The FDA has established guidelines since 2011, and Development Safety Update Reporting (DSUR) / Periodic Safety Update Report (PSUR) There are regulations that require reporting, and EMA has also been implementing PSUR regulations since 2011. Although there are some differences in Asia, Japan and China are already implementing it, while the Korean Food and Drug Administration is preparing to implement it from 2021. According to the Ministry of Food and Drug Safety (KFDA), by the end of this year (2021), a proposal (revision of laws) will be prepared, and after a certain period of probation, it will be mandatory from 2022 (distribution of guidelines in May, training by the end of the year). Is called.
References
News Article: Mandatory DSUR is imminent... Constraints "It's difficult, but I agree with the need for adoption"
Reporting of safety information for investigational drugs becomes mandatory from next year (the DSUR system is obligated to reflect international standards such as the Ministry of Food and Drug Safety)
FDA: FDA DSUR , FDA PSUR
EMA: EMA PSUR
MFDS: [Ministry of Food and Drug Safety] Drug Safety Management 2020 Implementation Plan
Software specialized for clinical trials JMP Clinical The latest version of is 8.0 (updated last November), reflecting new guidelines from various regulatory agencies such as FDA, EMA, PMDA, and opinions of reviewers, and is continuously updating the version. Especially in this 8.0 version Added DSUR/PSUR reporting function to quickly and efficiently generate up to 5 tables and 3 listings (shown below) that can be submitted to regulators Has been.
Detailed DSUR/PSUR-related functions in JMP Clinical can be found through the link below.
DSUR/PSUR report in JMP Clinical: Assess safety in ongoing clinical trials
Note: What's New in JMP Clinical 8.0
One. Adverse Event Narrative Summary
2. DSUR / PSUR Report
3. Medical Query Risk Report
4. Integration with JMP Live
Inquiries about JMP Clinical: daeyun.kim@jmp.com
Thank you.
