進(jìn)口藥品流程及注冊(cè)程序

1、 * * * * * * * * * * * * * * * * * * * * * * * * * * * * * As to Drug Products (viz. Preparations, Formulations and Dosage Products A Summary 1 Drug Names. 2 Certifications. For example: CPP、GMP、Letter of authorization 、Patent non-infringement statement 3 Basis, Objectives and Reasons Referring to t

2、he Application and R & D. 4 Summary of Main Studies. 5 Draft of Packaging Insert; (SPC 6 Sample of Packaging and Labeling Draft. B Pharmaceutical Study Information 7 Summary of Pharmaceutical Research, 8 Experiment Data and Information and Relevant Literatures on the Research of Formula Constitution

3、 and Manufacturing Process for the Preparations. 10 Experiment Data and Information on the Research of Drug Quality Specification and analysis procedure and Related Literatures. 11 Draft of Quality Specifications and Testing Method and, Relevant Reasons Why Those Decisions being Made. 12 Certificate

4、 of Analysis (COA of Sample Product. 13 The Sources, VOA and Quality Specifications and Testing Method of Drug substance and Excipients. 14 Experiment Data and Information on the Research of Drug Stability and Related Literatures. 15 Reasons for the Selection of the Kind of Direct Packaging Material

5、/ Container, and the Quality Specification & Testing Method for those Material/Container. * C Pharmacology and Toxicology Study Information (the literature is acceptable if its available and appropriate, so you could provide appropriate literature to substitute for study alternatively * 16 Summary o

6、f Pharmacology and Toxicology Study. * 17 Primary Pharmacodynamics Study and Literatures. * 18 General Pharmacology Study and Literatures. * 19 Acute/Single Dose Toxicity Study and Literatures. * 20 Chronic Toxicity Study and Literature. * 21 Special Safety Study and Literatures of Hypersensitive (t

7、opical, systemic and photo-toxicity, Hemolytic and Topical * Irritative (to blood vessel, skin, mucous membrane, and * muscle Reaction. * 22 Study and Relevant Literatures on Pharmacodynamics, * Toxicity and Pharmacokinetics Changes Caused by the Interactions amongst Multiple Components in the Compo

8、und Product. * 23 Study and Literatures on Mutagenicity Test. * 24 Study and Literatures on Reproductive Toxicity. * 25 Study and Literatures on Carcinogenicity Test. * 26 Study and Literatures on Drug Dependenc, e. * 27 Study and Literature on Pre-clinical Pharmacokinetics. * D Clinical Study Infor

9、mation * (If you want a waiver of clinical trials in China, youd better provide the following information/data on clinical study conducted in the manufacturing country as detailed as you can, if the reviewers think the information/data and literature you provided are appropriate, the clinical trials

10、 may be exempted * 28Summary of Domestic and International Clinical Study. * 29 Investigational Plan and Clinical Study Protocol. * 30 Investigators Brochure. * 31 Sample of Informed Consent Form, Approval of the Ethics * Committee. * 32 Clinical Study Report 符合28號(hào)令規(guī)定的進(jìn)口藥品(3類新藥注冊(cè)流程圖 申請(qǐng)人提出進(jìn)口制劑注冊(cè)申請(qǐng)（報(bào)臨

11、床） 根據(jù)需要，對(duì)研制和生 產(chǎn)情況進(jìn)行現(xiàn)場(chǎng)檢查 SFDA形式審查，并通知中檢所進(jìn)行藥品檢驗(yàn)和標(biāo)準(zhǔn)復(fù)核（30日） CDE技術(shù)審評(píng)（90日） 中檢所組織藥品注冊(cè)檢驗(yàn)和標(biāo)準(zhǔn)復(fù)核（85日） （實(shí)際，方法樣品標(biāo)準(zhǔn)品問(wèn)題，往往85日） 要求申請(qǐng)人在4個(gè)月內(nèi)一次性補(bǔ)充資料 CDE對(duì)補(bǔ)充資料進(jìn)行審評(píng)（30日） SFDA審批流程（40日） SFDA不批準(zhǔn)或退審 SFDA批準(zhǔn)臨床試驗(yàn) 申請(qǐng)人將臨床試驗(yàn)方案和參加單位報(bào)SFDA臨床備案 實(shí)施臨床試驗(yàn) 注：由于檢驗(yàn)復(fù)核和發(fā)補(bǔ)問(wèn)題，注冊(cè)流程一般需要約12個(gè)月時(shí)間。 符合28號(hào)令規(guī)定的進(jìn)口藥品注冊(cè)流程圖 申請(qǐng)人完成臨床試驗(yàn)后，提出進(jìn)口制劑注冊(cè)申請(qǐng)（IDL申請(qǐng)） SFDA形式審查，并根據(jù)需要，組織臨床試驗(yàn)現(xiàn)場(chǎng)核查（30日） CDE技術(shù)審評(píng)（150日） 要求申請(qǐng)人在4個(gè)月內(nèi)一次性補(bǔ)充資料 CDE對(duì)補(bǔ)充資料進(jìn)行審評(píng)（50日） SFDA審批流程（40日） SFDA不批準(zhǔn)或退審 SFDA批準(zhǔn)進(jìn)口，獲得IDL或醫(yī)藥產(chǎn)品注冊(cè)證 注：如不發(fā)補(bǔ)，注冊(cè)流程一般需要約12個(gè)月時(shí)間。 四、藥品注冊(cè)代理機(jī)構(gòu)的服務(wù)內(nèi)容 * 提供前期技術(shù)和法規(guī)支持，保證國(guó)外制藥商正確準(zhǔn)備申報(bào)資料 所需