View : 74 Download: 0

How Does "Regulatory Practice" Create Discrepancies in Drug Label Information Between Asian and Western Countries? Different Label Information for Direct Oral Anticoagulants Approved in the United States, Europe, Korea, and Japan

Title
How Does "Regulatory Practice" Create Discrepancies in Drug Label Information Between Asian and Western Countries? Different Label Information for Direct Oral Anticoagulants Approved in the United States, Europe, Korea, and Japan
Authors
Cho, Il YoungChoi, Ki HwanSheen, Yhun Yhong
Ewha Authors
신윤용
SCOPUS Author ID
신윤용scopus
Issue Date
2019
Journal Title
THERAPEUTIC INNOVATION & REGULATORY SCIENCE
ISSN
2168-4790JCR Link

2168-4804JCR Link
Citation
THERAPEUTIC INNOVATION & REGULATORY SCIENCE vol. 53, no. 2, pp. 233 - 242
Keywords
regulatory authorityreviewreview standardriskbenefitdouble thresholdglocal
Publisher
SAGE PUBLICATIONS INC
Indexed
SCIE; SCOPUS WOS
Document Type
Review
Abstract
Globalization of the pharmaceutical industry has continued over the past few decades, and various regulatory authorities have put considerable effort into harmonizing and standardizing drug regulations. However, the regulatory practices of each regulatory authority, in addition to local differences in ethnic, social, and cultural backgrounds, create discrepancies in risk/benefit assessments, regulatory decisions, and drug label information in various countries. This study examines discrepancies in the label information for direct oral anticoagulants approved in the US, Europe, Korea, and Japan and reviews the causes of those discrepancies, focusing on regulatory practices. Although the label information for each direct oral anticoagulant in all 4 regions was supported by the same global, pivotal clinical data, it differed depending on regulatory authorities' judgments about the risk/benefit balance, which were based on their own requirements, regulations, perspectives on making regulatory decisions, and regulatory approval experiences, in addition to their review of the scientific data. In particular, the Korean Ministry of Food and Drug Safety and Japanese Pharmaceuticals and Medical Devices Agency have taken a comparatively conservative stance, with more emphasis on safety than on efficacy compared with regulatory authorities in western countries, because of the double threshold in their regulatory practice. Our findings suggest that drug label information in various regions will not be equal as long as differences in regulatory practice and non-regulatory factors exist among regulatory authorities. Also, those differences should be considered in order to streamline global drug discovery, development, and approval.
DOI
10.1177/2168479018769301
Appears in Collections:
약학대학 > 약학과 > Journal papers
Files in This Item:
There are no files associated with this item.
Export
RIS (EndNote)
XLS (Excel)
XML


qrcode

Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.

BROWSE