Considering the current requirements for epidemic prevention and control and the need of innovative drug developments in China, the CDE (Center for Drug evaluation) of the NMPA (National Medical Products Administration) made an announcement on December 22, 2021, listing out the consultation arrangements with enhanced support of technical guidance and services provided to the applicants:
Inquiries related to key stages of drug development
According to the Administrative Measures for Communication and Exchange of Drug Development and Technical Review (No. 48-2020), applicants can apply for a video conference meetings for inquiries related to key stages of drug development. If a video conference meeting is considered not required by the authorities, a timely response will be written back to the applicant.
Applicants are recommended to utilize the online platform to make general inquiries. The CDE classifies inquiries as technical or non-technical. Technical questions will be answered within 15 working days, and non-technical questions will be answered within 10 working days.
Real-time consultation on matters related to registration applications
According to the requirements of epidemic prevention and control, CDE has adjusted the on-site consultation every Wednesday to telephone consultation. Applicants can call for real-time consultation. Every Monday, Wednesday and Friday, call 010-85243528 for review business consultation; Tuesday and Thursday, dial 010-85242306 for consultation about registrations.
Consultation on product management review
Applicants can contact the project manager by phone, and the contact information could be found on the official website. Otherwise, the project manager can be contacted by email and provide feedback to such inquiries within 3 working days.
Inquiry-based communication may be initiated by the review team so applicants should stay attentive to provide feedback as required.
By Yu fang. Contact Cisema if you would like to learn more.