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In order to thoroughly implement the decision-making and deployment of the Party Central Committee and the State Council on doing a good job in the "six stability" work and implementing the "six guarantees" task, support drug research and development, and promote the development of the pharmaceutical industry, it is decided to temporarily extend the time limit for supplementary information for drug registration applications, which is hereby announced as follows: 1.
For drug registration applications 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
.
This is hereby announced
.
NMPA October 14, 2022
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