Regulatory Focus™ > News Articles > China: SFDA Issues New PSUR Guidance

China: SFDA Issues New PSUR Guidance

Posted 17 September 2012 | By Ansis Helmanis

New guidance on submitting periodic safety update reports (PSURs) for drugs was released by China's State Food and Drug Administration (SFDA) on 6 September.  The guidance conforms to the harmonized PSUR standards developed by the International Conference on Harmonization [ICH E2C (R1)].  Foreign importers and joint ventures must submit Line Listings, summary tables (Summary Tabulations) and the company's core data table (Company Core Data Sheet, CCDS) translated into Chinese, together with the original English text report.


Read more:

SFDA - Standardization of regular basis safety update reports

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