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KMID : 1142220200150020105
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Regulatory Research on Food, Drug & Cosmetic
2020 Volume.15 No. 2 p.105 ~ p.115
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A Study on Post Marketing Regulatory Information in Malaysia from the Perspective of Domestic Pharmaceutical Product Exports
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Kim Yong-Gyun
Kim Ji-Ae
Kwon Kyeng-Hee
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Abstract
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Korean pharmaceutical industry needs to be noted for its continuous increase in exports. Exports of pharmaceutical products to Malaysia can be a bridgehead for the Halal market to enter the Muslim market, making it a strategic country to contribute to the expansion of pharmaceutical product exports. However, the information on the post-market surveillance regulations is insufficient even though The APEC Harmonization Center has published a guidebook for drug approval of Malaysia in 2016. In this article, the post-market surveillance and the regulatory information in Malaysia was collected and reviewed using the Malaysian laws and regulation, guidelines and foreign announcements through the method of by investigating the related websites provided by Malaysian regulatory agencies. Malaysia has established the regulations and legal basis for postmarket surveillance, adverse drug reactions (ADRs) reporting system, regular benefit-risk assessment reports (PBRERs), and risk management plans (RMPs). In addition, as part of safety communication in Malaysia, regulations with regards to a direct healthcare professional communication (DHPC), a consumer medicine guide (RiMUP), and a box warning were also prepared. In the future, it is necessary to establish an export strategy that reflects the regulatory information which covers the whole life-cycle of the process of medication approval when exporting Korean pharmaceutical product to Malaysia.
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KEYWORD
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Malaysia, Post-Marketing Surveilance, Regulatory Information, Export
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