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KMID : 1142220130080010069
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Regulatory Research on Food, Drug & Cosmetic
2013 Volume.8 No. 1 p.69 ~ p.78
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Global Trends of Development and Evaluation of Medicinal Products - Focusing on ‘Whole Life-cycle Management’ Paradigm -
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Ha Ji-Hye
Lee Kyung-Sun
Na Han-Sung
Kim Young-Hoon
Shin Hee-Jung
Kim Hae-Deun
Seo Doo-Won
Choi Jong-Youl
Kim Ji-Yeon
Kim Jae-Hwan
Chung Myeon-Woo
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Abstract
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Since the paradigm of “whole life-cycle managements” -continuous risk detection·evaluation·management processes from development stage, through new drug approval, to post-marketing - has become the main topic of regulatory authorities' activities after 2000's, we searched and collected related systems, regulations and guidelines and analyzed them comparatively. To manage safety of medicines throughout life-cycle, drug regulatory agencies has reinforced the conventional pharmacovigilance activities (i.e. adverse events monitoring, periodic safety update report etc.) and introduced “REMS/RMP (risk evaluation and mitigation strategy/risk management plan)” system. For the soft landing of REMS and renewal system locally, the establishment of combined system between existing institutions such as re-examinations, re-evaluation etc. and new systems and the development of specific guidelines are urgently needed.
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KEYWORD
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whole life-cycle management, benefit/risk balance assessment, adverse event monitoring, REMS/RMP (risk evaluation and mitigation strategy/risk management plan), marketing authorization renewal
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