G/TBT/N/CHN/1192  
 
10 January 2017  
(17-0146) Page: 1/2 
Committee on Tech nical Barriers to Trade  Original : English  
 
  NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member : CHINA  
If applicable, name of local government involved  (Article 3.2 and 7.2) : 
2. Agency responsible : China Food and Drug Administration  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification  shall be indicated if different from above : 
3. Notified under Article 2.9.2 [  ], 2.10.1 [  ], 5.6.2 [ X], 5.7.1 [  ], other : 
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable) : Drug. Medicaments 
(ICS: 11.120.10)  
5. Title, number of pages  and lang uage(s)  of the notified document : Administrative 
Provisions for Quality Control on Drug Clinical Trials (61 pages, in Chinese)  
6. Description of content : This notified document is drafted to strengthen  the quality 
control of  drug clinical trials, standar dize the process of drug clinical trial research, and 
ensure the data of clinical trial to be scientific, authentic and reliable so as to protect  the 
benefit and safety of subjects.  
This notified document contains 8 chapters and 81 articles, including Gene ral Principles, 
Institutional Review Board (IRB), Investigator, Sponsor, Clinical Trial Protocol, 
Investigators Brochure (IB), Essential Documents and Supplementary Provisions. 
According to the current administrative situation on drug  clinical tr ials and a fter fully 
considering international practices, the document further details responsibility of all parties 
related to drug clinical trials and sets up corresponding management requirements.  It 
emphasizes the scientific and ethical nature of clinical trials , focuses on the protection of 
vulnerable subjects, optimizes the composition of IRB and provides requirements on the 
frequency of follow -up reviews.  It also focuses on reports of Serious and 
Unexpected  Adverse Event, refines the requirements on source rec ords, adds investigator's 
oversight on research teams and third parties  providing services,  and strengthens 
sponsors  responsibility on risk -based quality control and oversight for outsourcing. 
Besides, the notified document stresses that methods used in qu ality control should match 
with trial risks and the importance of data collected, increases and refines the 
requirements on management of electronic systems, and clarifies the contents of IB.  
7. Objective and rationale , including the nature of urgent prob lems where 
applicable : Protection of human health or safety  
8. Relevant documents : – 
9. Proposed date of adoption : To be determined  
Proposed date of entry into force : To be determined   G/TBT/N/CHN/1192  
 
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  10. Final date for comments : 60 days after circulation by the WTO Se cretariat  
11. Texts available from : National enquiry point  [X] or address, telephone and fax 
number s and e mail and website address es, if available , of other body:  
WTO/TBT National Notification and Enquiry Center of the People's Republic of China  
Tel: +86 10 84603950/84603889  
Fax: +86 10 84603811  
Email : tbt@aqsiq.gov.cn   
https://members.wto.org/crnattachments/2017/TBT/CHN/17_0108_00_x. pdf