Procedures for Communication Meeting Between CDE and Drug. Registration Applicants. (Interim)

Transcription

1 The Center for Drug Evaluation, SFDA Procedures for Communication Meeting Between CDE and Drug Registration Applicants (Interim) I. The Procedures is developed with the view to regulate the management of Center for Drug Evaluation s communication meeting with the drug registration applicants (hereinafter referred to as communication meeting), and to ensure the quality and efficiency of the communication meetings. II. The communication meeting refers to the meeting organized for the discussions and exchanges on technical issues related to drug registration between the Center for Drug Evaluation (hereinafter referred to as CDE) and the registration applicants (hereinafter referred to as applicants). III. Management of communication meetings is under the responsibilities of the relevant review offices. IV. Communication meetings apply to the following three circumstances: (A) Where according to the needs of review, CDE takes the initiative to launch a communication with the applicants; (B) Where in accordance with relevant regulations, the applicants may take the initiative to request a communication with CDE, which generally including: 1. Where for registration application that is in line with the special approval procedures, there is a need to communicate on the key technical issues involved in the process of research and development; 2. Where there is a need to communicate on the key technical issues involved in the process of review and clinical trial of the application products under review; (C) Other issues where a communication meeting is needed. V. The communication meetings are generally held in the manner of face to face meetings, video or telephone meetings.

2 VI. Communication meetings proposed by CDE: 1. Discipline chief reviewer/chief reviewer reporter may propose communication meetings during the discipline review period, chief reviewer reporter s comprehensive review period or review period. The staff of the review office shall fill in the Approval Form for Communication Meeting with Registration Applicants (Annex 1), which shall be reviewed and approved by relevant review office and submitted to the office of review management; the office of review management or CDE leadership may also directly propose communication meetings (project managers are responsible for filling in Annex 1). The meeting application shall clarify the issues to be discussed, the demands of the participants, the materials to be submitted and other related contents. 2. The Office of Management and Communication is responsible for submitting the meeting applications to CDE leader (authorized person) for approval. 3. The Office of Management and Communication is responsible for organizing and arranging communication meetings within 1 month after approval, contacting the applicant via telephone, fax, mail, etc., informing the applicant of the issues to be discussed in the meeting, the materials to be submitted and the demands of the participants, and determining the date, place and other related matters of the meeting; and notifying relevant CDE personnel of the related arrangements prior to the meeting. 4. The review of the applications involved in the meeting may be suspended according to the CDE prescribed procedures, and the review shall be resumed the day after the meeting. 5. Relevant review offices are responsible for the meeting preparation and clarifying the discussion topics; fully communicating with the applicants during the meeting and reach a consensus or mutual understanding of each other's point of view on topics of the meeting to ensure the quality and efficiency of the communication meeting; and proposing solutions on related applications after the meetings in light of the discussion opinions. VII. Communication meetings proposed by the applicants: 1. The applicants shall fill out the Application Form for Communication Meetings with Registration Applicants (Annex 2), and submit the issues to be discussed and relevant research data with reference to the requirements of communication and exchange of Special Approval Process. 2. The office of review management, in conjunction with the review reporting offices/ review offices, is responsible for reviewing the meeting application submitted by applicants within one month, giving

3 opinions on whether the meeting is necessary, the issues to be discussed and the demands of the participants of both sides etc., which shall be submitted to CDE leaders (authorized person) for approval ( Annex 3: Approval Form for Communication Meetings with the Registration Applicants, which is filled by the project manager). (1) Where the communication meeting request is disapproved, the office of review management shall notify via telephone the applicants, and make telephone records that are to be archived together with the documents received. (2) Where the communication meeting request is approved, the office of review management shall notify via telephone the review offices and the applicants, and convene the meeting within one month after the approval, and send the detailed arrangements of the meeting by phone, fax, mail etc. to the applicants and relevant CDE participants prior to the meeting. 3. The review office which is responsible for convening the meeting shall inform the participants of the issues to be discussed in advance and make good preparation to ensure the quality and efficiency of the communication meeting. During the meeting, the review office shall fully communicate with the applicants to reach a consensus on the issues of the meeting or to understand each other s point of view to ensure the quality and efficiency of the communication. VIII. Requirements for the minutes of the meeting (A) Minutes shall be written for each meeting. (B) The minutes shall accurately and comprehensively reflect the meeting process, major topics and the achievement of desired objectives. (C) The minutes of the communication meetings proposed by CDE shall be drafted by discipline chief reviewer / chief reviewer reporter and reflected in the review reports. The meeting minutes along with the review reports shall be submitted to the office director. The minutes involving significant decisions shall be reported in accordance with the requirements of the Procedures for Review Decision-Making Pathways (Interim). Other CDE participants may have access to the review report and the meeting minutes through the online Review Information System. (D) Where the communication meeting is proposed by the applicants, the meeting shall be under the care of a person (usually the chief reviewer reporter / discipline chief reviewer) designated by the meeting organization offices. The minutes shall be drafted in conjunction with the applicants, and if necessary, opinions of the participants shall be collected. Once the minutes are confirmed with a consensus, they are to be signed by both parties (director of the organizing office from CDE side), and be fed back to the applicants and CDE participants respectively. (E) The minutes shall be archived together with the applicants

4 meeting request, the CDE s approval and other related documents, and filed timely in the CDE Meeting Minutes Management System for future reference and application in the follow-up study of new drug applications and reviews. IX. All relevant CDE personnel shall implement the Procedures accordingly. X. The Procedures shall enter into force as of the date of release. Annex: 1. Approval Form for Communication Meeting with Registration Applicants(filled by the staff of review office) 2. Application Form for Communication Meetings with Registration Applicants (filled by applicants) 3. Approval Form for Communication Meetings with the Registration Applicants (filled by project manager) Annex 1: Approval Form for Communication Meeting with Registration Applicants (filled by the staff of review office) Drug Name Accepted Number Registration Applicant Indications Review Reporting Office Chief Reviewer Reporter Registration Category Review Office Chief Reviewer Person of Proposing Office ( Signature )( Chief Reviewer Reporter/Chief Reviewer) The Issue to be Discussed Demand for Applicant s Participant Requirements for Materials Submitted Experts to be Invited(Name, Professional field,unit, Contact Information )

5 Opinions of Director of Proposing Office Opinions of Directors of Relevant Review Office Opinions of Office of Review Management Opinions of CDE Director (Authorized Person) Conditions Confirmed by Project Manager (Meeting Date, Venue etc.) Notes: Applicant Annex 2: Application Form for Communication Meetings with Registration Applicants (filled by applicants) Application Type Study Work Accomplished Issues to be Discu ssed Special review procedure Key issues for registration application undue review Drug Name Accepted Number Before clinical trial: CMC Pharmacodynamics Toxicolog y Clinical trial period: PhaseⅠ PhaseⅡ Phase Ⅲ summery and evaluation on periodic result of clinical trial protocol key safety issues revision of protocol indication adjustment strength adjustment others Issues to be Discussed and Relevant Materials Communication Patterns face to face meeting video meeting others

6 name unit title field Responsibility in the study Attendees Notes Applicant Unit(seal) Application Date Contact Person: Telephone: FAX: Address: Cell phone: Annex 3: Approval Form for Communication Meetings with the Registration Applicants (filled by project manager) Applicant Drug Name Opinions of Office of Management and Communication Opinion of Review Reporting Office Accepted Number Yes No Whether to have the communication meeting The Situation of Request from applicant: Yes No Is the issue to be discussed clear? Yes No Is the submitted material supportive for communication meeting Yes No Are the participants qualified for communication meeting Arrangement of the meeting: Meeting date: CDE attendees:

7 Opinions of Relevant Review Offices Opinions of Office of Review Management Opinions of CDE Director(Authorized Person) Conditions Confirmed by Project Manager (Meeting Date, Ven ue etc.) Notes: Disclaimer: This document is for reference only. For any dispute, the Chinese version shall prevail.