[頒布方] 國務院
[頒布日期] 19890113
[實施日期] 19890113
[內容]
第一章 總 則
第一條 為了加強放射性藥品的管理，根據《中華人民共和國藥品管理法》（以下稱《藥品管理法》）的規定，制定本辦法。
第二條 放射性藥品是指用于臨床診斷或者治療的放射性核素制劑或者其標記藥物。
第三條 凡在中華人民共和國領域內進行放射性藥品的研究、生產、經營、運輸、使用、檢驗、監督管理的單位和個人都必須遵守本辦法。
第四條 衛生部主管全國放射性藥品監督管理工作。能源部主管放射性藥品生產、經營管理工作。
第二章 放射性新藥的研制、臨床研究和審批
第五條 放射性新藥是指我國首次生產的放射性藥品。藥品研制單位的放射性新藥年度研制計劃，應當報送能源部備案，并報所在地的省、自治區、直轄市衛生行政部門，經衛生行政部門匯總后，報衛生部備案。
第六條 放射性新藥的研制內容，包括工藝路線、質量標準、臨床前藥理及臨床研究。研制單位在制訂新藥工藝路線的同時，必須研究該藥的理化性能、純度（包括核素純度）及檢驗方法、藥理、毒理、動物藥代動力學、放射性比活度、劑量、劑型、穩定性等。
研制單位對放射免疫分析藥盒必須進行可測限度、范圍、待異性、準確度、精密度、穩定性等方法學的研究。
放射性新藥的分類，按新藥審批辦法的規定辦理。
第七條 研制單位研制的放射性新藥，在進行臨床試驗或者驗證前，應當向衛生部提出申請，按新藥審批辦法的規定報送資料及樣品，經衛生部審批同意后，在衛生部指定的醫院進行臨床研究。
第八條 研制單位在放射性新藥臨床研究結束后，向衛生部提出申請，經衛生部審核批準，發給新藥證書。衛生部在審核批準時，應當征求能源部的意見。
第九條 放射性新藥投入生產，需由生產單位或者取得放射性藥品生產許可證的研制單位，憑新藥證書（副本）向衛生部提出生產該藥的申請，并提供樣品，由衛生部審核發給批準文號。
第三章 放射性藥品的生產、經營和進出口
第十條 放射性藥品生產、經營企業，必須向能源部報送年度生產、經營計劃，并抄報衛生部。
第十一條 國家根據需要，對放射性藥品實行合理布局，定點生產。申請開辦放射性藥品生產、經營的企業，應征得能源部的同意后，方可按照有關規定辦理籌建手續。
第十二條 開辦放射性藥品生產、經營企業，必須具備《藥品管理法》第五條規定的條件，符合國家的放射衛生防護基本標準，并履行環境影響報告的審批手續，經能源部審查同意，衛生部審核批準后，由所在省、自治區、直轄市衛生行政部門發給《放射性藥品生產企業許可證》、《放射性藥品經營企業許可證》。無許可證的生產、經營企業，一律不準生產、銷售放射性藥品。
第十三條 《放射性藥品生產企業許可證》、《放射性藥品經營企業許可證》的有效期為五年，期滿前六個月，放射性藥品生產、經營企業應當分別向原發證的衛生行政部門重新提出申請，按第十二條審批程序批準后，換發新證。
第十四條 放射性藥品生產企業生產已有國家標準的放射性藥品，必須經衛生部征求能源部意見后審核批準，并發給批準文號。凡是改變衛生部已批準的生產工藝路線和藥品標準的，生產單位必須按原報批程序經衛生部批準后方能生產。
第十五條 放射性藥品生產、經營企業，必須配備與生產、經營放射性藥品相適應的專業技術人員。具有安全、防護和廢氣、廢物、廢水處理等設施。并建立嚴格的質量管理制度。
第十六條 放射性藥品生產、經營企業，必須建立質量檢驗機構，嚴格實行生產全過程的質量控制和檢驗。產品出廠前，須經質量檢驗。符合國家藥品標準的產品方可出廠，不符合標準的產品一律不準出廠。
經衛生部審核批準的含有短半衰期放射性核素的藥品，可以邊檢驗邊出廠，但發現質量不符合國家藥品標準時，該藥品的生產企業應當立即停止生產、銷售，并立即通知使用單位停止使用，同時報告衛生部和能源部。
第十七條 放射性藥品的生產、供銷業務由能源部統一管理。放射性藥品的生產、經營單位和醫療單位憑省、自治區、直轄市衛生行政部門發給的《放射性藥品生產企業許可證》、《放射性藥品經營企業許可證》，醫療單位憑省、自治區、直轄市公安、環保和衛生行政部門聯合發給的《放射性藥品使用許可證》，申請辦理訂貨。
第十八條 放射性藥品的進出口業務，由對外經濟貿易部指定的單位，按照國家有關對外貿易的規定辦理。
進出口放射性藥品，應當報衛生部審批同意后，方得辦理進出口手續。
進口的放射性藥品品種，必須符合我國的藥品標準或者其他藥用要求。
第十九條 進口放射性藥品，必須經中國藥品生物制品檢定所或者衛生部授權的藥品檢驗所抽樣檢驗；檢驗合格的，方準進口。
對于經衛生部審核批準的短半衰期放射性核素的藥品，在保證安全使用的情況下，可以采取邊進口檢驗，邊投入使用的辦法。進口檢驗單位發現藥品質量不符合要求時，應當立即通知使用單位停止使用，并報告衛生部和能源部。
第四章 放射性藥品的包裝和運輸
第二十條 放射性藥品的包裝必須安全實用，符合放射性藥品質量要求，具有與放射性劑量相適應的防護裝置。包裝必須分內包裝和外包裝兩部分，外包裝必須貼有商標、標簽、說明書和放射性藥品標志，內包裝必須貼有標簽。
標簽必須注明藥品品名、放射性比活度、裝量。
說明書除注明前款內容外，還須注明生產單位、批準文號、批號、主要成份、出廠日期、放射性核素半衰期、適應癥、用法、用量、禁忌癥、有效期和注意事項等。
第二十一條 放射性藥品的運輸，按國家運輸、郵政等部門制訂的有關規定執行。
嚴禁任何單位和個人隨身攜帶放射性藥品乘坐公共交通運輸工具。
第二十二條 醫療單位設置核醫學科、室（同位素室），必須配備與其醫療任務相適應的并經核醫學枝術培訓的技術人員。非核醫學專業技術人員未經培訓，不得從事放射性藥品使用工作。
第二十三條 醫療單位使用放射性藥品，必須符合國家放射性同位素衛生防護管理的有關規定。所在地的省、自治區、直轄市的公安、環保和衛生行政部門，應當根據醫療單位核醫療技術人員的水平、設備條件，核發相應等級的《放射性藥品使用許可證》，無許可證的醫療單位不得臨床使用放射性藥品。
《放射性藥品使用許可證》有效期為五年，期滿前六個月，醫療單位應當向原發證的行政部門重新提出申請，經審核批準后，換發新證。
第二十四條 持有《放射性藥品使用許可證》的醫療單位，在研究配制放射性制劑并進行臨床驗證前，應當根據放射性藥品的持點，提出該制劑的藥理、毒性等資料，由省、自治區、直轄市衛生行政部門批準，并報衛生部備案。該制劑只限本單位內使用。
第二十五條 持有《放射性藥品使用許可證》的醫療單位，必須負責對使用的放射性藥品進行臨床質量檢驗，收集藥品不良反應等項工作，并定期向所在地衛生行政部門報告。由省、自治區、直轄市衛生行政部門匯總后報衛生部。
第二十六條 放射性藥品使用后的廢物（包括患者排出物），必須按國家有關規定妥善處置。
第五章 放射性藥品標準和檢驗
第二十七條 放射性藥品的國家標準，由衛生部藥典委員會負責制定和修訂，報衛生部審批頒發。
第二十八條 放射性藥品的檢驗由中國藥品生物制品檢定所或者衛生部授權的藥品檢驗所承擔。
第六章 附 則
第二十九條 對違反本辦法規定的單位或者個人，由縣以上衛生行政部門，按照《藥
品管理法》和有關法規的規定處罰。
第三十條 本辦法由衛生部負責解釋。
第三十一條 本辦法自發布之日起施行。
MEASURES FOR THE CONTROL OF RADIOACTIVE DRUGS
Important Notice: (注意事項)
英文本源自中華人民共和國務院法制局編譯, 中國法制出版社出版的《中華人民共和國涉外法規匯編》(1991年7月版).
當發生歧意時, 應以法律法規頒布單位發布的中文原文為準.
This English document is coming from the "LAWS AND REGULATIONS OF THE PEOPLE’S REPUBLIC OF CHINA GOVERNING FOREIGN-RELATED MATTERS" (1991.7) which is compiled by the Brueau of Legislative Affairs of the State Council of the People’s Republic of China, and is published by the China Legal System Publishing House.
In case of discrepancy, the original version in Chinese shall prevail.
Whole Document (法規全文)
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)
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 Cli- nical 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 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. New kinds of radioactive drugs shall be classified in accordance with the provisions for the examination and approval of new pharmaceuticals.
Article 7
Before the newly developed radioactive drug is put to clinical 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. The newly developed radioactive drug may be used for clinical study at an appointed hospital only after its application has been examined and approved by the Ministry of Public Health.
Article 8
After completion of clinical study of a newly developed radioactive drug, the research unit must submit an application to the Ministry of Public Health for examination and approval. The latter shall consult the Ministry of Energy before granting a New Drug
License.
Article 9
Before a newly developed radioactive drug is put to production, 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 Radio- active Drugs
Article 10
The enterprises that produce or sell radioactive drugs are required to submit their production plan and business plan to the Ministry of Energy and a duplicate to the Ministry of Public Health.
Article 11
The State shall, according to the actual conditions, make sure 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.
Article 12
Requirements for the setting up of enterprises to produce or 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.
Article 13
The term of validity of "License for the Production 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.
Article 14
Before an approved pharmaceutical enterprise produces 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.
Article 15
The production and business enterprises of radioactive drugs 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.
Article 16
The production and business enterprises of radioactive drugs are required to set up quality inspection offices. The entire process of production must be put under strict qualify control and inspection. All radioactive drugs are subject to quality testing. Only the products 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. As for the drugs with short half-life
radionuclide previously approved by 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.
Article 17
The production, supply and sale of radioactive drugs are under the unified administration of the Ministry of Energy. When ordering these stuff, the pharmaceutical factory must furnish a License for the Production Enterprise of Radioactive Drugs while the business unit must present a License for the usiness 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.
Article 18
The import and export business of radioactive drugs shall be 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.
Article 19
Imported radioactive drugs are subject to sample examination 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. As for the drugs with short half-life radionuclide previously approved by 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
Article 20
The packaging of radioactive drugs must be safe and reliable, 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.
The specifications must indicate the name of the producer, license number, 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, radioapecific activity and packings.
Article 21
The shipment of radioactive drugs shall be handled in 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
Article 22
If a medical treatment unit desires to set up a radiologic 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.
Article 23
When a medical treatment unit uses radioactive drugs, it must 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. The term of validity of a License for the Use of Radioactive Drugs is 5 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.
Article 24
Before a medical treatment unit holding a License for the Use 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.
Article 25
The medical treatment units that hold a License for the Use of 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.
Article 26
Waste material of radioactive drugs (including patients’ excrement) must
be properly disposed of in accordance with the State regulations.
Chapter VI The Standards for Radioactive Drugs and Their Testing
Article 27
The Pharmacopoeia Commission under the Ministry of Public 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.
Article 28
The State Administration for the Inspection and Testing of 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
Article 29
Any unit or individual that violates these Measures shall be penalized by the health administration department at or above the county level in accordance with the Pharmaceutical Administration Law and other rules and regulations.
Article 30
The right to interpret these Measures resides in the Ministry of Public Health.
Article 31
These Measures shall go into effect as of the date of promulgation.