major functions, directions for use, dosage, restrictions,
adverse reactions and precautions.
Special indications must be printed as required on the labels of narcotics, psychotropic substances, toxic drugs for medical use,
radioactive drugs, medicines for external use and non-prescriptive pharmaceuticals.
Chapter VII Administration of the Prices and Advertising of Pharmaceuticals
Article 55
For pharmaceuticals controlled by the fixed and directive pricing system of the government, the competent authority of pricing of
the government shall fix and adjust the price with reason in conformity with the principles for fixing prices as prescribed by the
Price Law of the PRC and according to the considerations of societal average costs, market supply and demand, and the level of societal
tolerance to achieve acco
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Law of the People’s Republic of China on Regional National Autonomy
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(Adopted at the Second Session of the Sixth National People’s Congress on May 31, 1984 and promulgated by Order No.13
of the President of the People’s Republic of China on May 31, 1984; amended in accordance with the Decision on the Amending the Law
of the People’s Republic of China on Regional National Autonomy made at the 20th Meeting of the Standing Committee of the Ninth National
People’s Congress on February 28, 2001)
Contents
Preface
Chapter I General Provisions
Chapter II Establishment of National Autonomous Areas and the Structure of the Organs of Self-Government
Chapter III The Power of Autonomy of the Organs of Self-Government
Chapter IV The People’s Courts and People’s Procuratorates of National Autonomous Areas
Chapter V Relations Among Nationalities Within a National Autonomous Area
Chapter VI Responsibilities of State Organs at Higher Levels
Chapter VII Supplementary Provisions
Preface
The People’s Republic of China is a unitary multinational State created jointly by the people of all its nationalities. Regional
national autonomy is the basic policy adopted by the Communist Party of China for the solution of the national question in China
through its application of Marxism-Leninism; it is a basic political system of the State.
Regional national autonomy means that the minority nationalities, under unified State leadership, practise regional autonomy in areas
where they live in concentrated communities and set up organs of self-government for the exercise of the power of autonomy.
Regional national autonomy embodies the State’s full respect for and guarantee of the right of the minority nationalities to administer
their internal affairs and its adherence to the principle of equality, unity and common prosperity for all the nationalities.
Regional national autonomy has played an enormous role in giving full play to the initiative of all the nationalities as masters
of the country, in developing among them a socialist relationship of equality, unity and mutual assistance, in consolidating the
unification of the country and in promoting socialist construction in the national autonomous areas and the rest of the country.
In the years to come, continued efforts shall be made to uphold and improve the system of regional national autonomy, so that it
will play a greater role in the country’s socialist modernization drive.
It has been proven by practice that adherence to regional national autonomy requires that the national autonomous areas be given
effective guarantees for implementing State laws and policies in the light of existing local conditions; that large numbers of cadres
at various levels and specialized personnel and skilled workers of various professions and trades be trained from among the minority
nationalities; that the national autonomous areas strive to promote local socialist construction in the spirit of self-reliance and
hard work and contribute to the nation’s construction as a whole; and that the State strive to help the national autonomous areas
speed up their economic and cultural development in accordance with the plans for national economic and social development.
In the effort to maintain the unity of the nationalities, both big-nation chauvinism, mainly Han chauvinism, and local national chauvinism
must be opposed.
Under the leadership of the Communist Party of China and the guidance of Marxism-Leninism, Mao Zedong Thought and Deng Xiaoping Theory,
the people of various nationalities in the autonomous areas shall, together with the people of the whole country, adhere to the people’s
democratic dictatorship and to the policy of reform and opening to the outside world, march along the road of constructing socialism
with Chinese characteristics, concentrate their efforts on the socialist modernization drive, develop the socialist market economy,
foster the development of socialist democracy and the socialist legal system, enhance socialist cultural and ideological progress,
speed up the economic and cultural development of the national autonomous areas, work towards their unity and prosperity and strive
for the common prosperity of all the nationalities and for the transformation of China into a prosperous, powerful, democratic and
culturally advanced socialist country.
The “Law of the People’s Republic of China on Regional National Autonomy” is the basic law for the implementation of the system of
regional national autonomy prescribed in the Constitution.
Chapter I
General Provisions
Article 1 The Law of the People’s Republic of China on Regional National Autonomy is formulated in accordance with the Constitution
of the People’s Republic of China.
Article 2 -Regional autonomy shall be practiced in areas where minority nationalities live in concentrated communities.
National autonomous areas shall be classified into autonomous regions, autonomous prefectures and autonomous counties.
All national autonomous areas are integral parts of the People’s Republic of China.
Article 3 Organs of self-government shall be established in national autonomous areas as local organs of the State power at a particular
level.
The organs of self-government of national autonomous areas shall apply the principle of democratic centralism.
Article 4 The organs of self-government of national autonomous areas shall exercise the functions and powers of local organs of the
State as specified in Section 5 of Chapter III of the Constitution. At the same time, they shall exercise the power of autonomy
within the limits of their authority as prescribed by the Constitution, by this Law and other laws, and implement the laws and policies
of the State in the light of existing local conditions.
The organs of self-government of autonomous prefectures shall exercise the functions and powers of local State organs over cities
divided into districts and cities with counties under their jurisdiction and, at the same time, exercise the power of autonomy.
Article 5 The organs of self-government of national autonomous areas must uphold the unity of the country and guarantee that the
Constitution and other laws are observed and implemented in these areas.
Article 6 The organs of self-government of national autonomous areas shall lead the people of the various nationalities in a concentrated
effort to promote socialist modernization.
On the principle of not contravening the Constitution and the laws, the organs of self-government of national autonomous areas shall
have the power to adopt special policies and flexible measures in the light of local conditions to speed up the economic and cultural
development of these areas.
Under the guidance of State plans and on the basis of actual conditions, the organs of self-government of national autonomous areas
shall steadily increase labor productivity and economic results, develop social productive forces and gradually raise the material
living standards of the people of the various nationalities.
The organs of self-government of national autonomous areas shall inherit and carry forward the fine traditions of national cultures,
build a socialist society with an advanced culture and ideology and with national characteristics, and steadily raise the socialist
consciousness and scientific and cultural levels of the people of the various nationalities.
Article 7 The organs of self-government of national autonomous areas shall place the interests of the State as a whole above anything
else and make positive efforts to fulfill the tasks assigned by State organs at higher levels.
Article 8 State organs at higher levels shall guarantee the exercise of the power of autonomy by the organs of self-government of
national autonomous areas and shall, in accordance with the characteristics and needs of these areas, strive to help them speed up
their socialist construction.
Article 9 State organs at higher levels and the organs of self-government of national autonomous areas shall uphold and develop the
socialist relationship of equality, unity and mutual assistance among all of China’s nationalities. Discrimination against
and oppression of any nationality shall be prohibited; any act that undermines the unity of the nationalities or instigates national
division shall also be prohibited.
Article 10 The organs of self-government of national autonomous areas shall guarantee the freedom of the nationalities in these areas
to use and develop their own spoken and written languages and their freedom to preserve or reform their own folkways and customs.
Article 11 The organs of self-government of national autonomous areas shall guarantee the freedom of religious belief to citizens
of the various nationalities.
No State organ, public organization or individual may compel citizens to believe in, or not to believe in, any religion, nor may
they discriminate against citizens who believe in, or do not believe in, any religion.
The State shall protect normal religious activities.
No one may make use of religion to engage in activities that disrupt public order, impair the health of citizens or interfere with
the educational system of the State.
Religious bodies and religious affairs shall not be subject to any foreign domination.
Chapter II
Establishment of National Autonomous Areas
and the Structure of the Organs of Self-government
Article 12 Autonomous areas may be established where one or more minority nationalities live in concentrated communities, in the
light of local conditions such as the relationship among the various nationalities and the level of economic development, and with
due consideration for historical background.
Within a national autonomous area, appropriate autonomous areas or nationality townships may be established where other minority
nationalities live in concentrated communities.
Some residential areas and towns of the Han nationality or other nationalities may be included in a national autonomous area in consideration
of actual local conditions.
Article 13 With the exception of special cases, the name of a national autonomous area shall be composed of the name of the locality
and the name of the nationality and the administrative status, in that order.
Article 14 The establishment of a national autonomous area, the delineation of its boundaries and the elements of its name shall
be proposed by the State organ at the nest higher level jointly with the State organ in the relevant locality, after full consultation
with representatives of the relevant nationalities, before they are submitted for approval according to the procedures prescribed
by law.
Once established, no national autonomous area may, without legal procedures, be abolished or merged. Once defined, no boundaries
of a national autonomous area may, without legal procedures, be altered. Where abolition or merger or alteration is really required,
it shall be proposed by the relevant department of the State organ at the next higher level after full consultation with the organ
of self-government of the national autonomous area before it is submitted for approval according to legal procedures.
Article 15 The organs of self-government of national autonomous areas shall be the people’s congresses and people’s governments of
autonomous regions, autonomous prefectures and autonomous counties.
The people’s governments of national autonomous areas shall be responsible to and report on their work to the people’s congresses
at corresponding levels and to the administrative organs of the State at the next higher level. When the people’s congresses
at corresponding levels are not in session, they shall be responsible to and report on their work to the standing committees of these
people’s congresses. The people’s governments of all national autonomous areas shall be administrative organs of the State
under the unified leadership of the State Council and shall be subordinate to it.
The organization and work of the organs of self-government of national autonomous areas shall be specified in these areas’ regulations
on the exercise of autonomy or separate regulations, in accordance with the Constitution and other laws.
Article 16 In the people’s congress of a national autonomous area, in addition to the deputies from the nationality exercising regional
autonomy in the administrative area, the other nationalities inhabiting the area are also enpost_titled to appropriate representation.
The number and proportion of deputies to the people’s congress of a national autonomous area from the nationality exercising regional
autonomy and from the other minority nationalities shall be decided upon by the standing committee of the people’s congress of a
province, an autonomous region or a municipality directly under the Central Government, in accordance with the principles prescribed
by law, and shall be reported to the Standing Committee of the National People’s Congress for the record.
Among the chairman and vice-chairmen of the standing committee of the people’s congress of a national autonomous area shall be one
or more citizens of the nationality exercising regional autonomy in the area.
Article 17 The chairman of an autonomous region, the prefect of an autonomous prefecture or the head of an autonomous county shall
be a citizen of the nationality exercising regional autonomy in the area concerned. Other posts in the people’s government
of an autonomous region, an autonomous prefecture or an autonomous county shall rationally be assumed by people of the nationality
exercising regional autonomy and of other minority nationalities in the area concerned.
The people’s governments of national autonomous areas shall apply the system of giving overall responsibility to the chairman of
an autonomous region, the prefect of an autonomous prefecture or the head of an autonomous county, who shall direct the work of the
people’s governments at their respective levels.
Article 18 The cadres in the departments under the organs of self-government of a national autonomous area shall rationally be chosen
from among citizens of the nationality exercising regional autonomy and of the other minority nationalities in the area.
Chapter III
The Power of Autonomy of
the Organs of Self-Government
Article 19 The people’s congresses of national autonomous areas shall have the power to enact regulations on the exercise of
autonomy and separate regulations in the light of the political, economic and cultural characteristics of the nationality or nationalities
in the areas concerned. The regulations on the exercise of autonomy and separate regulations of autonomous regions shall be
submitted to the Standing Committee of the National People’s Congress for approval before they go into effect. The regulations
on the exercise of autonomy and separate regulations of autonomous prefectures and autonomous counties shall be submitted to the
standing committees of the people’s congresses of provinces, autonomous regions or municipalities directly under the Central Government
for approval before they go into effect, and they shall be reported to the Standing Committee of the National People’s Congress and
the State Council for the record.
Article 20 If a resolution, decision, order or instruction of a State organ at a higher level does not suit the conditions in a national
autonomous area, the organ of self-government of the area may either implement it with certain alterations or cease implementing
it after reporting to and receiving the approval of the State organ at a higher level; the said State organ shall give a reply within
60 days from the date of receipt of the report.
Article 21 While performing its functions, the organs of self-government of a national autonomous area shall, in accordance with
the regulations on the exercise of autonomy of the area, use one or several languages commonly used in the locality; where several
commonly used languages are used for the performance of such functions, the language of the nationality exercising regional autonomy
may be used as the main language.
Article 22 In accordance with the needs of socialist construction, the organs of self-government of national autonomous areas shall
take various measures to train large numbers of cadres at different levels and various kinds of specialized personnel, including
scientists, technicians and managerial executives, as well as skilled workers from among the local nationalities, giving full play
to their roles, and shall pay attention to the training of cadres at various levels and specialized and technical personnel of various
kinds from among the women of minority nationalities.
When recruiting working staff, the organ of self-government of a national autonomous area shall give appropriate considerations to
people of the nationality exercising regional autonomy and of other minority nationalities in the area.
The organs of self-government of national autonomous areas may adopt special measures to provide preferential treatment and encouragement
to specialized personnel joining in the various kinds of construction in these areas.
Article 23 When recruiting personnel in accordance with State regulations, enterprises and institutions in national autonomous areas
shall give priority to minority nationalities and may enlist them from the population of minority nationalities in rural and pastoral
areas.
Article 24 The organs of self-government of national autonomous areas may, in accordance with the military system of the State and
practical local need and with the approval of the State Council, organized local public security forces for the maintenance of public
order.
Article 25 Under the guidance of State plans, the organs of self-government of national autonomous areas shall, in the light of local
characteristics and needs, work out the guidelines, policies and plans for economic development and independently arrange for and
administer local economic development.
Article 26 Given the prerequisite of adherence to the principles of socialism, the organs of self-government of national autonomous
areas shall, in accordance with legal stipulations and in the light of the characteristics of local economic development, rationally
readjust the relations of production and the economic structure, and work hard to develop the socialist market economy.”
The organs of self-government of national autonomous areas shall uphold the basic economic system, under which public ownership is
the mainstay and the economic sectors under different types of ownership develop together, and encourage the development of the economic
sectors under non-public ownership.
Article 27 In accordance with legal stipulations, the organs of self-government of national autonomous areas shall define the ownership
of, and the right to use, the pastures and forests within these areas.
The organs of self-government of national autonomous areas shall protect and develop grasslands and forests and make arrangements
for and encourage the planting of trees and grass. Destruction of grasslands and forests by any organization or individual
by whatever means shall be prohibited. Reclamation of land from grasslands or forests by destroying grass or trees shall
strictly be prohibited.
Article 28 In accordance with legal stipulation, the organs of self-government of national autonomous areas shall manage and protect
the natural resources of these areas.
In accordance with legal stipulations and unified State plans, the organs of self-government of national autonomous areas may give
priority to the rational exploitation and utilization of the natural resources that the local authorities are enpost_titled to develop.
Article 29 Under the guidance of State plans, the organs of self-government of national autonomous areas shall independently arrange
local capital construction projects according to their financial and material resources and other specific local conditions.
Article 30 The organs of self-government of national autonomous areas shall independently administer the enterprises and institutions
under local jurisdiction.
Article 31 In accordance with State provisions, the organs of self-government of national autonomous areas may pursue foreign economic
and trade activities and may, with the approval of the State Council, open foreign trade ports.
National autonomous areas adjoining foreign countries may develop border trade with the approval of the State Council.
While conducting economic and trade activities with foreign countries, the national autonomous areas shall enjoy preferential treatment
by the State.
Article 32 The finance of a national autonomous area constitutes a particular level of finance and is a component of State finance.
The organs of self-government of national autonomous areas shall have the power of autonomy in administering the finances of their
areas. All revenues accruing to the national autonomous areas under the financial system of the State shall be managed and
used by the organs of self-government of these areas on their own.
Under the unified national financial system, a national autonomous area shall enjoy preferential treatment by the financial department
at a higher level through the standard financial transfer payment system exercised by the State.
A national autonomous area shall, in accordance with State stipulations, lay aside a reserve fund for expenditure in its budget.
The proportion of the reserve fund in its budget shall be higher than that in the budgets of other areas.
While implementing its fiscal budget, the organ of self-government of a national autonomous area shall arrange for the use of extra
income and savings from expenditures at its own discretion.
Article 33 In accordance with the principles set by the State and in the light of local conditions, the organs of self-government
of national autonomous areas may work out supplementary provisions and concrete procedures with regard to the standards of expenditure,
the sizes of the staff and the quotas of work for their respective areas. The supplementary provisions and concrete procedures
worked out by autonomous regions shall be reported to the State Council for the record; those worked out by autonomous prefectures
and autonomous counties shall be reported to the people’s governments of the relevant provinces, autonomous regions or municipalities
directly under the Central Government for approval.
Article 34 While implementing the tax laws of the State, the organs of self-government of national autonomous areas may grant tax
exemptions or reductions for certain items of local financial income which should be encouraged or given preferential consideration
in taxation, in addition to items on which tax reduction or exemption requires unified examination and approval by the State.
The decisions of autonomous prefectures and autonomous counties on tax reduction and exemption shall be reported to the people’s
governments of the relevant provinces, autonomous regions or municipalities directly under the Central Government for approval.
Article 35 A national autonomous area may, in the light of the needs of the local economic and social development and in accordance
with the stipulations of laws, set up local commercial banks and urban and rural credit cooperative organizations.
Article 36 In accordance with the guidelines of the State on education and with the relevant stipulations of the law, the organs
of self-government of national autonomous areas shall decide on plans for the development of education in these areas, on the establishment
of various kinds of schools at different levels, and on their educational system, forms, curricula, the language used in instruction
and enrollment procedures.
Article 37 The organs of self-government of national autonomous areas shall independently develop education for the nationalities
by eliminating illiteracy, setting up various kinds of schools, spreading nine-year compulsory education, developing regular senior
secondary education and secondary vocational and technical education in various forms, and developing higher education, where possible
and necessary, so as to train specialized people from among all the minority nationalities.
The organs of self-government of national autonomous areas shall set up public primary schools and secondary schools, mainly boarding
schools and schools providing subsidies, in pastoral areas and economically underdeveloped, sparsely populated mountain areas inhabited
by minority nationalities, so as to ensure that the students at school accomplish their schooling at the compulsory education stage.
The expenses for running schools and for subsidies shall be handled by the local governments. If it is difficult for the local governments
to do so, the governments at a higher level shall give them allowances.
Schools (classes and grades) and other institutions of education where most of the students come from minority nationalities shall,
whenever possible, use textbooks in their own languages and use their languages as the media of instruction. Classes for the
teaching of Chinese (the Han language) shall, where possible, be opened for junior or senior grades of primary schools to popularize
putonghua (the common speech based on Beijing pronunciation) and standard Chinese characters.
People’s governments at various levels shall give financial support to the compilation translation and publishing of teaching materials
and publications in languages of minority nationalities.
Article 38 The organs of self-government of national autonomous areas shall independently develop literature, art, the press, publishing,
radio broadcasting, the film industry, television and other cultural undertakings in forms and with characteristics unique to the
nationalities, and increase their input in cultural undertakings, provide improved cultural facilities and speed up the development
of various cultural undertakings.
The organs of self-government of national autonomous areas shall make arrangements for the units or departments concerned and support
them in their efforts to collect, sort out, translate and publish historical and cultural books of minority nationalities and protect
the scenic spots and historical sites in their areas, their precious cultural relics and their other important historical and cultural
legacies, so as to inherit and develop their outstanding traditional culture.
Article 39 The organs of self-government on national autonomous areas shall make independent decisions on local plans for developing
science and technology and spreading knowledge of science and technology.
Article 40 The organs of self-government of national autonomous areas shall make independent decisions on plans for developing local
medical and health services and for advancing both modern medicine and the traditional medicine of the nationalities.
The organs of self-government of national autonomous areas shall see to a more effective prevention and control of contagious and
endemic diseases, provide better protection for the health of women and children, and improve medical and sanitary conditions.
Article 41 The organs of self-government of national autonomous areas shall independently develop sports, promote the traditional
sports of the nationalities and improve the physical fitness of the people of the various nationalities.
Article 42 The organs of self-government of the national autonomous areas shall strive to develop exchanges and cooperation with
other areas in education, science and technology, culture and art, public health, sports, etc.
In accordance with relevant State provisions, the organs of self-government of national autonomous regions and autonomous prefectures
may conduct exchanges with foreign countries in education, science and technology, culture and art, public health, sports, etc.
Article 43 In accordance with legal stipulations, the organs of self-government of national autonomous areas shall work out measures
for control of the transient population.
Article 44 The policy of family planning and good prenatal and postnatal care shall be carried out in national autonomous areas in
order to enhance the population quality of all the nationalities.
In accordance with legal stipulations, the organs of self-government of national autonomous areas shall, in the light of local conditions,
work out measures for family planning.
Article 45 The organs of self-government of national autonomous areas shall protect and improve the living environment and the ecological
environment and shall prevent and control pollution and other public hazards, so as to bring about the coordinated development of
population, resources and environment.
Chapter IV
The People’s Courts and People’s Procuratorates
of National Autonomous Areas
Article 46 The People’s Courts and People’s Procuratorates of national autonomous areas shall be responsible to the people’s congresses
at corresponding levels and their standing committees. The People’s Procuratorates of national autonomous areas shall also
be responsible to the People’s Procuratorates at higher levels.
The administration of justice by the People’s Courts of national autonomous areas shall be supervised by the Supreme People’s Court
and by People’s Courts at higher levels. The work of the People’s Procuratorates of national autonomous areas shall be directed
by the Supreme People’s Procuratorate and by the People’s Procuratorates at higher levels.
Members of the leadership and of the staff of the People’s Court and of the People’s Procuratorate of a national autonomous area
shall include people from the nationality exercising regional autonomy in that area.
Article 47 In the prosecution and trial of cases, the People’s Courts and People’s Procuratorates in national auto
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