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KMID : 1142220210160020129
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Regulatory Research on Food, Drug & Cosmetic
2021 Volume.16 No. 2 p.129 ~ p.133
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Analysis of Drug Approval and Review Systems in Italy
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Kwon Sae-Woong
Kim Hee-Yoon
Song Yun-Kyoung
Weon Kwon-Yeon
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Abstract
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This study was to collect information on the drug approval and review process in Italy, and based on this, to compare and analyze the drug regulatory system between the Italian Medicines Agency (AIFA) and the Ministry of Food and Drug Safety (MFDS). To this end, information on clinical trial application, new drug application (NDA), generic drug application, renewal, pharmacovigilance, and fee information was systematically analyzed through the relevant laws, regulations, guidelines, and literature on the AIFA website. There were differences in the procedure and review period between the AIFA and MFDS in terms of procedures for drug approval application, required data, and drug subject to review period. There was also a difference in pharmacovigilance and risk management between the AIFA and MFDS, and fees for NDA were set up to 17 times higher in the AIFA than in the MFDS. The result of this study, which analyzed the AIFA’s drug approval and review systems, is expected to contribute to the expansion of domestic drug exports to Italy by enhancing the understanding of the AIFA’s drug approval and review system.
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KEYWORD
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Italy, Italian Medicines Agency, Human medicine, Drug Approval and Review Systems
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