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KMID : 1142220060010020043
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Regulatory Research on Food, Drug & Cosmetic
2006 Volume.1 No. 2 p.43 ~ p.50
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Pharmacovigilance-related Regulations and Guidances in Foreign Countries
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Lee Kwan-Sook
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Abstract
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International standards on pharmacovigilance (PV) have been already established in ICH E2 guidelines and each country has been developing their own PV system based on the ICH guidelines. In Korea, it is thought that regulations on clinical safety activities in drug development are for the most parts well harmonized with ICH guidelines on the basis of KGCP. However, for marketed products, due to considerable discrepancies between local regulations and ICH guidelines from basic concepts to actual practices, there is a strong need to reform current regulations in line with international standards. Through review of ICH PV-related guidelines which are based on the recommendations from CIOMS working group, I suggested several points to consider for application of each ICH guideline to local regulations, which include 1) focus on Adverse Drug Reactions, 2) standardization of individual case report forms and the data elements regardless of reporting source, 3) differentiation of reporting requirements for solicited vs. unsolicited sources, 4) improvement of current periodic safety reporting methodology (quarterly reports for all individual adverse event cases vs. introduction of PSUR). In addition, the PV systems in major countries, i.e. US, EU and Japan were reviewed on their harmonization or modification of ICH guidelines based on the situations in each country, in order to propose appropriate models to benchmark for setting up of new PV system in Korea. Lastly, to support good PV practices in pharmaceutical companies, I also emphasized the needs of detailed guidance and trainings for the drug safety-related personnel.
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KEYWORD
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CIOMS, ICH, pharmacovigilance, CIOMS, ICH, post-approval safety reporting
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