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Current status of pharmacovigilance regulatory structures, processes, and outcomes in the Asia‐Pacific region: Survey results from 15 countries
Author(s) -
Shin JuYoung,
Shin Eungyeong,
Jeong Han Eol,
Kim Ju Hwan,
Lee EuiKyung
Publication year - 2019
Publication title -
pharmacoepidemiology and drug safety
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.023
H-Index - 96
eISSN - 1099-1557
pISSN - 1053-8569
DOI - 10.1002/pds.4717
Subject(s) - harmonization , medicine , pharmacovigilance , environmental health , asia pacific , international trade , adverse effect , business , pharmacology , physics , acoustics
Purpose Regulatory discrepancies may exist in pharmacovigilance (PV) structure, process, and outcome status worldwide. Our study's objective was to survey the current status of PV in each regulatory body in the Asia‐Pacific Economic Cooperation (APEC) region. Methods A modified questionnaire was sent to the PV team heads of 21 PV agencies based in the APEC countries, between June 28 and September 12, 2017, to gather information on the structure, process, and outcome of PV status in these countries. Results Of the 21 APEC countries, 15 responded. We found harmonized laws and regulations for general PV and risk management systems. However, variations were found in PV structure: for example, 11 out of 15 countries had national regulatory representatives responsible for PV in pharmaceutical companies, while four did not. For PV process, discrepancies were also found in the source type of adverse drug reaction (ADR) reports and reporting of medication errors and therapeutic ineffectiveness in cumulative ADR reports. With respect to PV outcomes, among countries that performed active surveillance, the United States of America was more active, with hundreds of projects including additional pharmacoepidemiological studies etc. Among the nine countries that responded, Japan had the greatest number of product label changes followed by Taiwan, Malaysia, and Korea. Conclusion We have identified substantial variations in the structures, processes, and outcomes of PV status among the countries of the APEC region. Therefore, efforts to reduce variations in the PV administration and regulation are warranted for harmonization of PV within the APEC region.