What’s New for Drug R&D and Evaluation Communication in China
Written by Jianqing Chang, Vice President of Drug Regulatory Policy, Tigermed Co., LtdEdited by Howard Fields
For drug research & development (R&D) and evaluation, it is essential to have communication between applicants and reviewers. To address those key technical issues not covered by the current drug R&D and evaluation guidelines, the Center for Drug Evaluation (CDE) issued The Drug R&D and Evaluation Communication Regulation recently, following the revision efforts initiated in December 2019 and public comments sought in April 2020. Compared with the previous version effective since October 2018, the communication procedures, requirements and situations are more optimized. The communication meetings are classified into three types.
Type I Meetings
The objective is to resolve major safety issues encountered during clinical trials and major technical issues encountered in the development of breakthrough therapeutic drugs, or other prescribed situations. Normally, once confirmed by the CDE, Type I Meetings are scheduled within 30 days after an application being filed.
Type II Meetings
Type II Meetings are generally to be held at the critical stages of drug development, such as pre-IND; end of Phase II and start of Phase III clinical trials; pre-NDA; and for risk assessment and control. There are three requirements: communication is legally required, communication shall be made, communication may be applied or not. Normally, once confirmed by the CDE, Type II meetings are scheduled within 60 days after an application being filed.
1)Communication is legally required for the application of conditional approval procedures and/or the application of priority review and approval procedures before the filing of a marketing authorization application.
2)Communication shall be made before applying for the first clinical trial of new drugs. Applicants shall submit applications for communication with the CDE to ensure the safety of trial subjects, the completeness of a clinical-trial application dossier and the feasibility of conducting the trial. Before applying for the marketing authorization of preventive and therapeutic biological products, applicants shall submit an application for communication with the CDE.
3)Communication may be applied in the process of drug clinical trials, including the key stages such as the end of phase II /start of phase III clinical trials, and before applying for marketing authorization of chemical drugs and TCM. Then, applicants may submit an application for communication with the CDE.
4)Communication may not be applied to those trials with clear technical guidelines and mature clinical trial experience, if applicants are capable of guaranteeing the quality of the application dossier, or if multi-regional clinical trials (MRCTs), simultaneous with global development, have been approved in countries and/or regions with sound administration systems. Applicants may file clinical trial application directly without communication in advance.
Type III Meetings
Type III Meetings refer those other than Type I and II. Normally, once confirmed by the CDE, Type III Meetings are scheduled within 75 days after an application being filed.
1)For new indications and clinical trials of new combination with other drug(s)
2)For critical technical issues in the development of drugs, to satisfy urgent medical needs or treatment of rare diseases
3)For major R&D issues related to complex generic drugs, such as consistency evaluation or re-evaluation
4)For complex and important non-clinical research (carcinogenicity research, etc.) protocol design.
5)For the inquiry or data supplementation requested by reviewers, if applicants have a different technical opinion and disagreement on the evaluation’s conclusion
6)For drugs with cutting-edge technology
7)For post-marketing variations related to issues not covered by the current regulations and guidelines
8)For safety assessment and risk management related to issues during the conducting of a clinical trial
9)Other situations such as post-marketing clinical trial design and so on
As to other ordinary technical issues that applicants need to verify or consult about, Applicants Window, telephone, fax, email, etc., are still in place. For all key technical issues in the process of drug R&D and evaluation, the above Type I, II and III Meetings are applicable. The consensus reached between applicants and reviewers can be taken as an important reference for R&D and evaluation.
Considering the review resources and industry development status, the CDE is optimizing communication and emphasizing the applicant's main responsibilities. With the construction progress of the technical guideline system and continuing clarification of technical requirements, the necessity of communication may be reduced, while the predictability of communication may be improved.