China

DCT Feasibility Assessment China The below version control table serves to document all updates made to the guidebook. The purpose is to ensure the information is always accurate and up-to-date. Disclaimers ...

This workbook provides an overview of the current and proposed regulatory landscape applicable in China in relation to Decentralized Clinical Trials (“DCT”). China abides by the regulations set forth by the National Medical Products Administrati...

2.1 Name of Regulatory Authority The National Medical Products Administration (NMPA) (the Chinese name translates as “State Drug Administration”) is the regulatory authority responsible for national drug registration management, which include...

3.1 Provide a list of documents needed to be submitted for EC/IRB review and approval including the number of copies and/or translations as relevant.  Each EC has its own application form and clearance requirements that can differ signific...

4.1 Provide a list of documents needed to be submitted for RA/CA review and approval including the number of copies and/or translations as relevant.  An overview of the documents required is presented below: https://globalregulatorypa...

5.1 Does local regulation require PI/CI to be approved/registered by any health authority (e.g., RA/EC)?   The Ethics committee is responsible for determining if the qualifications and experience of the investigator meet the requirements o...

6.1 Provide a list of documents needed for export permit relevant to biological specimen shipment. To obtain approval for new medication in China, all pharmaceutical companies need to perform studies on Chinese subjects. Many methods for both ...

7.1 eConsent/Remote Consent  The use of eConsent has become acceptable in China in the last 4 years and is allowed according to the new guidelines. 7.2 eSignature (including any requirement for a countersignature (e.g. PI, witness,...

8.1 What data privacy and/or technology regulations need to be complied with in order to run a trial in the countries of interest?  The PRC Personal Information Protection Law (PIPL) (A full translation) https://www.china-briefing.com/ne...

9.1 Clinical trial subject recruitment: Are digital advertisements (including social media streams such as TikTok) allowed and, if so, what regulations govern them  (including the language/claims used and whether or not the mention of open-...

10.1 Clinical Trial with Investigational Medicinal Product The procedure to obtain a CTA includes the following key steps: Formal review of the application by the NMPA's Administrative Services Centre. Technical review by the CDE, includin...

National Medicinal Products Administration (NMPA) (Chinese) National Medicinal Products Administration (NMPA) (English) National Institute of Allergy and Infectious Diseases ClinRegs Genohub Blog – International biological material shipme...

Not Applicable.