Cost & Time for Drug China NMPA Register(Import Drug Licence (IDL) approval Phase)

◄ Cost & Time for Drug China NMPA Register(Import Drug Licence (IDL) approval Phase) ►

Tags: | NMPA | Pharmaceuticals | Drug | 药监局 | 医药品 | 药品 |

Phase C. Import Drug Licence (IDL) approval Phase

Step	ITEM	COST(USD)	TIME	Work content
3	FDA Application Dossiers Draft, Edit, Compile , Pre-review and Official Submitit	contact us	1-3 months	1. Compile clinical trial report and relevant clinical study dossiers according to the results of clinical trial 2. Modify quality standards of product and other application dossiers to be modified according to the results of NICPBP examination. 3. Compile 32 application dossiers required for CFDA IDL. 4. Formal submission to CFDA
4	CDE Technical Evaluation & Follow up	contact us	6- 10 Months ( Time is controlled by CDE ),	1．Follow up drug technical evaluation in CDE, communicate with reviewing technological expert, and solve problems met during review at any time. 2．Promptly submit supplemental dossiers required by CDE if technical dossiers need to be corrected.
5	Import Drug Licence CFDA Approval & Follow up	contact us	1-2 Months (Time controlled by CFDA )	Communicate with relevant officers, promote rapid and successful pass of Import Drug Licence CFDA Approval.
	Total:	contact us	10-14 months

Notes:

1． Abbreviations define: CFDA: China Food & Drug Administration ; CDE: Center for Drug Evaluation , NICPBP :National Institute for the Control of Pharmaceutical & Biological Products

2．The time of CFDA review , NICPBP products testing, CDE technical Evaluation etc, can not be controlled by the agent, so,any time be postponed cause by such step, will not be included in the time commitment appraisal of the agent service.

提示 Notice

不同类型的GACC注册，海外申请人可以根据自身情况，选择不同的渠道进行注册申请。
1. 如果你精通GACC注册流程，可以直接向中国海关提交免费申请，其网站为：www.customs.gov.cn or www.singlewindow.cn；
2. 如果你是第一次申请，不清楚GACC注册的程序h流程，申请文件要求等，可以通过CRA中国代理机构渠道申请注册，CRA会提供专业的注册咨询服务，帮助你顺利通过GACC注册审查，尽快获得GACC注册号。

Different types of GACC registration, overseas applicants can choose different channels to apply for :
1. If you specialise in the GACC registration process, you can submit a free application directly to China Customs, website: www.customs.gov.cn or www.singlewindow.cn;
2. If you are not clear about the registration process of GACC registration, application document requirements, etc., you can apply for registration through the channel of CRA (Chinese Representative Agency) , CRA will provide professional registration services to help you successfully pass the GACC registration review and get the GACC registration number quickly.

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◄ Cost & Time for Drug China NMPA Register(Import Drug Licence (IDL) approval Phase) ►

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