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.





１９９５年物证技术学和侦查学研究的回顾与展望
法学家 发表时间：199601
作者：徐立根/何家弘/施正文

一、1995年物证技术学研究的回顾与展望
（一）1995年的回顾
1995年物证技术学研究主要集中在以下几个方面：

1.物证技术学的理论体系和学科地位。物证技术学是一门新兴学科，其理论体系和学科地位既是本学科领域内研究的重点也是难点。有的学者对这一问题进行了较为系统和全面的论述，明确了物证技术学的理论体系应该包括的主要内容，并指出了物证技术学应属于法学专业下属的二级学科。有关学者还受国家有关部门的委托就作为法学专业下二级学科的物证技术学学科研究现状与发展趋势写出了调查报告。


2.物证技术鉴定的制度。随着我国法制建设的发展，完善物证鉴定制度的要求也日益强烈。在这一问题上，有的学者论述了如何保证鉴定权的正确行使和如何规范鉴定活动；有的学者探讨了建立统一的物证鉴定机构的可能性；还有的学者对外国的鉴定制度进行了比较研究，探讨了鉴定的委托、鉴定人的诉讼地位、鉴定人的资格和鉴定结论的评断等方面的制度问题，以求为中国物证鉴定制度的改革和完善提供借鉴。


3.物证摄影技术。这一领域的研究成果主要集中在不同介质上物证的拍摄技术和方法上，例如，在物证拍摄时消除金属表面反光点的方法；拍摄透明玻璃上单面遗留的汗液灰尘混合手印的方法；使用定向反射照相提取潜在手印的方法等。


4.痕迹技术。痕迹技术是物证技术学的一个重要科研领域。1995年在各类学术刊物上发表了上百篇关于手印、足迹、工具痕迹、枪弹痕迹的显现、提取、检验等技术的文章。其中，有的学者探讨了指纹特征概率的计算方法；有的学者研究了显现不同潜在手印的方法；有的学者就步法特征的价值和鞋底穿用特征做出了实验调查报告；有的学者探讨了工具痕迹检验的理论；有的学者研究了撬盗保险柜痕迹和开锁痕迹的检验方法；还有的学者探讨了弹壳发射痕迹的模糊识别原理等。


5.文书物证技术。随着社会中涉及文书物证之案件的迅速增多，有关文书物证技术的研究也有了极大的扩展。1995年国内学者专家在这一领域的研究主要包括：应用笔痕特征鉴定相对书写时间；采用多种技术手段鉴定伪造合同的绝对书写时间；签名字迹的检验方法；模仿笔迹的特点；少量残缺字迹的检验；被消退字迹的检验；复印文书的检验；原子印章印文的鉴定；区分复写字迹与圆珠笔字迹的方法；裂解色谱在文书物质材料检验中的应用等。

6.微量化学物证技术。随着仪器分析技术的迅速发展，
微量化学物证检验技术有了突破性发展，这主要表现在从定性对比分析发展到定量比较分析，从整体定量分析发展到成分扫描成象分析，从单项分别检验发展到多项综合分析等方面。国内学者在过去一年内除了对这一领域的总体性研究外，还在许多具体技术和方法上取得了众多的科研成果。例如：运用扫描电镜和能谱仪检验油漆物证的方法；美发用品对毛发残留清洁剂荧光特性的影响；鉴别毛发定型剂的荧光分析法；测定涤纶纤维上分散染料的方法；烟头的检验技术；有机磷农药的固相萃取分析技术；玻璃上指纹痕迹微量附着物的反射红外光谱分析法；头皮屑与尼龙屑的红外光谱检验等。

7.生物物证技术。生物物证技术是物证技术学的重要组成部分之一。在这个领域内，DNA检验技术仍然是一个研究的重点，
而且人们的研究开始从检验技术本身发展到检验结论在侦查和司法实验中的应用及其相关的问题，有的学者还探讨了植物 DNA 作为证据的可能性。
此外，1995年生物物证技术领域内的主要研究成果还包括：人类毛发同源鉴定中的元素分析和统计分析；暴力强奸案中毛发的中子活化分析；混合斑中精子血型的测定方法；微量血痕AB型粘附法检验等。

（二）今后的展望

1995年我国物证技术学领域的研究工作取得了丰硕的成果。我们认为，未来一年在这一领域的主要研究课题将包括：物证技术学的基础理论研究；我国物证鉴定体制的改革与完善；物证鉴定结论的采用标准；痕迹物证、文书物证、微体物证、生物物证技术领域内检验水平的提高和新技术新方法的开发与利用；外国物证技术学科研成果的借鉴。

二、1995年侦查学研究的回顾与展望
（一）1995年的回顾
1995年是我国侦查学研究相当活跃的一年。北京刑侦学会于4
月份召开了“学术论文交流会”。国际刑警组织大会和世界反贪污大会也于秋季分别在北京召开。围绕上述会议，国内专家学者就犯罪侦查中有关问题进行了广泛深入的研讨，并取得累累硕果。1995年我国侦查学研究的主要问题包括以下几个方面：

1.侦查学基本理论。
一些学者在回顾总结前一时期侦查学基本理论研究的基础上，对这一问题进行了新的探索，并提出了一些新的构想。有人认为，侦查学的概念应包括该学科的逻辑起点、基本内容和研究目的，因此应表述为“研究犯罪行为与侦查行为的矛盾、规律及侦查对象的科学。有人提出，侦查学的基础理论是多层次的，包括政治理论、技术理论、方法论、特定基础理论、相关学科基础理论等。有人认为，侦查学的学科体系应以犯罪行为与侦查行为的关系为轴线，以犯罪行为和侦查行为为逻辑起点，以多层次的基础理论、犯罪行为与侦查行为的关系和规律、侦查对策和方法为内容来构造等。

2.我国侦查体制改革。
一些学者认为传统的侦查体制滞后于形势的发展变化，因此应抓住机遇加速侦查体制的改革。有人认为应在侦查中引入竞争机制，全面推行“探长制”和“破案责任制”。有人对“大刑侦”体制的内涵提出了新的见解。有人提出应完善省、市、县和派出所的四级破案制度。有人认为应在侦查工作中确定精神鼓励与物质奖励相结合的激励机制。有人提出了实行“探长制”的具体措施。还有人提出了建立侦查员等级制度的设想等。


3.侦查思维。关于侦查思维的研究已经从一般性特征描述转入对具体思维形态和功能的分析，并且从不同角度对侦查思维的理论体系加以完善。有人论述了侦查中对抗思维的方法。有人论述了逆向思维在侦查中的应用。有人探讨了侦查思维的障碍及其排除方法。有人论述了侦查中辩证思维方法的特征和作用。有人具体分析了侦查中的比对推理、矛盾分析推理和侦查假设等逻辑思维的形式。有人还研究了培养侦查人员正确运用侦查思维和提高侦查思维能力的方法等。

4.侦查谋略。
关于侦查谋略的研究主要表现在一些具体谋略的运用上。例如，有人研究了孙子的“诡道”思想在侦查中的运用；有人研究了迷惑型侦查谋略在暴力犯罪侦查中的运用；还有人研究了谋略在贩毒案件侦查中的运用等。