Introduction


On July 27, China's National Drug Administration (CNDA) issued a notice on adjusting the review and approval process of clinical trials, which also means that China's Drug clinical trial filing system will be implemented.

In order to encourage innovation, accelerate the development of new drugs, meet people's demand for drugs, and see the applicant fulfills responsibilities as the subject in R&D, based on Opinions on Deepening Reform of the Review and Approval System to Encourage Innovation of Drugs and Medical Devices issued by General Office of the CPC Central Committee and General Office of the State Council, relevant procedures in the review and approval of drug clinical trials will be adjusted: If the applicant fails to receive the negative or questioning opinions from the drug review center under the CNDA within 60 days after the application is accepted and payment is made, the applicant may carry out drug clinical trials in accordance with the plan submitted.


The details are hereby announced as follows:


I. Preparation and application of communication meeting

(I) Before submitting the application for the first clinical trial of a new drug, the applicant shall apply to the drug review center for a communication meeting, and determine the completeness of the application materials and feasibility of implementing the clinical trial on the basis of ensuring the safety of the subjects.

(II) The materials prepared by the applicant for the communication meeting shall include clinical trial plan or draft plan, complete summary of existing pharmaceutical and non-clinical research data and other research data. The applicant shall evaluate on their own whether the existing research meets the basic requirements for the application of the proposed clinical trial and determine the issues to be discussed with the center.

(III) The applicant shall submit the application form for the communication meeting (Attachment 1) in accordance with the requirements of the Communication and Management Methods for Drug R&D and Technology Review (Trial) (hereinafter referred to as the "Communication and Management Methods"). The center shall inform the applicant whether to hold a communication meeting or not and negotiate the meeting time with the applicant. The applicant shall submit the complete communication meeting materials on time according to the relevant requirements of communication (Attachment 2). The center shall conduct a preliminary review of the materials for the communication meeting, and inform the applicant of the preliminary review opinions and the answers to the questions raised by the applicant through the "Applicant Window" website, at least two days earlier than the meeting time. The applicant shall give feedback as soon as possible on whether the questions have been explained after receiving the preliminary review opinions and answers. If the applicant considers that the problems have been solved and there is no need to hold a communication meeting, the applicant shall inform the center of cancellation of the meeting application through the "Applicant Window" website. However, if the problems fail to be solved in the view of the applicant, the meeting shall continue to be held as planned.


II. Convening of communication meeting

(IV) The meeting will be presided over by staff of the drug review center. The two sides will hold discussions on the key technical issues regarding the drug clinical trial program that are raised by the applicant, whether the existing materials and data support the implementation of clinical trials and whether the safety risks for the subjects are controllable, as well as put forward requirements and suggestions for follow-up studies.

(V) The meeting minutes shall be recorded according to the Communication and Management Methods. If the existing materials and data or the supplemented materials and data can support the clinical trial, the applicant may apply for the clinical trial after the communication meeting or after the materials and data are supplemented. If the existing materials and data are deficient, or the clinical trial program is incomplete or the risk control measures cannot guarantee the safety of the subjects in the clinical trials, the applicant shall analyze the reasons and carry out relevant researches. Meeting minutes shall be archived as review documents and used as reference for review and approval.


III. Acceptance and review of clinical trial applications

(VI) The applicant shall submit the application and application materials for the first clinical trial of a new drug in accordance with relevant requirements. For the application of the clinical trial of phase I, the information specified in Attachment 3 of this notice shall also be submitted.

The drug review center shall complete the formal examination within 5 days after receiving the application materials. If the application meets the requirements or meets the requirements after being supplemented in accordance with requirements, the center shall send a notice of acceptance.

The notice shall specify: within 60 days from the date of acceptance of payment, if no denial or questioning opinion is received from the drug review center, the applicant may carry out the clinical trial in accordance with the plan submitted.

When the clinical trial is launched, the applicant shall log in the website of the drug review center to register relevant information in the "Drug Clinical Trial Registration and Information Disclosure Platform".

(VII) If the application materials meet the review requirements, but there is relevant information to keep the applicant informed, the drug review center shall notify the applicant within 60 days after accepting the payment, specifying the relevant requirements and matters needing attention. The applicant should search and download the notice related to the clinical trial application through the website of the drug review center.

(VIII) If the accepted application materials do not meet the technical requirements of the review, the center shall inform the applicant of all the information that need to be supplemented and corrected in one time through communication or supplementary materials, and the applicant shall submit the supplementary materials in one time within 5 days after receiving the notification. If the applicant does not receive other denial or questioning opinions from the drug review center within 60 days after the supplementary information is accepted and the application is paid, the clinical trial can be carried out according to the plan improved. If the applicant fails to provide the supplementary information within the time limit or the supplementary information still fails to meet the review requirements, the drug review center shall notify the applicant by way of the notice to suspense the clinical trial, and specify the reasons why the clinical trial cannot be carried out yet.

(IX) If the application materials have major defects, or clinical trial scheme is incomplete, or reliable risk control measures is not prepared and a potential clinical risk is likely to happen which cannot guarantee the safety of the subjects in the clinical trial, the drug review center shall notify the applicant by way of the notice to suspend the clinical trial, and specify the reasons why the clinical trial are not supported yet. The center should communicate with the applicant before making the decision to suspend the clinical trial. The applicant should search and download the notice related to the clinical trial application through the website of the drug review center.

(X) After solving the problems pointed out in the notice to suspend the clinical trial, the applicant may submit a written reply and application to resume the clinical trial to the center. Within 60 days from the date of receiving the application, the drug review center shall give a reply on whether it agrees or not. The responses shall include opinions to allow to resume the clinical trial or to maintain the decision to suspend the clinical trial, with reasons. The applicant shall not carry out the clinical trial until a written approval letter is received from the center. If the applicant has objection to the notice to suspend the clinical trial and the dissent cannot be solved through communication, the applicant may apply for an expert consultation meeting or an open expert workshop.


IV. Related issues

(XI) If the application has definite technical guidelines and mature research experience has been gained in clinical trials and the quality of the application materials can be guaranteed, or the application is about the clinical trial that is undergoing R&D synchronously in international community with the participation of multiple international centers, and that clinical trials have been approved in countries and regions with sound regulatory systems, the applicant may apply for a clinical trial without communication.

(XII) For the clinical trial of new drugs has been approved, when phase I, phase II clinical trial have been completed and before phase III is implemented, the applicant shall apply to the drug review center for a communication meeting to discuss key technical issues of phase III clinical trial scheme. The applicant may also submit the application on key technical issues at different stages of clinical R&D.

(XIII) During the period when the clinical trial approved is being implemented, if the applicant wants to add a new indication, the applicant shall make another application for clinical trial or a communication application before the decision is made. In the case of a new application for a clinical trial, the materials that are duplicated with the first application may be exempted from submission, but the serial number of the relevant materials in the first application shall be listed in the application materials.

(XIV) For changes in clinical trial plan, major pharmaceutical changes and important non-clinical safety findings that may increase the safety risk on subjects, the applicant shall timely submit supplementary application in accordance with relevant provisions. The drug review center shall complete the technical review within the time limit, and notify the applicant to modify the clinical trial plan, suspend or terminate the clinical trial according to the technical review.

(XV) After obtaining the approval for the first clinical trial, the applicant shall regularly provide the drug review center with safety update reports during drug R&D, including global R&D and marketing status, ongoing and completed clinical trials, additional safety results, major production changes, overall safety assessment, summary of major risks, benefit-risk assessment, and next year's overall research plan, etc. It is generally submitted annually within two months of the end of each year after the drug has been approved for clinical trials. The center may request the applicant to adjust the reporting period according to the review situation. If the application fails to submit the report within the time limit, the applicant shall suspend the clinical trial of the drug.

(XVII) The applicant shall submit the materials and data needed for the review on time, ensure the quality, and accept the supervision and inspection of the R&D process by the supervision department.

(XVII) The applicant shall submit the materials and data needed for the review on time, ensure the quality, and accept the supervision and inspection of the R&D process by the supervision department.

(XVIII) The time limit specified in this notice shall be calculated by working days.

(XIX) The notice shall come into effect as of the date of promulgation. In case of any inconsistency between this notice and the previous one, this notice shall prevail.

It is hereby notified the above.

Attachments:

1. Application Form for Communication Meeting   

2. Requirements of Materials for Communication Meeting

3. Requirements of Application Materials for Phase I Clinical Trial of New Drugs

China's National Drug Administration

July 24, 2018

Notice:
Announcement of the China's National Drug Administration (CNDA) on Adjusting the Review and Approval Procedures for Drug Clinical Trials (No.50 of 2018)

HTTP://CNDA.CFDA.GOV.CN/WS04/CL2111/329716.HTML