Good news: on October 14th, China’s National Medical Products Administration (NMPA) has announced an extra 80 to 160 days extension for the submission of drug supplementary dossiers to China’s Center for Drug Evaluation (CDE) for drug registration (No. 86 of 2022).
The temporary extension of the timeline for submission of supplementary materials for drug registration applications is good sign that the Chinese health authorities are supporting the development of Chinese pharmaceutical industry.
An 80 or 160 workdays extension has been granted for the following scenarios:
- 80 Days Extension:For drug registration applications that have received “Notice for Supplementary Materials” issued by CDE within or exceeded the time limit for submitting supplementary materials is granted an extra 80 workdays.
- 160 Days Extension:For drug registration applications that receive “Notice for Supplementary Materials” issued by CDE from the date of this announcement till December 31st of 2022, an extension of 160 workdays for submission of supplementary materials has been granted.
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We would be more than happy to arrange a teleconference call to share an overview of the China drug registration requirements, costs, and timelines. Email us to arrange a date and time to call (Info@accestra.com).