Cost & Time for Drug China NMPA Registration (Clinical Trials Permission (CTP) Phase)

◄ Cost & Time for Drug China NMPA Registration (Clinical Trials Permission (CTP) Phase) ►

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

Imported Drug CFDA Registration Charge and timetable

Phase A. Clinical Trials Permission (CTP) Phase:

Step	ITEM	COST (USD)	TIME	Work content
1	China CFDA Registration consultant & Legal responsibility Agency	contact us	5 years	On behalf of the applicant, communicate with the CFDA and relevant government departments, in the 5 years certificate validity period
2	Original Legal &Technical documents prepare and Translation (English-Chinese,)	contact us	1-2 Months	1.Explanation the CFDA registration procedure and regulation for Applicant in detail 2. Provide the list of application dossiers need to be submitted, including technical & legal documents, and describe the requirements of each documents in detail. 3. Translate all Original Legal &Technical documents provided by Applicant,
3	Original Legal & Technical documents Pre-review	contact us	1-2 Months	1. Pre-review all Original Legal &Technical documents, and instruct Applicant to revise the gaps where are not met. Requirements of CFDA 2. Find out defects factors in the original Legal &Technical documents，Analyse its resulting risk of registration.
4	CFDA Application Dossiers Draft, Edit, Compile , Pre-review and Official Submit	contact us	3 - 5 Months	1. Draft and Compile all of CFDA application Dossiers (32 documents), base on the Original Legal & Technical documents provided by Applicant. 2. Find relevant expert for pre-evaluation when necessary, and ensure the completeness of dossiers. 3. Legal Document Chinese version Notarization: LOA, FSC, GMP,etc
5	NICPBP Drug Tests conduct & Follow up (Time controlled by NICPBP )	contact us	4- 6 Months	1. Prepare technical dossiers required for NICPBP tests. 2. Arrange NICPBP test and follow up the test procedure, 3. Communicate with NICPBP relevant officers to promote pass of testing.
6	CDE Technical Evaluation & Follow up ( Time is controlled by CDE ),	contact us	9- 12 Months	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.
7	Clinical Trials Permission CFDA Approval & Follow up	contact us	1-2 Months (Time controlled by CFDA )	Communicate with relevant officers, promote rapid and successful pass of clinical trial Permission Approval.
	Total:	contact us	2-3 years	Include the CFDA official charge & test cost.

Notes:

1． Abbreviations define: CFDA: China Food & Drug Administration ; CDE: Center forDrug 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.

GACC Search Tools

GACC HS code, CIQ code & Tariffs

GACC Approved Food Manufacturers List

GACC Registered Overseas Food Exporters

GACC Registered Food Chinesse Importers

GACC Registration Food Categorisation

China Permitted Food Ingredients

GACC-2-2 White List for Primary Agricultural Product

China National GB Standards for Food

Wechat	Whatsapp
	Not available in China

China GACC Registration - e-Service Center -

◄ Cost & Time for Drug China NMPA Registration (Clinical Trials Permission (CTP) Phase) ►

China GACC Registration
- e-Service Center -