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KMID : 1142220150100020181
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Regulatory Research on Food, Drug & Cosmetic
2015 Volume.10 No. 2 p.181 ~ p.187
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Drug Risk Management Plan in Korea
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Lim Sook
Kang Ju-Hye
Park Jae-Hyun
Kim Ho-Jung
Lee Sun-Hee
Choi Ki-Hwan
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Abstract
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The Risk Management Plan(RMP) is a document which is shown the consistent risk management of drug from the development phase to the post-marketing phase. Since July 2015, the Ministry of Food and Drug Safety (MFDS) has required RMP be submitted for all new chemical entities and orphan drugs, etc. The RMP includes the following four elements for individual drugs. 1) Safety specification: Important adverse drug reactions, which are clarified or suspected to the association with the drug, and important missing information. 2) Efficacy specification. 3) Pharmacovigilance Plan: plans for studies and other activities to gain more knowledge about the safety and efficacy of the medicine which are performed in post-marketing. 4) Risk minimization activities: Activities for safety measures taken to minimize the risks, which consists of medication guide for patients, information provision for healthcare professionals and elements to assure safe use, etc. The RMP covers the entire life cycle of the product. Therefore, it needs to periodically updated to reflect new knowledge of the product's safety profile and risk-benefit balance. The RMP will help patients and healthcare professionals to understand what types of risks are known for individual drugs at present. For the appropriate and safe use of medicines, it is important to understand the RMP, and to cooperate with MFDS, pharmaceutical companies, healthcare
professionals an patients.
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KEYWORD
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Risk Management Plan, RMP, MFDS
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FullTexts / Linksout information
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Listed journal information
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