임상시험 정기적 안전성 정보보고(DSUR)?

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The FDA has established guidelines since 2011 and has been used for pharmacovigilance. Development Safety Update Reporting (DSUR) / Periodic Safety Update Report (PSUR) Regulations mandating reporting are in effect, and EMA has also been enforcing PSUR regulations since 2011. Although there are some differences in Asia, Japan and China are already implementing it, while the Korean Ministry of Food and Drug Safety is preparing to implement it from 2021. 2021 by the Ministry of Food and Drug Safety. 5. On the 12th, the laws related to the latest safety information reporting (ICH DSUR) for investigational drugs were revised. According to the Ministry of Food and Drug Safety, the DSUR system is a system that collects and evaluates and regularly reports safety information such as literature, non-clinical and clinical data for clinical investigational drugs, and is currently revising sub-regulations of the Pharmaceutical Affairs Act with the goal of mandatory implementation in 2022. is being promoted.

References

News article: DSUR mandatory imminent… Pharma “It is difficult, but we agree on the need for introduction”

Safety information reporting for clinical investigational drugs will be mandatory starting next year (DSUR system will be mandatory, reflecting international standards such as the Ministry of Food and Drug Safety and ICH)

FDA: FDA DSUR , FDA PSUR

EMA: EMA PSUR

MFDS: [Ministry of Food and Drug Safety] 2020 implementation plan for pharmaceutical safety management

Latest Safety Information Report for Investigational Drugs (ICH DSUR) (Civil Complainant Guide) - 2021. Established on 5.12

Software specialized for clinical trials JMP Clinical The latest version is 8.0 (updated in November last year), and we are continuously updating the version to reflect new guidelines from various regulatory agencies such as the FDA, EMA, and PMDA, as well as opinions from reviewers. Especially in this version 8.0 Added DSUR/PSUR reporting capabilities to quickly and efficiently generate up to five tables and three lists (see figure below) for submission to regulators. It is done.

Detailed functions related to DSUR/PSUR 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 regarding JMP Clinical: daeyun.kim@jmp.com

thank you