药物研发与技术审评沟通交流管理办法-EN

Administrative Regulation on the Communication for Drug R&D Activities and

Technical Review

(Draft for Comment)

Chapter I General Provisions

Article 1This regulation is formulated for the purpose of good performance of communication and standardization of the communication between the applicants and the Center for Drug Evaluation of NMPA (hereinafter referred to as CDE), by following the principles of the Pharmaceutical Administration Law of the People's Republic of China, and Measures for the Administration of Drug Registration.

Article 2The communication, described in this regulation, is defined as the consultation and discussion applied by the applicants during the drug research and development process, through negotiation between the project management staff of CDE (hereinafter referred to as the “Project Manager”) and the drug registration specialist designated by the applicant, and approved by the review team of CDE, discussing the key technical issues that are not covered by the current drug R&D and review guidelines.

Article 3The forms of communication include: face-to-face

meeting, video conference, teleconference and written correspondence. Applicants are encouraged to communicate with CDE through teleconference. The proposal, consultation and conduct of the communication, as well as the preparation, convening, recording and minutes of relevant meetings, shall comply with this regulation.

Article 4The communication meetings stipulated in this regulation shall be applicable to the communication and consultation for the innovative drugs, modified new drugs, biosimilar drugs, Chinese herbal medicine compound preparation based on traditional classic prescription, drugs with the same name and prescription, complex generic drugs, and equivalency assessment drugs during their R&D process and registration applications.

Article 5Communication is an interaction process dealing with the technical issues between the applicant and the review team, during which both parties may fully present their respective viewpoints with regard to such issues.

Chapter II Types of Communication Meetings

Article 6Communication Meetings are divided into Class I, Class II and Class III meetings, at which the communication takes place in respect to major issues at key stages.

(I)Class I meeting is defined as the meeting held on the

purpose to address the major safety issues encountered during the clinical trials of drugs, and the major technical issues in the R&D process of the breakthrough therapeutic drugs, or held in other prescribed situations.

(II)Class II meeting is defined as the meeting held at the key stages of drug R&D process, which mainly include the following situations:

1.Pre-Clinical Trial Application meeting. To address major

technical issues before the first submission of the clinical trial application, the following issues can be discussed, including but not limited to: whether the available research data supports the proposed clinical trial; whether the risk of clinical trial subjects is controllable. The communication meeting materials prepared by the applicant shall include complete information on the clinical trial protocols or drafts, existing pharmaceutical and non-clinical study data, and other research data. For the clinical trial applications of the first global applications of the drugs with new mechanism and new structure, the applicant shall initiate the communication with CDE, and the technical requirements on the registration shall be established clearly.

2.End of Phase II clinical trial of drugs/Phase III pre-clinical

trial meeting. To address major technical issues encountered