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KMID : 1011120140080020203
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Bioethics Policy Studies
2014 Volume.8 No. 2 p.203 ~ p.225
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A Study on Regulation (EC) No 1394/2007 on Advanced Therapy Medicinal Products in European Union
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Park Soo-Hun
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Abstract
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Advanced Therapy Medicinal Products(ATMPs) are medicinal products that can cure significant diseases and help regenerate functional weaknesses in human beings, including gene therapy medicinal products, somatic cell medicinal products, tissue engineering products, and combined ATMP. They are governed by Regulation (EC) No 1394/2007 on Advanced Therapy Medicinal Products enacted on November 13, 2007 and has been effective since December 30, 2008. This Regulation makes European Medicine Agency(EMA) yield regulatory powers to grant marketing approval for ATMPs through centralized authorization system. Therefore, through this centralized authorization system for ATMPs and a single regulatory agency called EMA in european union for approval of ATMPs, the Regulation may extend the use of ATMPs in european market by stimulating development and marketing approval of ATMPs. The Regulation laid down specific rules concerning centralized authorization, supervision, and pharmacovigilance of the ATMPs consisting of 8 Chapters, 30 Articles, and 4 Annexes. In addition, Committee for Advanced Therapies(CAT) has been established in EMA as a scientific advisory body based on the Regulation and gives advice to EMA on quality, safety, and efficacy on the requested ATMPs. The Regulation has some merits in that it can make people understand the existing regulatory frameworks on ATMPs and make the patients access to ATMPs more easily. However, the Regulation has been criticized due to some drawbacks such as sharing regulatory powers between EMA and Member States, entailing unequalness in accessing to ATMPs, allowing too much room for Member States to decide for themselves, not using risk-based approach properly, and having uncertainty on combined ATMP.
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KEYWORD
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Advanced Therapy Medicinal Products(ATMPs), Centralizedauhorization system, Committee for Advanced Therapies(CAT), European Medicine Agency(EMA), Regulation (EC) No 1394/2007 on Advanced Therapy Medicinal Products, Riskbasedapproach
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