Laws of the People's Republic of China

LAW OF THE PEOPLE'S REPUBLIC OF CHINA ON THE
ADMINISTRATION OF DRUGS

  (Adopted on September 20, 1984 at the 7th Session of
the Standing Committee of the 6th NationalPeople's Congress.)

 

 

 

SUBJECT: PHARMACEUTICS & HEALTH

ISSUING-DEPT: STANDING COMMITTEE OF PEOPLE'S CONGRESS

ISSUE-DATE: 09/20/1984

IMPLEMENT-DATE: 07/01/1985

LENGTH: 4654 words

TEXT:

CHAPTER I GENERAL PROVISIONS

[Article 1] This law has been drawn up in order to strengthen drug control and administration, ensure the quality of drugs, enhance the efficacy of drugs, guarantee safe drug use and safeguard the physical health of the people.

[Article 2] The State Council department responsible for health administration is the body in charge of national drug control and administration.

[Article 3] The State develops both modern medicines and traditional medicines, and fully utilises them in the prevention and treatment of disease, as well as in health care.¸¸ The State safeguards resources of uncultivated medicinal materials and encourages the cultivation of raw materials used for traditional Chinese medicines.

CHAPTER II ADMINISTRATION OF DRUG-PRODUCING ENTERPRISES

[Article 4] The establishment of a drug-producing enterprise must be examined and agreed to by the department in charge of drug production and handling in the province, autonomous region or municipality under the direct control of the Central Government in which the enterprise is located.¸¸ It shall be subject to examination and approval by the department responsible for health administration in the province, autonomous region or municipality under the direct control of the Central Government, which shall issue the "Drug-production Enterprise Licence".¸¸ Without a "Drug-production Enterprise Licence", the department administering industry and commerce may not issue a "Business Licence".

The "Drug-production Enterprise Licence" shall stipulate its period of validity, and at the expiry of the period the issue of the licence shall be examined afresh.¸¸ Specific procedures will be determined by the State Council department responsible for health administration.

[Article 5] The establishment of an enterprise to produce drugs must satisfy the following conditions:

(1) It must employ pharmacists, technical personnel above the rank of assistant engineer and technical workers appropriate to the drug production carried out by the enterprise.¸¸ Where an enterprise engaged in the processing of traditional Chinese medicine does not have a pharmacist or technical personnel of a rank above that of assistant engineer, it may use drug industry personnel with an intimate knowledge of drugs who have been examined and registered by a department of health administration above the county level.

(2) It must have a factory building, facilities and a hygienic environment appropriate to its production of drugs.

(3) It must have an organisation or personnel capable of carrying out quality examinations on the drugs produced as well as the necessary instruments and equipment.

[Article 6] The production of drugs must be carried out in accordance with the correct technological procedures; production records shall be kept in detail and accurately.

The preparation of Chinese medicines shall be in accordance with the "Pharmacopoeia of the People's Republic of China", or in accordance with the "Preparation Standards" laid down by the department administering health in that province, autonomous region or municipality under the direct control of the Central Government.

[Article 7] Raw materials and supplementary materials required for the production of drugs as well as containers and packing materials which come into direct contact with drugs shall meet standards required for pharmaceutical use.

[Article 8] Before drugs leave the factory, they must pass a quality examination.¸¸ If they do not reach the required standard, they must not leave the factory.

[Article 9] Drug-producing enterprises must formulate and implement a system of rules and regulations and hygiene requirements to guarantee the quality of drugs in accordance with the requirements of the "Standards for the Administration of Drug-production Quality" laid down by the department of the State Council administering health.

CHAPTER III ADMINISTRATION OF DRUG-HANDLING ENTERPRISES

[Article 10] The establishment of a drug-handling enterprise must be examined and agreed to by the department responsible for drug production and handling in the place where the enterprise is situated, and must be examined and approved by a health department at county level or above, which will issue a "Drug-handling Enterprise Licence", without which the department administering industry and commerce may not issue a "Business Licence".

A "Drug-handling Enterprise Licence" shall stipulate its period of validity, and at the expiry of the period the issue of the licence shall be examined afresh.¸¸ Specific procedures will be determined by the department of the State Council administering health.

[Article 11] The establishment of a drug-handling enterprise must satisfy the following conditions:

(1) It must employ pharmaceutical technicians appropriate to the medicines handled.

Where an enterprise engaged in the handling of Chinese medicines or partly engaged in handling drugs does not have a pharmaceutical technician it may use drug industry personnel with an intimate knowledge of the medicinal nature of the drugs handled who have been examined and registered by a department administering health at above county level.

(2) It must have business premises, equipment, storage facilities and a hygienic environment appropriate to the drugs handled.

[Article 12] On purchasing drugs, quality examinations must be carried out; if the drugs do not come up to standard, they may not be purchased.

[Article 13] In selling drugs, it is necessary to be exact and accurate; the method of use, dosage and points to note must be explained precisely.¸¸ In making up prescriptions, checks must be carried out; the drugs itemised in the prescription must not be altered or substituted without authorisation.¸¸ Where a prescription contains ingredients that are incompatible or amounts of ingredients in excess of the proper dosage, a request to make up the prescription shall be refused; if necessary, after the prescribing doctor has corrected it and signed it again, it may be made up.

Where authentic Chinese medicines are sold, they shall be labelled to indicate the place of origin.

[Article 14] Drug warehouses shall lay down and implement a system of rules and regulations for the storage of drugs and take measures necessary in relation to cold storage, protection against damp, and protection from insects, rodents, etc.

An inspection system shall be put into effect in relation to drugs which are brought into or removed from the warehouse.

[Article 15] Chinese medicinal materials may be sold in town and country trading markets except where otherwise stipulated by the State.

Drugs other than Chinese medicinal materials may not be sold in the trading markets of country towns, unless a "Drug-handling Enterprise Licence" is held.

CHAPTER IV ADMINISTRATION OF DRUGS IN MEDICAL TREATMENT UNITS

[Article 16] Medical treatment units must be staffed with the number of pharmaceutical technicians appropriate to their medical treatment responsibilities.¸¸ Personnel who are not pharmaceutical technicians may not be engaged directly in pharmaceutical technical work.

[Article 17] The making up of drugs by medical treatment units must be examined and approved by the department in charge of health administration in the province, autonomous region or municipality under the direct control of the Central Government where the unit is situated, which will issue a "Dispensing Licence".

A "Dispensing Licence" shall stipulate its period of validity, and at the expiry of the period the issue of the licence shall be examined afresh.¸¸ Specific procedures will be laid down by the department of the State Council administering health.

[Article 18] A medical treatment unit which makes up drugs must have adequate facilities, instruments for examination and hygienic conditions to ensure the quality of the drugs prepared.

[Article 19] The drugs made up by medical treatment units must comply with clinical requirements and, in accordance with regulations, quality examinations must be conducted.¸¸ They are only to be used if up to quality and on a doctor's prescription.¸¸ Drugs made up by medical treatment units may not be sold on the market.

[Article 20] When a medical treatment unit purchases drugs, it must implement a system of checking the quality on delivery.

CHAPTER V DRUG ADMINISTRATION

[Article 21] The State encourages research into and development of new drugs.

Where a new drug has been researched and developed, in accordance with the regulations, a report must be submitted, with samples, to the State Council department administering health or the department of the province, autonomous region or municipality under the direct control of the Central Government administering health, giving details of the method of research and development, quality norms, pharmacological and toxicological tests and other relevant data.¸¸ Only after it has been approved may clinical tests or clinical verifications be carried out.

Where a new drug has completed its clinical tests or clinical verification and has passed an appraisal it may be approved by the department of the State Council administering health, which will issue a certificate.

[Article 22] The production of new drugs must be approved by the department of the State Council administering health which will issue an approval number.¸¸ However, the production of Chinese medicines sliced and prepared for decoction is excepted.

The production of drugs for which there is already a national drug standard, or a drug standard of a province, autonomous region or municipality under the direct control of the Central Government, must be examined and approved by the department responsible for health administration in the relevant province, autonomous region or municipality under the direct control of the Central Government after seeking the opinion of the corresponding authority responsible for the drug-producing enterprise.¸¸ An approval number will be issued.¸¸ However, the production of Chinese medicines sliced and prepared for decoction is excepted.

[Article 23] Drugs must comply with the national drug standard, or with the drug standard of the province, autonomous region or municipality under the direct control of the Central Government.

The "Pharmacopoeia of the People's Republic of China" and drug standards promulgated by the department of the State Council administering health are the national drug standards.

The Pharmacopoeia Committee of the department of the State Council administering health is the body responsible for handling the setting and revision of national drug standards.

[Article 24] The State Council department responsible for health administration and the departments of the provinces, autonomous regions and municipalities under the direct control of the Central Government administering health may establish a Drug Evaluation Committee to evaluate new drugs and re-evaluate drugs already being produced.

[Article 25] The department of the State Council responsible for administering health shall organise investigation into drugs already approved for production; where the efficacy of a drug is not reliable, the side-effects to a drug are great, or a drug is for any other reason harmful to people's health, the approval number shall be revoked.

Where the approval number of a drug has been revoked, production and sale of the drug may not be continued; what has already been produced shall be burnt or disposed of under the supervision of the local department administering health.

[Article 26] It is forbidden to import a drug if its efficacy is not reliable, if its side-effects are great, or it is for any other reason harmful to people's health.

[Article 27] Where a drug is being imported for the first time, the importing unit must submit a written description of the drug, details of its quality standards, testing and other relevant data, samples, and documentation proving that the exporting country (place) has approved production.¸¸ Only when the approval of the department of the State Council administering health has been obtained may the import contract be signed.

[Article 28] Imported drugs must be examined by a drug examination body so authorised by the State Council department responsible for health administration.¸¸ Only when a drug passes examination will importation be permitted.

The importation of a small amount of a drug to meet the urgent clinical needs of a medical treatment unit or for the personal use of an individual is to follow the importation procedures stipulated by Customs.

[Article 29] Where the supply of Chinese medicinal materials or prepared Chinese medicine is not sufficient for the Chinese domestic market, the State Council department responsible for health administration has the power to restrict or prohibit its export.

[Article 30] In order to import or export narcotic drugs or psychotropic drugs which come within the scope laid down by the department of the State Council administering health, it is necessary to hold an "Import Licence" or "Export Licence" issued by the department of the State Council administering health.

[Article 31] Medicinal materials which have been newly discovered or introduced from abroad may only be sold where they have been examined and approved by the department of the province, autonomous region or municipality under the direct control of the Central Government administering health.

[Article 32] Detailed provisions for the administration of local customarily used folk medicines will be laid down by the State Council department responsible for health administration.

[Article 33] The production and sale of spurious drugs is prohibited.¸¸ A drug is spurious if any one of the following circumstances exists:

(1) The names of the ingredients contained in the drug do not correspond to the national drug standard or the drug standard set by the province, autonomous region or municipality under the direct control of the Central Government;

(2) A substance that is not a drug is passed off as a drug, or one sort of drug is passed off as another drug.

A drug will be treated as a spurious drug if one of the following circumstances exists:

(1) The State Council department responsible for health administration has stipulated that its use is forbidden;

(2) It was produced without first obtaining an approval number;

(3) Due to deterioration, it cannot be used for medicinal purposes;

(4) Due to contamination, it cannot be used for medicinal purposes.

[Article 34] It is forbidden to produce or sell inferior drugs.¸¸ A drug is inferior if one of the following circumstances exists:

(1) The content of its ingredients does not comply with the national drug standard or the drug standard set by the province, autonomous region or municipality under the direct control of the Central Government;

(2) Its period of efficacy has expired;

(3) It fails in any other way to comply with stipulated drug standards.

[Article 35] Personnel of drug-producing enterprises, drug-handling enterprises and medical treatment units who come into direct contact with drugs must undergo a medical examination annually.¸¸ Persons suffering from contagious diseases or any other disease that could contaminate drugs may not engage in work involving direct contact with drugs.

CHAPTER VI THE PACKAGING AND REPACKAGING OF DRUGS

[Article 36] The packaging of drugs must be appropriate to the requirements of the quality of the drug and must facilitate their storage, transportation and use.¸¸ Where a period of efficacy for a drug has been fixed, the period of efficacy must be clearly indicated on the package.

Where Chinese medicinal materials are to be transported, they must be packaged.¸¸ On each package, the name of the product, its place of origin, the date and the name of the dispatching unit must be clearly indicated and it must be marked to indicate that the quality is up to standard.

[Article 37] Drug packages must, in accordance with regulations, be labelled and have an instruction booklet attached.

The name of the drug, its specifications, the producing unit, approval number, product batch number, principal ingredients, diseases for which it is indicated, manner of use, side-effects and points to note must be clearly set out on the label or in the instruction booklet.

The labels of narcotic drugs, psychotropic drugs, poisonous drugs, radioactive drugs and drugs for external use only must bear the prescribed mark.

[Article 38] A drug-handling enterprise engaged in the repackaging of drugs must have equipment and hygienic conditions appropriate for the quantity of drugs repackaged.¸¸ It must be under the charge of pharmaceutical technicians; records of the repackaging must be complete and precise.

An instruction booklet must be attached to a repackaged drug.¸¸ The product name, specifications, name of the production unit and product batch number and of the repackaging unit and repackaging batch number shall be set out clearly on the package.¸¸ Where a period of efficacy has been set for the drug, when it has been repackaged, the period of efficacy must be clearly indicated.

CHAPTER VII DRUGS UNDER SPECIAL CONTROL

[Article 39] The State imposes special controls on narcotic drugs, psychotropic drugs, poisons and radioactive drugs.¸¸ The controls will be stipulated by the State Council.

[Article 40] The production of narcotic drugs, including the original plant, may only be undertaken by units appointed to do so by the department of the State Council administering health and relevant departments acting jointly, and supply may only be undertaken by units appointed by the department of the province, autonomous region or municipality under the direct control of the Central Government administering health and the relevant departments acting jointly.

CHAPTER VIII ADMINISTRATION OF DRUG TRADEMARKS AND ADVERTISING

[Article 41] With the exception of Chinese medicinal materials and Chinese medicines sliced and prepared for decoction, drugs must use a registered trademark and may not be sold on the market until examined and approved for registration.

The registered trademark must be clearly shown on the package and label of the drug.

[Article 42] An advertisement for a drug must be examined and approved by the department of the province, autonomous region or municipality under the direct control of the Central Government responsible for administering health; unless it is approved, it may not be published, broadcast, distributed or displayed on a poster.

[Article 43] Where a foreign enterprise applies to advertise a drug in this country, it must submit documents proving approval of the drug from the country (or place) of its production, a written description of the drug and relevant material.

[Article 44] The contents of an advertisement for a drug must be in accordance with the explanatory booklet approved by the department of the State Council administering health or the department of the province, autonomous region or municipality under the direct control of the Central Government administering health.

CHAPTER IX DRUG CONTROL

[Article 45] Departments administering health above the county level exercise the power of supervision over drugs.

Departments administering health at above county level may establish drug administration bodies and drug inspection bodies.

[Article 46] Departments administering health at above county level will appoint Drug Controllers.¸¸ Drug Controllers will be appointed from those holding the position of pharmaceutical technicians; they shall be examined, and a certificate will be issued by the People's Governments at that level.

[Article 47] A Drug Controller has the power, in accordance with regulations, to control, inspect and test the quality of drugs in drug-producing enterprises, drug-handling enterprises and medical treatment units within the Controller's area of jurisdiction.¸¸ If necessary, the Drug Controller may, in accordance with regulations, take samples and obtain relevant data which the relevant unit may not refuse to provide and may not conceal.

Drug Controllers are responsible for keeping the technical data provided by drug-manufacturing enterprises or scientific research units confidential.

[Article 48] Drug-producing enterprises, drug-handling enterprises and medical treatment units shall regularly inspect and study the quality, efficacy and side-effects of drugs produced, handled or used by them.

If a medical treatment unit discovers a case of poisoning in relation to a drug, it must immediately report it to the department administering health in that area.

[Article 49] The drug-inspection body or personnel of a drug-producing enterprise or drug-handling enterprise will receive guidance in their professional work from the drug-inspection organ of that area.

CHAPTER X LEGAL RESPONSIBILITIES

[Article 50] Where spurious drugs are produced or sold, the spurious drugs and the illegally obtained income will be confiscated and a fine will be imposed.¸¸ In addition, the relevant unit may be ordered to stop production or stop operations for rectification or its "Drug-production Enterprise Licence", "Drug-handling Enterprise Licence" or "Dispensing Licence" may be revoked.

In pursuance of the regulations of Article 164 of the Penal Code, criminal liability will be investigated and determined in relation to individuals or units directly involved in the production or sale of spurious drugs endangering the people's health.

[Article 51] Where inferior drugs are produced or sold, the inferior drugs and the illegally obtained income will be confiscated and a fine may also be imposed; if the circumstances are serious, the relevant unit may be ordered to stop production or stop its operations and rectify itself, or its "Drug-production Enterprise Licence", "Drug-handling Enterprise Licence" or "Dispensing Licence" may be revoked.

In pursuance of Article 164 of the Penal Code, criminal liability will be investigated and determined in relation to individuals or units directly involved in the production or sale of inferior drugs endangering the people's health.

[Article 52] Where drugs are manufactured, handled or made up without a "Drug-production Enterprise Licence", Drug-handling Enterprise Licence" or "Dispensing Licence", the relevant unit will be ordered to stop production, stop operations or stop preparing medications.¸¸ All of the illegally-produced drugs and the illegally-obtained income shall be confiscated and a fine may also be imposed.

[Article 53] A violation of any other provision of this law in relation to the administration of drug production or handling will be punished by a caution or by a fine.

[Article 54] Any decision relating to the imposition of an administrative penalty pursuant to this law shall be made by the department administering health at above the county level.¸¸ Any decision relating to the imposition of a penalty for and offence against Article 15 of this law or the provisions of Chapter VIII of this law with respect to the advertising of drugs, shall be made by the department administering industry and commerce.¸¸ In relation to the penalty of ordering a drug-producing enterprise or drug-handling enterprise which is directly under the management of the Central Government or the People's Government of a province, autonomous region or municipality directly under the control of the Central Government to stop production or stop its operations for more than seven days, or of revoking its "Drug-production Enterprise Licence", or "Drug-handling Enterprise Licence", the department of the province, autonomous region or municipality under the direct control of the Central Government administering health shall submit it to the People's Government at the same level for decision.

In relation to a penalty ordering a drug-producing enterprise or drug-handling enterprise under the direct management of the People's Government at or below the city or county level to stop production or stop operations for more than seven days or of revoking its "Drug-production Enterprise Licence" or its "Drug-handling Enterprise Licence", the department of the city or county People's Government administering health shall submit the matter to the People's Government of the same level for decision.

Confiscated drugs shall be disposed of under the supervision of the department responsible for health administration.

[Article 55] If a party objects to the decision to impose a penalty on him, he may, within 15 days from the date of receipt of notification of the penalty, bring an action in the People's Court.¸¸ However, in the case of a decision relating to drug control taken by the department responsible for health administration, the party shall immediately comply.¸¸ Where the decision has not been complied with within the time limit and no action has been brought, the People's Court shall compulsorily enforce compliance upon application by the organ which made the decision.

[Article 56] In case of drug poisoning caused by a breach of this law, the unit or person who caused it shall be liable to pay compensation.¸¸ The person suffering harm may request a department administering health at above county level to handle the matter; if the party who caused the harm objects, he or it may bring an action in the People's Court.¸¸ The person suffering harm may also sue directly in the People's Court.

A demand to be compensated for damage shall be submitted within a period of one year from the date on which the victim or his representative became aware or ought to have become aware of it.¸¸ When this period has expired, the claim will not be entertained.

CHAPTER XI MISCELLANEOUS

[Article 57] The expressions used in this law are defined as follows:

"Drug" refers to a substance used for the prevention, treatment and diagnosis of human diseases, and with the object of regulating human physiological functions, with stipulated indications, usage and dosage.¸¸ It includes Chinese medicinal materials and Chinese medicines sliced and prepared for decoction, prepared Chinese medicines, chemical raw material drugs and their components, antibiotics, biochemical drugs, radioactive drugs, blood serums and vaccines, blood products, diagnostic drugs and so on.

"New drugs" refers to those drugs which have never been produced in this country.

"Supplementary materials" refers to excipients and additives used in the production and making up of drugs.

"Drug-producing enterprise" refers to those enterprises exclusively or partially engaged in the production of drugs.

"Drug-handling enterprise" refers to those enterprises exclusively or partially engaged in the handling of drugs.

[Article 58] The production of drugs referred to in this law does not include the cultivation and collection of raw materials for Chinese medicines or the raising of animals in relation to Chinese medicines.

[Article 59] Measures for the implementation of this law will be set down by the State Council department responsible for health administration and submitted to the State Council for approval and implementation.

Special provisions for the management of drugs in the People's Liberation Army will be laid down by the department in charge of national military affairs.

[Article 60] This law shall come into force on July 1, 1985.