Chenghui Shuangda
In order to implement the requirements of the General Office of the CPC Central Committee and the General Office of the State Council on Deepening the Reform of the Review and Approval System to Encourage Innovation in Drug and Medical Devices, the General Administration of Food and Drug Supervision organized the drafting of the "Notice on the Adjustment of the Review and Approval of Drug Clinical Trials(Consultation Draft)". Comments and suggestions are sought publicly.
Relevant units and individuals are requested to provide feedback by e-mail by 14 January 2018.
In order to encourage innovation, speed up the creation of new drugs and meet public demand for drug use, according to the "Opinions on Deepening the Reform of the Review and Approval System to Encourage Innovation in Drug and Medical Devices"(No. 42, 2017), the General Office of the CPC Central Committee and the State Council optimized the examination and approval of drug clinical trials. Based on international experience, the review and approval procedures and methods of clinical trials are adjusted. The relevant matters are hereby announced as follows:
一、Preparation and application for communication meetings
（一）Before submitting an application for a clinical trial, the applicant may apply to the Drug Review Center of the State Food and Drug Administration(hereinafter referred to as the Drug Review Center) for a communication and exchange meeting to determine the integrity of the application materials for clinical trials and the feasibility of implementing clinical trials. The communication meeting materials prepared by the applicant should include clinical trial plans, complete summary of available pharmaceutical and non-clinical research data and other research data. The applicant should self-evaluate whether the existing research meets the basic conditions for reporting the implementation of clinical trials and clarify the issues discussed with the Drug Review Center.
（二） The applicant shall submit an application for a communication and exchange meeting in accordance with the requirements of the "Administrative Measures for Communication between Drug Development and Technical Review(Trial)"(hereinafter referred to as "Communication Measures")(Annex 1). The project manager of the Drug Review Centre shall agree with the applicant on the date of the communication meeting within 15 days of receipt of the application. The applicant should submit the complete communication meeting information 30 days before the formal meeting(Annex 2).
（三）The indications team of the Drug Review Center shall make a basic review of the communication and exchange meeting information, and shall inform the applicant of the preliminary evaluation opinions on the communication and exchange meeting information and the answers to the questions raised by the applicant at least 5 days before the communication and exchange meeting is held. If the applicant believes that the problem has been solved and there is no need to hold a communication meeting, the project manager should be informed through the "window of the applicant" of the website of the Drug Review Center that the communication meeting application has been withdrawn.
二、Holding of Communication Meetings
（四）The communication and exchange meeting shall be conducted according to the agenda of the meeting previously determined by the applicant and the project manager. The meeting was chaired by the project manager. The applicant and the drug-testing center's fitness review team should discuss the key technical issues raised by the applicant and whether the available data supports the implementation of clinical trials and whether the subject's safety risks are controllable. And put forward the request and the suggestion for the follow-up research.
（五）The minutes of the communication and exchange meetings shall be formed according to the requirements of the communication and exchange methods. The two sides reached a consensus that if the existing research data or supplemented and improved research data support the proposed clinical trial, the applicant can apply for a clinical trial after the communication and exchange meeting. If the existing research data have major defects, the clinical trial plan is incomplete or the lack of strict risk control measures can not guarantee the safety of the participants in the clinical trial, the applicant should analyze the reasons and carry out relevant research work. The minutes of the meeting serve as a file for the review documents and serve as an important basis for drug research and development, review and approval.
三、Acceptance, Review and Approval of Applications for Clinical Trials
（六）The applicant should submit the clinical trial declaration materials in accordance with the requirements for the application for data declaration in Phase I clinical trials of the new drug(Annex 1-3). The drug testing center completes the form review within 5 days after receiving the declared information. The notification of acceptance shall be issued in accordance with the requirements of the declaration, and the notice of acceptance states that if, within 60 days from the date of acceptance, no negative or challenging opinion is received from the drug examination center, the applicant may conduct a clinical trial according to the proposal submitted.
（七）The project manager and the team leader of the adaptation team shall formulate a 60-day review work plan and timetable for each professional work. The adaptation team should organize and complete the review as planned. After the adaptation team leader completes the review and submits the review report, it is signed by the Director of Clinical Review of New Drugs. Where there is disagreement during the review process, the new mechanism for the application of the drug as a target and the major public health problems are involved, it shall be submitted to the person in charge of the highest level post for issuance.
（八）If the applicant fails to receive the opinion of the drug examination center for challenge or denial within the prescribed time limit for examination and approval, the applicant may carry out a clinical trial of the drug according to the plan submitted. For meeting the requirements of the review, if relevant information needs to be reminded, the drug testing center shall notify the applicant by letter, indicating the relevant requirements and precautions.
（九）If the declared data does not meet the requirements of the evaluation, the Centre may inform the applicant by means of communication or additional information that the applicant shall make up the data within 60 days from the date of acceptance; If the applicant does not receive other negative or challenging opinions from the drug examination center within the prescribed time, the applicant may carry out drug clinical trials according to the improved plan; If the additional information does not meet the time limit or the additional information still can not meet the requirements of the review, the drug examination center shall notify the applicant by means of the notification of the approval opinion, stating that the reason for conducting the clinical trial is not yet available, and the application shall be terminated.
四、Other related matters
（十）Where the applicant has clear technical guidelines and mature research experience in drug clinical trials, or where the applicant is able to guarantee the quality of the declared data, or where the application for an international multi-center clinical trial has been jointly developed and approved for implementation in a country or region where the regulatory system is complete, Applicants can apply for clinical trials directly.
（十一）If a clinical trial has been approved, the applicant shall, after completing Phase I and Phase II clinical trials and before starting Phase III clinical trials, apply to the Drug Review Centre for a communication and exchange meeting to discuss with the Drug Review Centre the design elements of the Phase III clinical trial scheme.
（十二）Where clinical trials have been approved, applications for clinical trials to add new indications shall be submitted through supplementary applications. Research information in support of new indications should be submitted(Annex 3). Duplicate parts of the initial application may be exempted from submission, provided that the number of the relevant information in the first application is included in the declaration; For changing the clinical trial plan, major pharmaceutical changes, etc., which may increase the safety risk of the subject, an application for change should be made through supplementary application. The Drug Review Centre completed the technical evaluation of the supplementary application within 40 days.
（十三）After receiving the notification of opinions, the applicant may, after completing the relevant research and meeting the requirements for examination and approval of clinical trials, redeclare the application in accordance with the examination and approval procedures for new drug clinical trials. If there are objections to the notice of examination and approval opinions, an application for review may be filed, and if necessary, the drug examination center shall hold an expert consultation meeting to publicly demonstrate.
（十四）The applicant shall guarantee the quality of the declared data and accept the supervision and inspection of the R&D process by the supervisory authority.
（十五）As the resources for the review continue to grow, the time frame for the review will gradually align with the international context.
