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On October 14, the NMPA issued the Announcement on Temporarily Extending the Time Limit for Supplementary Information for Drug Registration Applications (No.
86 of 2022), deciding to temporarily extend the time limit for supplementary information for drug registration applications to support drug research and development and promote the development of
the pharmaceutical industry.
The main contents of the announcement include:
86 of 2022), deciding to temporarily extend the time limit for supplementary information for drug registration applications to support drug research and development and promote the development of
the pharmaceutical industry.
The main contents of the announcement include:
1.
For applications for drug registration under review that have been issued by the Drug Review Center of the State Food and Drug Administration but have exceeded the time limit for supplementary information, the time limit for supplementary information shall be extended by 80 working days
from the date of issuance of the announcement.
2.
For drug registration applications that have issued the Notice of Supplementary Information and are still within the time limit for supplementary information, the time limit for supplementary information shall be extended by 80 working days on the basis of the original time limit of 80 working days
.
3.
For drug registration applications issued by the Drug Review Center of the State Food and Drug Administration from the date of this announcement to December 31, 2022, the time limit for supplementary information is extended to 160 working days
.
