Abstract��OBJECTIVE To realize that our product regulatory dossier can be submitted at home and abroad simultaneously, to promote internationalization of generic drugs in our country, and to give some suggestions to improve the CTD regulatory dossier for our generic drugs. METHODS Researching on the international generic drugs requirements and implementation progress of CTD regulatory dossier, contrasting them in our country, and summarizing the thinking. RESULTS There are some differences of requirements between our CTD format filing and ICH CTD,and the implement progress of eCTD submissionis slow in our country. CONCLUSION According to the ICH CTD format, to promote the implementation of our CTD regulatory dossier for generic drugs smoothly and effectively, completing the CTD module format is suggested in our country and the eCTD submitting format is advised.
����,����. dz̸�ҹ�����ҩ��ͨ�ü����ļ���ʽע���ļ�[J]. �й�ҩѧ��־, 2016, 51(4): 329-334.
XIA Li, ZENG Su. A Review of the Common Technical Document (CTD) Regulatory Dossier for Generic Drugs in China. Chinese Pharmaceutical Journal, 2016, 51(4): 329-334.
China Food and drug administration. Opinions on deepening drug evaluation and approval reform and further encouraging drug innovation [EB/OL]. [2013-02-22]. http://www.sda.gov.cn/WS01/CL0844/78576.html.
[2]
China Food and drug administration. Requirements on application dossiers in CTD format for pharmaceutical products [EB/OL]. [2010-09-25]. http://www.sda.gov.cn/WS01/CL0844/54391.html.
[3]
Center for drug evaluation, CFDA. Starting the investigating for CTD submission dossier [EB/OL]. [2011-07-07]. http://www.cde.org.cn/news.do?method=largeInfo&id=312324.
[4]
Center for drug evaluation, CFDA. Starting the investigating for CTD submission dossier [EB/OL]. [2010-10-11]. http://www.cde.org.cn/news.do?method=largeInfo&id=311852.
[5]
ICH. M4: The Common Technical Document [EB/OL] . [2004-01-13] http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4_R3_Organisation/M4_R3__organisation.pdf.
[6]
ZHANG N, PING Q N. Introduction to the concept challenge of generic drugs research and development and evaluation in China[J]. Chin Pharm J(�й�ҩѧ��־),2010, 45(11): 872-875.
[7]
Center for drug evaluation, CFDA. Some notes about the technical evaluation for conductingthe CTD format [EB/OL] . [2011-04-12]. http://www.cde.org.cn/news.do?method=largeInfo&id=312136.
[8]
ZHANG B Z. Accelerate the pace of international standards and promote the application of CTD file format [J]. Chin Food Drug Administration(�й�ʳƷҩƷ���),2011,11: 50-52.
[9]
DEBBIE J. An overview of the common technical document (CTD) regulatory dossier[J]. Med Writing, 2014, 23(2):101-105.
[10]
ICH M4Q Guideline: Quality Overall Summary ofModule 2 and Module 3: Quality (R1) [EB/OL]. [2002-09-12]. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4_R1_Quality/M4Q__R1_.pdf.
[11]
ICH M4S Guideline: Nonclinical Overview andNonclinical Summaries of Module 2 and Module4: Safety (R2) [EB/OL]. [2002-12-20]. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4__R2__Safety/M4S_R2_.pdf.
[12]
Guidance for Industry ANDA Submissions �� Content and Format of Abbreviated New Drug Applications [EB/OL]. [2014-06-11] http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM400630.pdf.
[13]
EMA Generic / hybrid applications: questions and answers [EB/OL]. [2015-03-09]. http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2015/03/WC500183994.pdf.
[14]
ICH M4E Guideline: Clinical Overview and ClinicalSummary of Module 2 and Module 5: Clinical StudyReports (R1) [EB/OL]. [2002-09-12].http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4__R1__Efficacy/M4E__R1_.pdf.
[15]
ANTHONY C. The electronic common technical document[J]. Pharmac Med, 2006,20(3): 149-158.
[16]
Center for drug evaluation, CFDA [EB/OL].[2012-12-20]. http://www.cde.org.cn/dzkw.do?method=largePage&id=312897.
[17]
Center for drug evaluation, CFDA [EB/OL]. [2010-09-27]. http://www.cde.org.cn/news.do?method=largeInfo&id=312811.
[18]
Center for drug evaluation, CFDA [EB/OL].[2012-12-12]. http://www.cde.org.cn/dzkw.do?method=largePage&id=312889.
[19]
JU M. HUAHAI Pharmaceutical: Leader of the national pharmaceutical pioneer overseas [J]. Chin Food Drug Administration(�й�ʳƷҩƷ���), 2014(12): 63-67.
[20]
Tacrolimus Capsules of Hisun pharmaceutical in the EU market[J]. China Hospital CEO(�й�ҽԺԺ��), 2010,2010(18): 84.
[21]
CHEN Q Y, ZHU Y H, ZHAO L B, et al. Application and practice for e-submission of drug registration in EU[J]. Drug Evalu Res(ҩ�������о�),2014, 37(5): 401-403.
[22]
China Food and drug administration. Provisions for Drug Immediate Packaging Materials and Containers [EB/OL]. [2004-07-20]. http://www.cfda.gov.cn/WS01/CL0053/24499.html.
[23]
LI M Z, SUN H M, XIE L G,et al. Supervision and quality control on pharmaceutical packaging materials in China [J]. Chin Pharm Aff(�й�ҩ��), 2012, 26(2): 107-111.
[24]
Guidance for Industry: Container Closure Systems for PackagingHuman Drugs and Biologics [EB/OL]. [1999-05]. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070551.pdf.
[25]
GUIDELINE ON PLASTIC IMMEDIATE PACKAGING MATERIALS [EB/OL]. [2005-12-01]. http://www.gmp-compliance.org/guidemgr/files/PLASTIC-PACKAGING-MATERIALS-435903EN.PDF.
[26]
FDA. Guidance for Industry Sterile Drug Products Produced by Aseptic Processing��Current Good Manufacturing Practice [EB/OL]. [2004-09]. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070342.pdf.
[27]
ICH, M8 : Electronic Common Technical Document [EB/OL]. [2010-11-08]. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Multidisciplinary/M8/M8_eCTD_Concept_Paper.pdf.
[28]
ANDREAS S, HERWIG O. The electronic common technical document (eCTD). [J]. Drug Inf J, 2012,46(1): 124-139.
[29]
FDA. Providing Regulatory Submissions in Electronic Format �� Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications[EB/OL]. [2015-05-05]. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM333969.pdf.
[30]
PU G Y. The spirit of the national drug registration administration work conference 2015 [EB/OL]. [2015-04-08]. http://www.ouryao.com/article-6213-1.html.
2016, Vol. 51 
