Major Positive News: CDE Issues for Public Comment the “Procedures for Accelerating the Review and Approval of Marketing Applications for Innovative Drugs (Trial)”!
Release Date:
2023-04-03 16:56
Just now, the CDE issued a notice soliciting public comments on the “Procedures for Accelerating the Review and Approval of Marketing Applications for Innovative Drugs by the Center for Drug Evaluation (Trial).” Details are provided below.
To encourage research and development of new drugs, meet clinical medication needs, promptly summarize and institutionalize the experience gained in the emergency review and approval process for anti-pandemic drugs, and accelerate the review and approval of innovative medicines, the Center for Drug Evaluation has drafted the “Procedures for Accelerating the Review and Approval of Marketing Applications for Innovative Medicines (Trial)” and is now making it publicly available on the Center’s website to solicit broad input and suggestions from all sectors of society. We welcome valuable comments and recommendations from all quarters and kindly request that such feedback be submitted promptly to our Center via the following email address.
Timeframe for soliciting comments: two weeks from the date of public notice.
Contact persons: Zhang Fan, Di Yunrui
Feedback email: jkss@cde.org.cn
Thank you for your participation and strong support.
Attachment: 1. “Procedures for Accelerating the Review and Approval of Marketing Applications for Innovative Drugs by the Center for Drug Evaluation (Trial)” (Draft for Comments)
2. Explanatory Notes on the Drafting of the “Procedures for Accelerating the Review and Approval of Marketing Applications for Innovative Drugs by the Center for Drug Evaluation (Trial)”
3. Feedback Form
Center for Drug Evaluation, National Medical Products Administration
February 21, 2022
Procedures for Accelerating the Review and Approval of Marketing Applications for Innovative Drugs by the Center for Drug Evaluation (Trial) (Draft for Comments)
This working procedure is formulated to encourage research and development of new drugs, meet clinical medication needs, and expedite the review and approval process for innovative pharmaceutical products.
I. Scope of Application and Review Time Limit
(1) Scope of Varieties: Applicable to Innovative drugs included in the Breakthrough Therapy Designation program 。
(2) Research and Development Stage: This stage applies from the completion of exploratory clinical trials, when the applicant is deemed to have met the conditions for conducting pivotal clinical trials, through to the approval for marketing. Under this procedure, no separate application by the applicant is required; innovative drug products that have been designated as breakthrough therapeutic drugs under the Breakthrough Therapy Designation Program shall automatically proceed with subsequent communication and review and approval activities in accordance with this procedure.
(3) Timeframe Requirements: The timeframe for communication and exchange is 30th , the review timeframe for variety approval is the same as that for priority-reviewed varieties: 130 days 。
II. Work Procedures
(1) Communication and Exchange
Applicants may, for varieties that fall within the scope of this procedure, follow Category I Conference (30 days) Submit a request for communication and exchange.
1. Communication and Exchange Related to Critical Clinical Trials
After completing the preliminary exploratory clinical trials, the applicant may submit a request for scientific consultation prior to and during the pivotal clinical trials, clearly identifying the critical technical issues that will impact the drug application and the associated supporting documentation, and submitting interim study data that comply with the format requirements for registration submission documents.
The Center for Drug Evaluation assembles review teams based on the specific characteristics of each product, taking into account departmental indication groupings, the nature of review tasks, and potential conflicts of interest among personnel. Each review team is responsible for the entire review process for a given product, from pre-submission communications and exchanges to technical evaluation following acceptance of the application. Such teams typically comprise review assessors, compliance reviewers, acceptance staff, and project managers.
At this stage, the Center for Drug Evaluation and the applicant discuss and reach consensus on the follow-up communication plan, the schedule for submitting interim study data, and the timeline for filing the marketing authorization application, among other matters. The applicant shall carry out the subsequent work in accordance with the agreed plan, while the Center will maintain ongoing communication and provide guidance to the applicant. In addition, the Center’s review personnel may engage at an early stage to guide the applicant in organizing the submission dossier in compliance with the relevant requirements.
2. Pre-NDA Communication and Exchange
Prior to submitting a marketing authorization application for a medicinal product, the applicant may submit a request for scientific advice and communication, clearly specifying the issues to be discussed and the relevant supporting documentation, and providing study data that comply with the format and content requirements for registration submission. Such requests for scientific advice and communication may be submitted after the preparation of the marketing authorization dossier has been completed on a single-discipline or multi-disciplinary basis.
The Center for Drug Evaluation shall, in accordance with the consultation questions submitted by the applicant, arrange for the review team to conduct a communication and exchange session and carry out a preliminary review of the supporting study data. The Center may provide feedback to the applicant on any issues identified in the current submission dossier; upon further supplementation and refinement, the applicant may re-submit a request for a communication and exchange session and submit additional information on a rolling basis.
In addition to addressing relevant technical issues, the review team shall conduct a preliminary examination of the batch approval documents’ attachments, including the manufacturing process information sheet, quality standards, package insert, and label draft. Reviewers shall notify the applicant of any significant deficiencies in these attachments. The applicant shall, prior to filing for marketing authorization, complete the necessary revisions in accordance with the review requirements and submit the revised attachments at the time of filing.
Depending on the specific circumstances of drug development, the applicant may agree with the Center for Drug Evaluation on a plan to submit additional information—such as longer-term efficacy and safety data—after the marketing authorization application has been submitted.
(2) Verification and Inspection
Prior to the formal marketing application, the applicant shall prepare in advance a complete set of CD-ROMs containing all submission materials for registration verification and inspection, including the R&D Information Form, Manufacturing Information Form, On-site Master File List, Clinical Trial Study Information Form, and Clinical Trial Information Summary Table, as well as quality standards and manufacturing processes (including manufacturing and testing procedures).
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