4. Regulatory Authority (RA)/Competent Authority (CA)
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4. Regulatory Authority (RA)/Competent Authority (CA)
- 3 Mins to read
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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:
4.2 Time required for RA/CA review and approval process and turnaround time if any query is raised during the review process.
4.3 Does the regulation support electronic submission?
No.
4.4 Does the regulation require the applicant to be Principal Investigator (PI)/Chief Investigator (CI)?
Foreign sponsors, with no presence in China, should appoint a local representative in China, called Marketing Authorization Holder (MAH), that should submit the CTA to NMPA on their behalf and provide the appropriate support till CTA approval. This does not need to be the PI – typically it is a local CRO.
4.5 Please describe the process of RA/CA submission for clinical trial approval.
Before submitting a CTA to NMPA’s Center for Drug Evaluation (CDE) for review, it is highly recommended to have a pre-consultation meeting with NMPA, to confirm the information and data to be included in the clinical trial application and the feasibility of the clinical trial in China. The review process of CTA by NMPA normally takes 65 days, excluding the clock stops due to NMPA queries. Sponsors not receiving feedback from NMPA after 65 days, can consider their CTA approved and can start the conduct of the clinical trial in China after receiving the approval from the ethics committee (EC).
Under the CFDA’s Adjustment on the Review and Approval Procedures for Clinical Trials for Pharmaceuticals issued in July 2018, the CFDA now adopts a negative notification system for the CTA in place of the previous positive approval system, shortening the time for the CTA from the previous 6-18 months to 60 business days. Furthermore, a communication mechanism was established between applicants and the Centre for Drug Evaluation (the department within CFDA that reviews and approves drug applications and grants CTAs) before and throughout the application. The process can be summarized as follows:
- An applicant should file a meeting request with the CDE regarding the feasibility of a trial, submitting materials including a draft trial protocol and all pre-clinical data.
- The CDE experts will review the materials and raise comments and questions.
- The applicant may cancel the meeting request if s/he believes all issues raised in the CDE comments have been resolved, or s/he can continue with the meeting request if there is a need for discussion.
- The applicant may discuss key technical issues with the CDE experts in a meeting and decide if s/he is ready to conduct the trial.
- The applicant may then file an application for the CTA.
- The CDE will make a formality review within five days and issue a notice of acceptance.
- The applicant can proceed to do the trial directly if s/he does not receive negative comments from the CDE within 60 business days.
- The CDE will raise negative comments if it finds that the materials fail to meet technical requirements, and the applicant will be given a chance to supplement materials to address the issues raised; the applicant can proceed with the trial directly if s/he does not receive negative comments within 60 business days thereafter.
- If the applicant fails to supplement materials to meet the technical requirements, the CDE will issue a notice to suspend the trial.
- The applicant can apply to continue the review and approval process after it has resolved the issues raised by the CDE.
4.6 Does the RA/CA provide written acknowledgment of the submitted application? If not, describe how the application is tracked.
Yes. NMPA will acknowledge receipt of the application and the date of application for tracking purposes.
4.7 What is the relevant RA/CA fee in local currency/USD? Please provide as much information as possible (e.g. if the fee is different for notification/approval, initial submission, amendment, study with IMPD and study without IMPD, etc.)
NMPA charges the following drug registration fees to review and approve clinical trials as part of the drug registration process:
- New drugs made in China: 192,000 Renminbi
- New drugs made outside China: 376,000 Renminbi
- Generic drugs made in China: 318,000 Renminbi
- Generic drugs made outside China: 502,000 Renminbi
https://www.nmpa.gov.cn/yaopin/ypggtg/ypqtgg/20150527192201777.html
4.8 Does RA/CA accept checks or can payment be made electronically? Please provide details on (1) A/C number; (2) A/C Name; (3) Sort Code; (4) Swift Code; (5) Bank address, etc. Where can remittance advice notices be sent?
Payment is made electronically.
4.9 Is there any guidance tool available for making an electronic application? If yes, provide the link and/or step-by-step instructions.
No, there is no guidance for online applications.
4.10 Does RA/CA require any screenshots/mock screens for participant-facing materials?
No.
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