1989.01.13
STATE COUNCIL OF CHINA
MEASURES FOR THE CONTROL OF RADIOACTIVE DRUGS
(Promulgated by Decree No. 25 of the State Council of the People's
Republic of China on January 13, 1989 and effective as of the date of
promulgation)
CONTENTS
CHAPTER I GENERAL PROVISIONS
CHAPTER II EXAMINATION AND APPROVAL FOR THE DEVELOPMENT AND
CLINICAL RESEARCH OF NEW RADIOACTIVE DRUGS
CHAPTER III THE PRODUCTION, SALES, IMPORT AND EXPORT OF RADIOACTIVE
DRUGS
CHAPTER IV THE PACKAGING AND SHIPMENT OF RADIOACTIVE DRUGS CHAPTER V
CHAPTER V THE USE OF RADIOACTIVE DRUGS
CHAPTER VI THE STANDARDS FOR RADIOACTIVE DRUGS AND THEIR TESTING
CHAPTER VII SUPPLEMENTARY PROVISIONS
CHAPTER I GENERAL PROVISIONS
@@ 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 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
@@ Article 5. "New radioactive drugs" refer to those radioactive
drugs that 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 to both 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.
@@ Article 6. The development of a new kind of radioactive drug
includes the research work in its technological process, quality
requirements, preclinicopharmacological study and clinical study;
The research unit, when designing the technological process for a new
drug, must study the physical and chemical properties, purity
(including pureness of radionuclide), testing method, pharmacology,
toxicity, nuclein ani[1] [2] [3] [4] [5] [6] 下一页
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