Approval for clinical trials of imported (incl. from Hong Kong, Macao and Taiwan) chemicals
2012年11月05日发布
一、项目名称：进口药品注册
I. Project name: Imported Drug Registration
二、许可内容：进口（含港、澳、台）化学药品临床试验批准，其分类按《药品注册管理办法》附件二注册分类，即：
II. Content of licensing: Approval for clinical trials of imported (including Hong Kong, Macao and Taiwan) chemicals, which are classified in accordance with Annex II of the “Provisions for Drug Registration”, namely:
注册分类1、未在国内外上市销售的药品。
RegistrationCategory 1, drugs not marketedathomeandabroad.
注册分类3、已在国外上市销售但尚未在国内上市销售的药品。
RegistrationCategory 3, drugsthathavebeenmarketedoverseasbutnotyetinthedomesticmarket.
三、实施依据：《中华人民共和国药品管理法》、《中华人民共和国药品管理法实施条例》、《药品注册管理办法》
III. Legal basis: "Drug Administration Law," "Regulations for Implementation of the Drug Administration Law,” and “ProvisionsforDrugRegistration”
四、收费：
IV. Charges:
进口药审评及审批收费45300元
Reviewandapprovalfeeforimported drugs: RMB45,300yuan
收费依据：《国家计委、财政部关于调整药品审批、检验收费标准的通知》〔计价格（1995）340号〕
Chargingbasis: "Notice of the State Planning Commission and the Ministry of Finance on the Adjustment of Fees for Drug Review, Approval and Tests" [J.J.G. (1995) No.340]
五、数量：本许可事项无数量
V. Quantity restrictions: No quantity limit forthislicensing
六、申请人提交材料目录：
VI. List of application dossiers:
《进口药品注册申请表》
"Application Form for the Registration of Imported Drugs”
（一）综述资料
(I) Summary data
1.药品名称。
a) Name of drug;
2.证明性文件。
b) Approval documents;
3.立题目的与依据。
c) Objective and rationale for the study;
4.对主要研究结果的总结及评价。
d) Summary and evaluation of study results;
5.药品说明书、起草说明及相关参考文献。
e) A draft of insert sheet, notes to the draft and the latest literatures;
6.包装、标签设计样稿。
f) Draft of the designed package and label.
（二）药学研究资料
(II) Pharmaceutical research data
7.药学研究资料综述。
g) Overview of pharmaceutical research data.
8.原料药生产工艺的研究资料及文献资料；制剂处方及工艺的研究资料及文献资料。
h) API production process research data and literature; drug formulations and processes research data and literature.
9.确证化学结构或者组份的试验资料及文献资料。
i) Testing data and literature for confirmation of chemical structure or components.
10.质量研究工作的试验资料及文献资料。
j) Testing data and literature data for quality research.
11.药品标准及起草说明，并提供标准品或者对照品。
k) Drug standards and the drafting instructions, and standard substance or reference substance.
12.样品的检验报告书。
l) Sample inspection report.
13.原料药、辅料的来源及质量标准、检验报告书。
m) Sources of pharmaceutical APIs and excipients, quality standards, and inspection reports.
14.药物稳定性研究的试验资料及文献资料。
n) Testing data and literature for drug stability studies.
15.直接接触药品的包装材料和容器的选择依据及质量标准。
o) Rationale for selection and specifications of immediate packaging material and container.
（三）药理毒理研究资料
(III) Pharmacology and toxicology research data
16.药理毒理研究资料综述。
p) Review of pharmacology and toxicology research data.
17.主要药效学试验资料及文献资料。
q) Main pharmacodynamic testing data and literature.
18.一般药理学的试验资料及文献资料。
r) General pharmacology testing data and literature.
19.急性毒性试验资料及文献资料。
s) Acute toxicity testing data and literature.
20.长期毒性试验资料及文献资料。
t) Long-term toxicity testing data and literature.
21.过敏性（局部、全身和光敏毒性）、溶血性和局部（血管、皮肤、粘膜、肌肉等）刺激性等特殊安全性试验资料和文献资料。
u) Allergic (topical, systemic and light sensitive toxicity), hemolytic and local (blood vessels, skin, mucous membranes, muscle, etc.) irritation and other special safety related testing data and literature.
22.复方制剂中多种成份药效、毒性、药代动力学相互影响的试验资料及文献资料。
v) Testing data and literature for interactions of the efficacy, toxicity and pharmacokinetics of multiple ingredients in compound preparation.
23.致突变试验资料及文献资料。
w) Carcinogenicity testing data and literature.
24.生殖毒性试验资料及文献资料。
x) Reproductive toxicity testing data and literature.
25.致癌试验资料及文献资料。
y) Carcinogenicity testing data and literature.
26.依赖性试验资料及文献资料。
z) Dependence testing data and literature.
27.非临床药代动力学试验资料及文献资料。
aa) Non-clinical pharmacokinetic studies and literature.
（四）临床试验资料
(IV) Clinical trials data
28.国内外相关的临床试验资料综述。
bb) Summary of related clinical trial data at home and abroad.
29.临床试验计划及研究方案。
cc) Clinical trial protocols and study protocol.
30.临床研究者手册。
dd) Clinical investigator's brochures.
31.知情同意书样稿、伦理委员会批准件。
ee) A draft of Informed Consent, Ethics Committee’s approval letters.
32.临床试验报告。
ff) Clinical trial reports.
以上申报材料具体要求详见《药品注册管理办法》附件二。
Specific requirements for the above application dossiers are detailed in Annex II of the “Provisions for Drug Registration”.
七、对申请资料的要求：
VII. Requirements for application dossiers:
（一）申报资料的一般要求：
(I) General requirements for application dossiers:
1、申报资料首页为申报资料项目目录，目录中申请资料项目按《药品注册管理办法》(国家食品药品监督管理局令第28号)附件二的顺序排列。
1. The first page of the dossiers shall be a directory for application items, which shall be arranged in order as per Annex I of the “Provisions for Drug Registration” (SFDA Order No. 28).
每项资料封面上注明：药品名称、资料项目编号、项目名称、申请机构联系人姓名、电话、地址。
Each dossier shall indicate on its cover: the name of the drug and application item, document item number, and the name, phone number and address of contact person and the applicant.
2、申报资料应使用A4规格纸打印或复印，内容完整、规范、清楚，不得涂改，数据真实、可靠。
2. All documents in the dossier shall be printed or copied in A4 size paper. The content shall be complete, standardized, clear, without alteration, and the data must be real and reliable.
3、资料按套装入档案袋，档案袋封面注明：申请分类、注册分类、药品名称、本袋所属第X套第X袋每套共X袋、原件/复印件联系人、联系电话、申请注册代理机构名称。
3. The documents shall be put in portfolio envelope(s), on which the application classification, registration category, drug name, the envelope number of set X, the total number of envelopes in the set, original or copy, the contact person, phone number and the name of registration application agent shall be indicated.
4、注册申请报送2套完整申请资料（至少1套为原件）和1套综述资料复印件，申请表4份（1份原件，3份复印件）分别装入各套资料中（全套原件资料内放入1份申请表原件，1份申请表复印件）。
4. Two sets of complete application dossiers (at least one set is in the original) and one set of review documents in hard copy shall be submitted for registration application. Four application forms (1 in the original and 3 in hard copy) shall be separately put into each set of dossier (the original application form and a hard copy shall be put in the set of the dossier in the original).
5、《进口药品注册申请表》：从国家食品药品监督管理总局网站（www.cfda.gov.cn）下载药品注册申请表报盘程序，按要求填写后打印并保存，要有境外申请人的签字及国内代理机构盖章签字。
5. "Import Drug Registration Application Form": the drug registration application form submission program could be downloaded from CFDA website (www.cfda.gov.cn); the application form shall be filled in as required, printed and saved, and shall be signed by the overseas applicant, and signed & sealed by its domestic agent.
6、在邮寄或者递交申请资料时应将申请表的电子版发送到以下药品注册专用电子邮箱地址：slzx@cfda.gov.cn。
6. When mailing or submitting the application dossiers, the electronic version of the application form shall be sent to the following e-mail address dedicated for drug registration: slzx@cfda.gov.cn.
7、电子申请表与纸质申请表的数据核对码应一致。
7. The data checking code on the electronic and paper application form should be identical.
8、外文资料应翻译成中文。
8. Foreign language materials shall be translated into Chinese.
（二）申报资料的具体要求：
(II) Specific requirements for application dossiers:
1、《进口药品注册申请表》的填写应准确、规范，符合填表说明的要求。
a) The "Application Form for the Registration of Imported Drug" should be filled in an accurate and standardized manner in line with the requirements of explanatory notes.
(1)药品注册分类：参照《药品注册管理办法》（国家食品药品监督管理局令第28号）附件二的相应条款填写。
(1) Drug Registration Category: Fill in as per the corresponding article of Annex II of the “Provisions for Drug Registration” (SFDA Order No. 28).
申报资料按照化学药品《申报资料项目》要求报送。
The application dossiers shall be submitted in accordance with the requirements for "Items of application dossiers" for chemicals.
申请未在国内外获准上市销售的药品，按照注册分类1的规定报送资料；其他品种按照注册分类3的规定报送资料。
As for the application for drugs not approved for marketing at home and abroad, dossiers in accordance with the requirements of Registration Category 1 shall be submitted while for the application for other products, provisions on Registration Category 3 shall be followed.
也可以报送ICH规定的CTD资料，但“综述资料”部分应按照化学药品《申报资料项目》要求报送。
ICH-required CTD information can also be submitted, but the "Summary data" section should be submitted in accordance with the requirements for "Items of application dossiers" for chemicals.
属于注册分类1的药物，应当至少是已在国外进入II期临床试验的药物。
Drugs in Registration Category I should at least have entered Phase II clinical trials in a foreign country.
(2) 附加申请事项：可同时提出减免临床、非处方药等附加申请。
(2) Additional application: other applications can be raised at the same time, such as exemption from clinical trials, non-prescription drugs, etc.
(3) 规格：申请注册的药品有多个规格的，一表一规格，各自发给受理号。
(3) Specifications: where the drug for registration has multiple specifications, an acceptance number shall be designated for each specification in a separate application form.
(4) 包装规格：多个包装规格填写在一份申请表内。
(4) Packaging specifications: multiple packaging specifications shall be filled in one application form.
合剂、口服溶液、颗粒剂、软膏剂、滴眼剂、贴剂等非注射制剂，在制剂处方不改变时，其装量、尺寸等不同时，按照不同的包装规格管理，填写同一份申请表。
Multiple package volumes and sizes of non-injectable formulations like agents, oral solutions, granules, ointments, eye drops, and pastes with the same drug formulations shall be subject to uniform management according to different packaging sizes, and filled in one application form.
(5) 申请人：申请表上机构1和机构2为境外持证商和生产厂信息，这两项不能空缺。
(5) The applicant: on the application form, organization 1 and organization 2 refer to information of overseas licensed providers and production plant, these two items cannot be left blank.
除港澳台地区的申请人，企业名称、地址等均应用英文填写；机构3为境外包装厂信息，应根据实际情况填写，除港澳台地区的申请人，企业名称、地址等均应用英文填写；境内代理机构项应务必用中文填写相关信息。
Except for the applicants in Hong Kong, Macao and Taiwan regions, the business name, address, etc. should be filled in English; Organization 3 refers to the information for overseas packaging plants, which should be completed in accordance with the actual situation. Except for the applicants in Hong Kong, Macao and Taiwan regions, the business name, address, etc. should be filled in English; the relevant information of domestic agencies should be filled in Chinese.
(6) 申请表上的信息与所提供的证明性文件应一致。
(6) The information on the application form should be consistent with the proof documents as provided.
2、如有同品种处于监测期，则本品不能申请进口注册。
b) While there is a same product in observation period, the product as filed shall not apply for import registration.
3、证明性文件的要求：
c) Requirements for proof documents:
(1)生产国家或者地区药品管理机构出具的允许药品上市销售及该药品生产企业符合药品生产质量管理规范的证明文件、公证文书及其中文译本。
i. Proof documents issued by relevant drug regulatory authority of the manufacturing country or region for marketing authorization and GMP-compliance, as well as their notarization documents, proof documents and Chinese translations thereof.
属于注册分类1的药物，证明文件可于完成在中国进行的临床试验后，与临床试验报告一并报送；但在申报临床试验时，必须提供药品生产国家或地区药品管理机构出具的该药物的生产企业符合药品生产质量管理规范的证明文件。
The proof documents for drugs in Registration Category I can be submitted together with the clinical trial reports after the trials are completed in China; however, when applying for clinical trials, the applicant must provide proof documents issued by drug regulatory authorities of the manufacturing country or region to approve GMP compliance of the manufacturers.
①申请人提供的国家或者地区药品管理机构出具的允许药品上市销售及该药品生产企业符合药品生产质量管理规范的证明文件，应当符合世界卫生组织推荐的统一格式。
The above proof documents shall comply with the WHO recommended uniform format.
其他格式的文件，必须经所在国公证机构公证及驻所在国中国使领馆认证。
FilesinotherformatsmustbenotarizedbypublicnotaryorganizationsofthecountryoforiginandcertifiedbyChineseembassiesandconsulatesinthecountry.
②在一地完成制剂生产由另一地完成包装的，应当提供制剂厂或包装厂所在国家或地区药品管理机构出具的允许药品上市销售及该药品生产企业符合药品生产质量管理规范的证明文件。
For preparations produced in one place and packaged in another, the applicant must provide proof documents issued by drug regulatory authorities of the manufacturing country or region to permit drug marketing and prove GMP compliance of the manufacturers.
③未在生产国家或者地区获准上市销售的，可以提供持证商总部所在国或者地区药品管理机构出具的允许药品上市销售及该药品生产企业符合药品生产质量管理规范的证明文件。
For drugs not yet approved for marketing in the manufacturing country or region, the applicant can provide proof documents issued by drug regulatory authorities of the country or region of the certificate holders' headquarters to permit drug marketing and prove GMP compliance of the manufacturers.
提供持证商总部所在国或者地区以外的其他国家或者地区药品管理机构出具的允许药品上市销售及该药品生产企业符合药品生产质量管理规范的证明文件的，经国家食品药品监督管理总局认可。
Proofdocumentsissuedbydrugregulatoryauthoritiesofcountriesorregionsotherthanthoseofthecertificateholders’ headquarterstopermitdrugmarketingandprovetheGMPcomplianceofmanufacturersmustbecertifiedbyCFDA.
④原料药可提供生产国家或者地区药品管理机构出具的允许该原料药上市销售及该药品生产企业符合药品生产质量管理规范的证明文件。
For APIs, the applicant can provide proof documents issued by drug regulatory authorities of the manufacturing country or region to permit the marketing of drugs and to prove the GMP compliance of the manufacturers.
也可提供欧洲药典适用性证明文件（CEP）与附件，或者该原料药主控系统文件（DMF）的文件号以及采用该原料药的制剂已在国外获准上市的证明文件及该药品生产企业符合药品生产质量管理规范的证明文件。
The applicant can also provide certificate of European Pharmacopoeia (CEP) and attachments, or API drug master files (DMF), as well as proof documents approving the marketing of preparations made with such APIs overseas and documents proving GMP compliance of the manufacturers
⑤申请国际多中心临床试验的，应提供其临床试验用药物在符合药品生产质量管理规范的条件下制备的情况说明。
As for the international multi-center clinical trials, introductions of the preparations of clinical trial drugs under conditions in compliance with GMP standards shall be provided for the application.
⑥对于生产国家或地区按食品管理的原料药或者制剂，应提供该国家或地区药品管理机构出具的该生产企业符合药品生产质量管理规范的证明文件，或有关机构出具的该生产企业符合ISO9000质量管理体系的证明文件，和该国家或者地区有关管理机构允许该品种上市销售的证明文件。
For APIs or formulations that are managed as foods in the manufacturing country or region, the applicant shall provide the proof documents issued by the drug regulatory authorities of the manufacturing country or region to prove GMP compliance of the manufacturers, or proof documents issued by related institutions to prove compliance with ISO9000 Quality Management system, and certificates issued by relevant regulatory agencies in the country or region to authorize the marketing of drugs.
⑦应提供原件，如是复印件应同时出具所在国公证机关出具的公证书原件及驻所在国中国大使馆的认证书原件。
The originals shall be provided. While hard copies are submitted, the original copy of notarization document(s) issued by the public notary office of the country of origin, and the original copy of the certificate(s) issued by the Chinese Embassy in the country shall be filed at the same time..
⑧证明文件、公证书、认证书不得自行拆开。
Government proof documents, notarial documents and certificates shall not be unpacked without permission.
⑨文件上的出口国、进口国、药品名称、商品名(尤其是外文商品名)、规格、是否在出口国批准上市、是否已经在出口国上市销售、持证商、生产厂家等重要信息应与申请表上填写的相应信息一致。
The key information of the documents should be consistent with the corresponding information filled in the application form, such as the exporting country, importing country, drug name, product name (especially foreign trade name), specification, status of whether or not approved for marketing or already marketed in the exporting country, certificate holder, and manufacturers etc.
⑩所提供的证明文件均应在有效期内。
All proof documents as provided must be within the validity period.
(2)由境外制药厂商常驻中国代表机构办理注册事务的，应当提供《外国企业常驻中国代表机构登记证》复印件。
(2) Where a foreign manufacturer’s representative office in China deals with the registration issues, copies of Registration Certificate of Resident Office of Foreign Enterprise shall be provided.
境外制药厂商委托中国代理机构代理申报的，应当提供委托文书、公证文书及其中文译本，以及中国代理机构的《营业执照》复印件。
Where a foreign manufacturer authorizes a domestic enterprise or agency for the registration issues, copies of the authorization letters with notarized documents and the Chinese translation as well as the Business License of the domestic enterprise or agency shall be provided
(3)申请的药物或者使用的处方、工艺等专利情况及其权属状态说明，以及对他人的专利不构成侵权的声明。
(3) Introductions of the patent status and ownership situation of the drug for application or its prescriptions and production processes, as well as statements of non-infringement to other patents.
八、申办流程示意图：
VIII. Application process diagram:
九、许可程序：
IX. Licensing procedures:
（一）受理：
(I) Acceptance:
申请人向行政受理服务中心提出申请，按照本《须知》第六条所列目录提交申请材料，受理中心工作人员对申请材料进行形式审查。
After the application is filed to the Administrative Acceptance Service Center, and the application dossier submitted is in accordance with the list in VI of this Notice, the format examination shall be conducted by the work staff of the Center.
申请事项依法不需要取得行政许可的，应当即时告知申请人不受理；
Where the application item is not subject to administrative approval according to law, a decision of non-acceptance shall be notified to the applicant immediately.
申请事项依法不属于本行政机关职权范围的，应当即时作出不予受理的决定，并告知申请人向有关行政机关申请；
Where the application item is not within the functions of the administrative authority, a decision of non-acceptance shall be made immediately, and the applicant shall be informed to launch the application to relevant administrative authority.
申请材料存在可以当场更正的错误的，应当允许申请人当场更正；
Where in the application dossier, there are errors that can be corrected on the spot, the applicant shall be allowed to make the corrections on the spot.
申请材料不齐全或者不符合法定形式的，应当当场或者在五日内一次告知申请人需要补正的全部内容，逾期不告知的，自收到申请材料之日起即为受理；
Where the application dossier is incomplete or does not meet the statutory format, the applicant shall be informed of all the supplements and amendments to be made once and for all on the spot or within five days. If the applicant is not informed within the above-mentioned period, the application shall be deemed as accepted from date of receipt of application dossiers.
申请事项属于本行政机关职权范围，申请材料齐全、符合法定形式，或者申请人按照本行政机关的要求提交全部补正申请材料的，应当受理行政许可申请。
Where the application dossier is within the functions of the administrative authority, the application dossiers are complete and comply with the statutory format, or where the applicant has submitted all supplements and amendments in accordance with the requirements of the administrative authority, the application for administrative approval shall be accepted.
（二）药品注册检验：
(II) Drug registration inspection:
行政受理服务中心受理后，国家食品药品监督管理总局通知中检院组织进行注册检验、确定审批或审评相关事项等工作，应当在受理之日起30日内完成。
After the Administrative Acceptance Service Center accepting the application, CFDA shall inform NIFDC to conduct registration inspection, determine issues related to the approval or review, which shall be completed within 30 days from the date of acceptance.
中检院组织检验样品、复核标准85日，特殊药品和疫苗类制品115日，其时限与国家局审查、国家局药品审评中心技术审评并行，具体时限分配如下：
NIFDC has a time limit of 85 days to test samples and review the standards, and a time limit of 115 days for inspection of special drugs and vaccine products, the time frame for NIFDC inspection is in parallel with that for CFDA examination and CDE technical review, and the specific time frame is allocated as follows:
中检院收到资料和样品后，应当在5日内安排有关药品检验所进行注册检验。
After receiving information and samples, NIFDC shall arrange drug control institutions to conduct registration test within five days.
承担进口药品注册检验的药品检验所在收到资料、样品和有关标准物质后，应当在60日内完成注册检验并将药品注册检验报告报送中检院；特殊药品和疫苗类制品的样品检验和药品标准复核可以在90日内完成。
The competent drug control institutions shall complete the registration inspection within 60 days from the receipt of dossiers, samples and related standard substances and submit the report to NIFDC; the sample tests and re-review of drug standards for special drugs and vaccine products can be completed in 90 days.
中检院接到药品注册检验报告和已经复核的进口药品标准后，应当在20日内组织专家进行技术审查，必要时可以根据审查意见进行再复核。
After receiving the registration test reports and imported drug registration standards, which have been reviewed, the technical review shall be carried out by experts within 20 days; if necessary, re-review shall be conducted as per the review comments.
（三）技术审评：
(III) Technical review:
在药品注册检验的同时，行政受理服务中心将申请资料移送国家食品药品监督管理总局药品审评中心进行技术审评。
Alongwithdrugregistration, AdministrativeAcceptanceServiceCentershalltransfertheapplicationdossierstoCFDACenterforDrugEvaluationforoveralltechnicalreview.
国家食品药品监督管理总局药品审评中心按照有关的技术审评原则，在90日内完成技术审评（获准进入特殊审批程序的品种80日内完成）。
CDE of CFDA shall complete the technical review within 90 days in accordance with the technical review principles (80 days for products approved of special approval process).
技术审评完成后，对于不符合国家食品药品监督管理总局药品审评中心技术审评要求的，发给补充资料通知，申请人在4个月内补充资料，药品审评中心在不超过30日内完成补充资料的审查（进入特殊审批程序的品种20日内完成）。
After the completion of the technical review, the Notice for supplementary material should be issued to applicants failed to meet the technical review requirements of the CDE, who shall supplement the dossiers within four months, and CDE shall complete the review of the supplementary dossiers in no more than 30 days (20 days for products approved of special approval process).
（四）行政许可决定：
(IV) Decision of administrative examination & approval:
在收到药品审评中心完成技术审评的资料后，国家食品药品监督管理总局在20日内作出许可决定。
After receiving CDE’s completed technical review data, CFDA shall make licensing decisions within 20 days.
20日内不能作出决定的，经主管局领导批准，可以延长10日
If a decision cannot be made within 20 days, and extension of 10 days can be granted with competent leader’s consent.
（五）送达：
(V) Delivery:
自行政许可决定作出之日起10日内，CFDA行政受理服务中心将行政许可决定送达申请人。
Within 10 days from the date of decision making of administrative examination & approval, CFDA Administrative Acceptance Service Center shall deliver the decision to the applicants.
（六）复审：
(VI) Review:
申请人对国家食品药品监督管理总局作出的决定有异议的，在申请行政复议或者提起行政诉讼前，可以在收到决定之日起60日内填写《药品注册复审申请表》，向国家食品药品监督管理总局提出复审申请并说明复审理由。
For disagreements of CFDA decision, the applicant can, prior to administrative reconsideration or administrative litigation, explain the reasons and apply for re-review to CFDA within 60 days from the date of receipt of the decision.
复审的内容仅限于原申请事项及原申报资料。
Thecontentsofthere-reviewshallbelimitedtoonlytheoriginalapplicationitemsandtheoriginalapplicationdossiers.
国家食品药品监督管理总局接到复审申请后，应当在50日内作出复审决定，并通知申请人。
After receiving the application for re-review, CFDA shall make a decision within 50 days and notify the applicant.
维持原决定的，国家食品药品监督管理总局不再受理再次的复审申请。
Iftheoriginaldecisionismaintained, CFDAshallnolongeracceptrepeatedapplicationforre-review.
复审需要进行技术审查的，国家食品药品监督管理总局应当组织有关专业技术人员按照原申请时限进行。
Ifthere-reviewrequirestechnicalre-review, CFDAshouldorganizerelevantprofessionalandtechnicalpersonneltoperformthere-reviewwithintheoriginalapplicationtimelimits.
十、承诺时限：
X. Commitmentoftimeframe:
自受理之日起110日内作出行政许可决定（获准进入特殊审批程序的品种的品种：100日内作出）（注：国家食品药品监督管理总局在20日内作出许可决定。
The administrative licensing decision shall be made within 110 days from the date of acceptance (100 days for products allowed to enter into the special approval procedures) (Note: CFDA shall make the decision within 20 days.
20日内不能作出决定的，经主管局领导批准，可以延长10日）。
If a decision cannot be made within 20 days, and extension of 10 days can be granted with competent leader’s consent.)
以上时限不包括申请人补充资料及补充资料审评所需的时间。
Theabovetimeframesdonotencompassthetimerequiredfortheapplicantstosupplementinformationandthere-reviewofsupplementaryinformation.
十一、许可证件有效期与延续：
XI. Licensevalidityandrenewal:
药物临床试验被批准后应当在3年内实施。
Drugclinicaltrialsshouldbeimplementedinthreeyearsafterbeingapproved.
逾期未实施的，原批准证明文件自行废止；仍需进行临床试验的，应当重新申请。
Theoriginalapprovaldocumentsshallbeautomaticallyannulledforoverdueimplementation; undersuchcases, iftheclinicaltrialstillneedstobeconducted, itshouldbesubjecttore-application.
十二、许可年审或年检：无
XII. Annualinspectionorannualreviewofthelicense: None
十三、实施机关：
XIII. AuthorityofImplementation:
实施机关：国家食品药品监督管理总局
Implementedby: CFDA
受理地点：国家食品药品监督管理总局行政受理服务中心
Acceptedat: CFDAAdministrativeAcceptanceServiceCenter
十四、受理咨询与投诉机构：
XIV. Institutionsforinquiriesandcomplaints:
咨询：国家食品药品监督管理总局
ForInquiries: CFDA
投诉：国家食品药品监督管理总局驻局监察局、法制司
ForComplaints: CFDABureauofInvestigationandEnforcement, DepartmentofLegalAffairs
注：本须知工作期限以工作日计算，不含法定节假日
Note: The time frame of this GUIDANCE counts on working days, excluding legal holidays下载本文
