Commissioner of SFDA


Special Review and Approval Procedure for Drug Registration of the State Food and Drug Administration



(SFDA Decree No. 21)

The Special Review and Approval Procedure for Drug Registration of the State Food and Drug Administration, adopted at the executive meeting of the State Food and Drug Administration (SFDA) on November 18, 2005, is hereby promulgated and shall go into effect as of the date of promulgation.


Shao Mingli
Commissioner of SFDA
November 18, 2005





Special Review and Approval Procedure for Drug Registration of the State Food and
Drug Administration


Chapter 1 General Provisions

Article 1 This Procedure is formulated for the purpose of effective prevention, timely control and elimination of the hazards of public health emergencies to ensure the health and safety of the public in accordance with the Drug Administration Law of the People’s Republic of China, Law of the People’s Republic of China on the Prevention and Treatment of Infectious Diseases, Regulations for Implementation of the Drug Administration Law of the People’s Republic of China, Regulations on Preparedness for and Response to Emergent Public Health Hazards, and other relevant laws and regulations.

Article 2 The special review and approval procedure for drug registration refers to the procedure and requirements of the State Food and Drug Administration to carry out special review and approval of drugs for handling public heath emergencies under the principle of unified leadership, early involvement, expeditiousness and efficiency, and scientific review and approval, in an effort to approve drugs for the prevention and treatment of public health emergencies as soon as possible under the threat or after the occurrence of public heath emergencies.

Article 3 The State Food and Drug Administration may, according to law, decide to follow the Procedure to conduct special review and approval of drugs for public health emergencies in any of the following circumstances:
(1) Where the President of the People’s Republic of China declares a state of emergency or the State Council decides that certain areas within a province, autonomous region or municipality directly under the Central Government are in a state of emergency;
(2) Where the contingency program for public health emergencies is initiated according to law;
(3) Where the drug reserve department or the health administrative department of the State Council proposes a special review and approval for drugs having existing national drug standard;
(4) Other circumstances applicable to special review and approval.

Article 4 The State Food and Drug Administration is responsible for the review and approval of clinical trials, production and importation of drugs for the prevention and treatment of public health emergencies.

The (food and) drug regulatory department of a province, autonomous region, or municipality directly under the Central Government shall, upon entrustment of the State Food and Drug Administration, be responsible for on-site inspection and sampling of the pilot products of the drugs for the prevention and treatment of public health emergencies.


Chapter 2 Application Acceptance and On-site Inspection

Article 5 Where the special review and approval procedure for drug registration is initiated, the State Food and Drug Administration is responsible for the acceptance of registration applications for drugs for public health emergencies.

Where a drug or a preventive biological product for public health emergencies has not been marketed in China, the applicant shall, before submission of the registration application, provide the State Food and Drug Administration with relevant research and development information.

Article 6 The applicant shall submit a registration application with relevant technical dossier to the State Food and Drug Administration according to the relevant provisions and requirements on administration of drug registration.

The registration application for drug for public health emergencies may be submitted in electronic form.

Article 7 Before submitting an application for registration, the applicant may provide a feasibility assessment application with general information and relevant explanations. The State Food and Drug Administration shall only comment on the scientific rationality and feasibility of the drug project, and respond within 24 hours.

The response to a feasibility assessment application shall be neither deemed as the review and approval opinion nor legally binding on the review and approval result of a registration application.

Article 8 The State Food and Drug Administration shall organize an expert group to evaluate and review the registration application for drug for the prevention and treatment of public health emergencies, make a decision within 24 hours on whether or not to accept the application, and notify the applicant.

Article 9 Where a registration application is accepted, the State Food and Drug Administration shall organize technical review of submitted dossier within 24 hours and at the same time notify the (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government where the applicant is located to conduct an on-site inspection on drug research and development conditions, and organize sampling and testing of pilot products.

The (food and) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government shall, within five days, submit the on-site inspection result and relevant opinion to the State Food and Drug Administration.

Article 10 The (food and) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government shall organize staff from the departments of drug registration, drug safety and inspection, etc. to participate in the on-site inspection.

The National Institute for the Control of Pharmaceutical and Biological Products shall be notified to send staff to participate in the on-site inspection and sampling of preventive biological products.

Article 11 For drugs that have existing national standards for the prevention and treatment of public health emergencies, the State Food and Drug Administration may directly review and approve the drug in accordance with the relevant provisions in Chapter 6 of the Procedure when it deems there is no need for a clinical trial in accordance with law.

Article 12 With respect to the registration application for a specific vaccine, where only the original virus strain used in the manufacturing is changed while the manufacturing processes or quality specifications are maintained, the State Food and Drug Administration shall make a decision on whether or not to grant the approval within three days after verifying the changed strain used in the manufacturing.


Chapter 3 Testing for Registration

Article 13 After receiving the samples taken by the (food and) drug regulatory department of a province, autonomous region, or municipality directly under the Central Government, the drug testing institution shall immediately organize verification of specifications and laboratory testing on the samples.

The drug testing institution shall complete the testing within the time frame for the drug being applied.

Article 14 For a drug applied first time for marketing, the State Food and Drug Administration may, when necessary, make early involvement by appointing the National Institute for the Control of Pharmaceutical and Biological Products to communicate with the applicant prior to testing for registration so as to timely resolve technical problems which may arise in the process of quality specifications verification and laboratory testing.

With respect to preventive biological products used to prevent and control the epidemic of serious infectious diseases, the State Food and Drug Administration may, depending on the situation, allow the testing for registration and the manufacturer’s self-testing to be performed in parallel.

Article 15 After completion of the specifications verification and laboratory testing on a drug, the drug testing institution shall, within two days, issue its verification opinion and submit it along with the drug test report to the State Food and Drug Administration.


Chapter 4 Technical Review

Article 16 The State Food and Drug Administration shall, within 15 days after acceptance of the registration application for drug for the prevention and treatment in public health emergencies, complete the first round of technical review.

Article 17 Where the State Food and Drug Administration considers that additional data are needed, it shall immediately inform the applicant of the content and timeline.

Where the applicant submits the supplementary data within the specified timeline, the State Food and Drug Administration shall complete the technical review within three days, or, depending on the situations, organize another review meeting within five days, and then complete the review report within two days.


Chapter 5 Clinical Trial

Article 18 Where the technical review is completed, the State Food and Drug Administration shall, within three days, complete the administrative examination, make a decision and inform the applicant.

Where the State Food and Drug Administration decides to approve a clinical trial, it shall issue a Drug Clinical Trial Approval. Where it decides not to approve, it shall issue a Disapproval Notice with reasons.

Article 19 Where an applicant obtains a clinical trial approval, it shall conduct the trial strictly following the relevant requirements in the approval document, and comply with the Good Clinical Practice.

Article 20 Drug clinical trials shall be conducted in institutions legally certified for drug clinical trials. If a clinical trial has to be conducted by an institution not yet certified, a special approval by the State Food and Drug Administration should be obtained.

The application for a clinical trial conducted by an institution not yet certified for drug clinical trials may be submitted along with the application for drug registration.

Article 21 The investigator responsible for a drug clinical trial shall, in accordance with the relevant provisions, timely report adverse events occurred in the process of the clinical trial to the State Food and Drug Administration. If no adverse event occurs, the investigator shall collect relevant information and report to the State Food and Drug Administration monthly.

Article 22 The State Food and Drug Administration shall, in accordance with law, supervise and inspect the clinical trials of drugs for public health emergencies.


Chapter 6 Review, Approval and Monitoring of Drug Production

Article 23 The applicant shall, after completion of the drug clinical trials, submit the relevant data to the State Food and Drug Administration in accordance with the Provisions for Drug Registration.

Article 24 The State Food and Drug Administration shall, within 24 hours after receiving data submitted by the applicant, organize technical review, and at the same time notify the (food and) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government where the applicant is located to conduct the on-site inspection on the drug manufacturing conditions, and organize the sampling and testing of pilot products.

The (food and) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government shall, within five days, submit the result and opinion of the on-site inspection to the State Food and Drug Administration.

Article 25 Any newly-established drug manufacturer or manufacturer with newly-built manufacturing workshops or newly-added dosage forms for production may apply to the State Food and Drug Administration for a certificate of the Good Manufacturing Practice along with the application for drug registration. The State Food and Drug Administration shall, when conducting the drug registration review, immediately carry out an inspection on the Good Manufacturing Practice certification.

Article 26 The drug testing institution shall, after receiving the samples of three batches taken by the (food and) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government, immediately arrange the testing.

Upon completion of testing, the drug testing institution shall, within two days, complete the test report and submit it to the State Food and Drug Administration.

Article 27 The State Food and Drug Administration shall carry out technical review in accordance with Chapter 4 of the Procedure, and shall, within three days after the completion of the technical review, complete the administrative examination, make a decision and inform the applicant.
Where the State Food and Drug Administration decides to approve the drug, it shall issue the Letter of Approval for Drug Registration, and may grant an approval number for the drug at the same time if the applicant has appropriate manufacturing conditions; if it decides to disapprove the manufacturing, it shall issue a Disapproval Notice with reasons.

Article 28 Where a drug manufacturer or distributor, or a medical and health institution finds any new or serious adverse drug reaction or cluster adverse reaction relating to a specially approved drug for public health emergencies, it shall immediately report the case to the local (food and) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government, the health administrative department at the provincial level and the professional institution for adverse drug reactions monitoring.

The professional institution for adverse drug reactions monitoring shall regard drugs specially approved for public health emergencies as critically monitored products, analyze the collected case reports in accordance with the relevant provisions and timely report to the (food and) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government and the State Food and Drug Administration.

The State Food and Drug Administration shall reinforce the reevaluation of approved drugs for public health emergencies after they are marketed.


Chapter 7 Supplementary Provisions

Article 29 The measures for special review and approval of the medical devices for public health emergencies shall be separately formulated by the State Food and Drug Administration with reference to the relevant provisions of the Procedure.

Article 30 The Procedure shall go into effect as of the date of promulgation.





交通部


交通部关于我国加入《关于在领海和港口内使用卫星船舶地球站的国际协议》的通知
交通部


经国务院批准，我国于1993年11月3日向国际海事卫星组织总干事交存了加入《关于在领海和港口内使用卫星船舶地球站的国际协议》（以下称《协议》）的文件。国际海事卫星组织总干事已函告该组织所有成员国、签字者和其它国家，该《协议》于1993年11月3日对我
国生效。请遵照执行。

附件一：关于在领海和港口内使用国际海事卫星船舶地球站的国际协议
本协议各缔约国（下称“各缔约国”），为达到1975～1976年建立国际海事卫星系统国际会议的第3号建设中所设想的目标，并已决定改进海上遇险和人命安全通信以及船舶的效率和管理。
协议如下：
第一条
（1）根据本协议的规定和国际法所确立的航行权，各缔约国，在其领海和港口内，应许可经批准而适合国际海事卫星组织（ＩＮ－ＭＡＲＳＡＴ）所提供的海上空间段通信系统并正确安装在悬挂其它缔约国国旗的船上的船舶地球站（下称“国际海事卫星船舶地球站”）进行操作。
（2）此种许可，任何时候仅限于国际海事卫星船舶地球站使用卫星海上移动频率，并且国际海事卫星船舶地球站要符合国际电信联盟的适用的无线电规则以及本协议第2条所规定的条件。
第二条
（1）国际海事卫星船舶地球站的操作必须符合下列条件：
（ａ）其操作不得有损于沿海国的和平、良好秩序和安全；
（ｂ）其操作不得对沿海国领土边界以内的其它无线电业务操作产生有害干扰；
（ｃ）根据有关的国际公约，特别是根据国际电信联盟的无线电规则，对于遇险和安全通信必须给予优先权；
（ｄ）按有关的安全规定，在存有爆炸性气体的区域内，特别是在装卸油类和其它易燃物质的过程中，使用国际海事卫星船舶地球站，必须采取安全措施；
（ｅ）在不影响国际法所确立的航行权的情况下，国际海事卫星船舶地球站在沿海国主管部门的要求下应接受检查。
（2）在本协议中，“沿海国”系指根据本协议的规定，国际海事卫星船舶地球站在其领海和港口内操作的国家。
第三条
各缔约国，在不影响国际法所确立的航行权的情况下，可以限制、中止或禁止在其规定的港口和领海区域内使用国际海事卫星船舶地球站。在不影响缔约国所确定的这种限制、中止或禁止的生效的情况下，应尽速将这种决定通知本协议的保存者。
第四条
在不影响遇险和安全通信的情况下，本协议第一条（1）款中所述的许可，可限于船旗国按第一条（1）款的规定所给予有关沿海国船舶在其领海和港口内的权利。
第五条
本协议的任何条款不得被解释为阻止某一缔约国给予国际海事卫星船舶地球站的操作以更大的便利。
第六条
本协议不适用于军舰和其它用于非商业目的的政府船舶。
第七条
（1）任何国家可以通过下列方式成为本协议的缔约国：
（ａ）签署；或
（ｂ）需经批准、接受或核准的签署，然后再批准、接受或核准；或
（ｃ）加入或参加。
（2）本协议自一九八六年一月一日起到其生效时为止，在伦敦开放供签署，此后仍开放供加入或参加。
第八条
（1）本协议在二十五个国家成为缔约国之日后第三十天起生效。
（2）对于在本协议生效后交存批准书、接受书、核准书、加入书或参加文件的国家，本协议应在交存文件之日起对其生效。
第九条
缔约国可随时通知保存者退出本协议。该项退出应在保存者收到缔约国的书面退出通知书之日后第九十天起生效。
第十条
（1）国际海事卫星组织总干事为本协议的保存者。
（2）保存者应将下列情况迅速通知本协议的所有缔约国：
（ａ）本协议的任何签署；
（ｂ）本协议生效日期；
（ｃ）任何批准书、接受书、核准书、加入书或参加文件的交存；
（ｄ）某一国家停止作为本协议缔约国的日期；
（ｅ）任何有关本协议的其它通知和联系。
（3）本协议一经生效，保存者应按《联合国宪章》第102条将一份核证无误的副本送交联合国秘书长以供登记和公布。同时，保存者须分别将本协议一份核证无误的副本送交国际电信联盟和国际海事组织。
第十一条
本协议正本一份，用英文、法文、俄文和西班牙文写成。所有文本具有同等效力，由保存者保存。保存者须将核证无误的副本分送所有缔约国。
下列具名者均经各自政府正式授权，特签署本协议，以昭信守。

附件二：签署或加入《协议》国家名单 （截止至1993年11月3日）

国 家 签署或交存文件日期
阿根廷（签署）＊1 1992年9月9日
澳大利亚（签署） 1987年4月2日
奥地利（签署） 1990年6月11日
比利时（批准） 1990年1月22日
巴西（签署）＊1 1987年1月29日
加拿大（签署） 1988年3月15日
智利（签署） 1990年10月18日
中国（加入） 1993年11月3日
古巴（加入） 1993年9月15日
丹麦（签署） 1987年4月2日
芬兰（批准） 1990年6月18日
法国（签署）＊4 1990年7月27日
德国（批准） 1988年10月26日
希腊（批准） 1992年5月28日
印度（批准） 1991年6月21日
印度尼西亚（签署） 1993年8月13日
以色列（签署）＊1 1989年3月13日
意大利（签署） 1987年4月2日
科威特（批准）＊2 1989年5月11日
摩洛哥（签署）＊1 1992年5月7日
荷兰（接受）＊3 1987年6月24日
挪威（签署） 1986年10月3日
波兰（批准） 1988年2月29日
卡塔尔（签署） 1993年5月5日
罗马尼亚（批准） 1992年10月8日
俄罗斯联邦（签署）＊5 1986年10月9日
新加坡（签署） 1990年10月3日
南非（签署） 1989年4月18日
西班牙（批准） 1989年5月3日
瑞典（签署） 1988年7月20日
英国（批准） 1991年9月20日

注：＊1 有待批准
＊2 附有下列声明：
“科威特国批准《关于在领海和港口内使用卫星船舶地球站的国际协议》在任何意义上均不意味科威特国政府对以色列的承认，也不应导致科威特国和以色列国之间任何条约关系。”
＊3 荷兰王国的接受只适用于欧洲
＊4 附有下列声明
“在无保留签署由国际海事卫星组织缔约国第四届大会于1985年10月16日在伦敦通过的《关于在领海和港口内使用卫星船舶地球站的国际协议》时，法兰西共和国政府将严格遵守该协议第3和第4条，但每当形势需要时，将限制在其港口和领水内使用国际海事卫
星系统。”
＊5 由前苏联签署



1994年8月8日