(P-346) Periodic Safety Reporting System for Post-market Drug Safety: A Comparative Analysis of Europe, United States, Japan and Korea

Background: Globally, the safety management of marketed drugs is actively strengthened through periodic benefit and risk assessments as part of pharmacovigilance. It is necessary to promote the international harmonization of the pharmacovigilance system by comparing and analyzing the current status of the period safety reporting system globally.

Objectives: The objective of this study was to compare the legislative system of periodic safety update reporting (PSUR) in the European Union (EU), the United States (US), Japan, and Korea.

Methods: We collected laws, guidelines, and reports related to periodic safety update reporting (PSUR) and periodic postmarket surveillance (PMS) reporting in the European Medicine Agency, the US Food and Drug Administration, the Japanese Pharmaceuticals and Medical Devices Agency, and the Korean Ministry of Food and Drug Safety. The system was analyzed and compared according to general information, target drugs, submitted materials, assessment and reporting cycles, reporting contents, review process and criteria, follow-up actions, and fees.

Results: In the EU and US, risk management plan (RMP), PSUR, and PMS were operated independently according to the complementary system, while PSUR in Japan was managed within the RMP and PMS systems operated independently. However, pharmaceutical companies in Korea should submit PSUR data as part of the RMP, and periodic PMS data should be also submitted separately. Drug categories subject to the submission were limited to new drugs, or drugs with different composition, administration route, or indications in Korea, and Japan, while in the EU and US, all approved drugs including generic drugs were subjected to the PSUR. There was an international incoherence in the assessment and reporting periods and review process, but the PSUR contents were harmonized among the countries.

Conclusions: In conclusion, it is necessary to harmonize periodic safety reporting system for post-market drugs internationally to support global drug development and pharmacovigilance.