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| Category | PUBLIC HEALTH AND MEDICINE | Organ of Promulgation | The State Council | Status of Effect | In Force |
| Date of Promulgation | 1989-01-13 | Effective Date | 1989-01-13 |
|
Measures for the Control of Radioactive Drugs |
|---|
Article 1 These Measures are formulated to strengthen the control of
radioactive drugs in accordance with Pharmaceutical Administration Law of the
People's Republic of China (hereinafter referred to as the Pharmaceutical
Administration Law).
Article 2 "Radioactive drugs" refer to any forms of radionuclide or their
tagged drugs that are used for clinical diagnosis or in radiotherapy.
Article 3 All units or individuals in the People's Republic of China are
required to abide by these Measures when they are engaged in research work,
production, business, transportation, consumption, examination, supervision
and administration work related to radioactive drugs.
Article 4 The Ministry of Public Health is in charge of the supervisory Article 5 "New radioactive drugs" refer to those radioactive drugs that Article 6 The development of a new kind of radioactive drug includes the The research unit, when designing the technological process for a new New kinds of radioactive drugs shall be classified in accordance with the Article 7 Before the newly developed radioactive drug is put to clinical The newly developed radioactive drug may be used for clinical study at an Article 8 After completion of clinical study of a newly developed The latter shall consult the Ministry of Energy before granting a New Article 9 Before a newly developed radioactive drug is put to production, Article 10 The enterprises that produce or sell radioactive drugs are Article 11 The State shall, according to the actual conditions, make sure Article 12 Requirements for the setting up of enterprises to produce or Article 13 The term of validity of "License for the Production Article 14 Before an approved pharmaceutical enterprise produces Article 15 The production and business enterprises of radioactive drugs Article 16 The production and business enterprises of radioactive drugs All radioactive drugs are subject to quality testing. Only the products As for the drugs with short half-life radionuclide previously approved by Article 17 The production, supply and sale of radioactive drugs are under When ordering these stuff, the pharmaceutical factory must furnish a Article 18 The import and export business of radioactive drugs shall be Article 19 Imported radioactive drugs are subject to sample examination As for the drugs with short half-life radionuclide previously approved by Article 20 The packaging of radioactive drugs must be safe and reliable, The specifications must indicate the name of the producer, license number, Article 21 The shipment of radioactive drugs shall be handled in Article 22 If a medical treatment unit desires to set up a radiologic Article 23 When a medical treatment unit uses radioactive drugs, it must The term of validity of a License for the Use of Radioactive Drugs is 5 Article 24 Before a medical treatment unit holding a License for the Use Article 25 The medical treatment units that hold a License for the Use of Article 26 Waste material of radioactive drugs (including patients' Article 27 The Pharmacopoeia Commission under the Ministry of Public Article 28 The State Administration for the Inspection and Testing of Article 29 Any unit or individual that violates these Measures shall be Article 30 The right to interpret these Measures resides in the Ministry Article 31 These Measures shall go into effect as of the date of
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and administrative work of radioactive drugs while the Ministry of Energy is
in charge of the administration work concerning the production and sale of
radioactive drugs.
Chapter II Examination and Approval for the Development and Clinical
Research of New Radioactive Drugs
are made in China for the first time. The annual plan of any drug research
units for the development of new radioactive drugs must be submitted both to
the Ministry of Energy for the record and to the health administration
department at the provincial, autonomous regional or municipal (directly under
the Central Government) level. Then an itemized plan made by the latter shall
be presented to the Ministry of Public Health for the record.
research work in technological process, quality requirements,
preclinicopharmacological study and clinical study.
drug, must study the physical and chemical properties, purity (including
pureness of radionuclide), testing method, pharmacology, toxicity, nuclein
animal dynamics, radiospecific activity, dosage, pharmaceutical forms and
stability of that radioactive drug. Furthermore, the research unit must make a
study of radio-immunity analysis container with respect to its scalability,
range, specificity, accuracy, precision and stability.
provisions for the examination and approval of new pharmaceuticals.
test or verification, an application together with the data and sample must be
submitted to the Ministry of Public Health in accordance with the provisions
for the examination and approval of new pharmaceuticals.
appointed hospital only after its application has been examined and approved
by the Ministry of Public Health.
radioactive drug, the research unit must submit an application to the Ministry
of Public Health for examination and approval.
Drug License.
the production unit or the research unit that holds a license for the
production of radioactive drugs must submit an application together with a
copy of New Drug License and sample to the Ministry of Public Health. After
examination and verification, the Ministry of Public Health shall issue them
document of approval.
Chapter III The Production, Sales, Import and Export of Radioactive Drugs
required to submit their production plan and business plan to the Ministry of
Energy and a duplicate to the Ministry of Public Health.
that radioactive drugs be produced at designated pharmaceutical factories
which shall be located rationally over the country. Applications for the
setting up of any enterprises to produce or sell radioactive drugs must be
approved by the Ministry of Energy before the preparations start in accordance
with related provisions.
sell radioactive drugs are that they must have the necessary conditions as
stipulated in Article 5 of the Pharmaceutical Administration Law and that they
must meet the essential standard of radio hygiene protection set by the State.
They are also required to submit a report on environment impact to the
Ministry of Energy and the Ministry of Public Health for examination and
approval and then the health administration department in their province,
autonomous region or municipality directly under the Central Government shall
issue them "License for the Production Enterprise of Radioactive Drugs",
"License for the Business Enterprise of Radioactive Drugs". No enterprises
without the license shall be permitted to engage in the production or sale of
radioactive drugs.
Enterprise of Radioactive Drugs" and "License for the Business Enterprise of
Radioactive Drugs" is five years. If needed, the enterprises engaged in the
production or sale of radioactive drugs shall make a new application six
months before the expiration to the health administration department which
shall, in accordance with Article 12 of these Provisions, issue them a new
license.
radioactive drugs with specifications already set by the State, it must
forward an application which has to be examined and approved by the Ministry
of Public Health in conjunction with the Ministry of Energy. If any changes in
the technological process and specifications of the drugs previously approved
by the Ministry of Public Health are to be made, the pharmaceutical factory
shall be required to go through the same procedures for approval.
are required to employ technical personnel who are qualified for the work and
to have safety and protection facilities as well as waste gas, liquid and
material disposal facilities. They must also have a strict quality control
system.
are required to set up quality inspection offices. The entire process of
production must be put under strict qualify control and inspection.
that meet the State pharmaceutical standard shall be allowed to be shipped out
from the factories. Products that are not up to the standard are not allowed
out of the factory.
the Ministry of Public Health, they may be shipped out from the factory while
having sample testing. If the drugs are found to be below the State
pharmaceutical standard, the factory must stop the production and sale of the
drugs immediately and inform consuming units to stop using the drugs without
delay. A report about the case must be submitted to both the Ministry of
Public Health and the Ministry of Energy.
the unified administration of the Ministry of Energy.
License for the Production Enterprise of Radioactive Drugs while the business
unit must present a License for the Business Enterprise of Radioactive Drugs
issued by the health administration department at the provincial, autonomous
regional or municipal (directly under the Central Government) level. As for
the medical treatment unit, they must order these drugs with a License for the
Use of Radioactive Drugs jointly issued by the public security department, the
environment protection department and health administration department at the
provincial, autonomous regional or the municipal (directly under the Central
Government) level.
handled by the units appointed by the Ministry of Foreign Economic Relations
and Trade in accordance with the State provisions related to foreign trade.
Prior to the import or export of radioactive drugs, an application must be
made and be examined and approved by the Ministry of Public Health. Imported
radioactive drugs are required to meet the State standards for pharmaceuticals
or other medical requirements.
by the State Administration for the Inspection and Testing of Pharmaceuticals
and Biological Products or by an inspection and testing institution of
pharmaceuticals authorized by the Ministry of Public Health. Only those drugs
that have met the State standards are allowed to be imported.
the Ministry of Public Health, they may be put to use upon being shipped in
while having import inspection. If the import inspection unit finds the
quality of imported drugs not up to the standard, they must inform the
consuming units promptly to stop using the drugs. A report about the quality
problem must be submitted to both the Ministry of Public Health and the
Ministry of Energy.
Chapter IV The Packaging and Shipment of Radioactive Drugs
and up to the standards for the quality requirements of radioactive drug.
There must be protection devices that will match different radio dosages. The
packaging is required to consist of packing and inner packaging. There must be
trade mark, label, specifications and marker of radioactive drugs on the
packing and a label on the inner packaging. On the label there must be name of
the drug, radiospecific activity and packings.
batch number, main composition, date of manufacture, half-life of
radionuclide, indications, administration, dosage, contraindication, expiry
date and precautions in addition to name of the drug, radiospecific activity
and packings.
accordance with the rules formulated by the State transportation and postal
departments. No unit or person shall be allowed to carry along radioactive
drugs on any means of public transportation.
Chapter V The Use of Radioactive Drugs
department or a radioisotope department, it is required to employ technical
personnel who are qualified for radiotherapeutic work after special technical
training. Without prior technical training no personnel shall be allowed to
use the drugs in radiotherapy.
observe the rules formulated by the State concerning radioisotope hygiene and
protection. The health administration department, the public security
department and the environment protection department at provincial, autonomous
regional or municipal (directly under the Central Government) level shall
issue a certain grade of License for the Use of Radioactive Drugs according to
technical skill and professional level of the radiological personnel and
equipment of the medical treatment unit. No medical treatment unit without a
license is allowed to use radioactive drugs clinically.
years. If needed, the medical treatment unit must make a new application 6
months before the expiration of its license to the health administration
department which, after examination and verification shall issue it a new
license.
of Radioactive Drugs starts the preparation of any forms of radioactive drug
for clinical use, it is required to submit an application with the data
concerning pharmacology and toxicity of the radioactive drug, according to the
characteristics of the radioactive drug, to the health administration
department at the provincial, autonomous regional or municipal (directly under
the Central Government) level for approval and to the Ministry of Public
Health for the record. That form of radioactive drug can be used only in the
medical treatment unit.
Radioactive Drugs are required to conduct clinical quality testing of the
radioactive drugs and find out their undesirable reactions and submit regular
reports to the health administration department. The health administration
department at the provincial, autonomous regional or municipal (directly under
the Central Government) level shall then present an itemized report to the
Ministry of Public Health.
excrement) must be properly disposed of in accordance with the State
regulations.
Chapter VI The Standards for Radioactive Drugs and Their Testing
Health is entrusted to formulate and revise the State standards for
radioactive drugs and then submit it to the Ministry of Public Health for
examination and approval before it is promulgated.
Pharmaceuticals and Biological Products or an inspection and testing
institution of pharmaceuticals authorized by the Ministry of Public Health is
entrusted to inspect and examine radioactive drugs.
Chapter VII Supplementary Provisions
penalized by the health administration department at or above the county level
in accordance with the Pharmaceutical Administration Law and other rules and
regulations.
of Public Health.
promulgation.
URL: http://www.asianlii.org/cn/legis/cen/laws/mftcord428