New Japanese Regulatory Frameworks for Post-Marketing Management of Pharmaceutical Products
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PERSPECTIVE
New Japanese Regulatory Frameworks for Post-Marketing Management of Pharmaceutical Products Kento Takamura 1 & Keisuke Tachibana 1 & Tetsuya Kusakabe 2 & Kiyohito Nakai 3 & Yasuo Tsutsumi 1 & Masuo Kondoh 1
Received: 23 April 2020 / Accepted: 25 May 2020 # Springer Science+Business Media, LLC, part of Springer Nature 2020
ABSTRACT Dossiers on approved pharmaceutical products must be kept updated and current during the products’ life cycles. The coalition, merger and acquisition along with corporate strategy that pursues efficiency and profitability of pharmaceutical companies have led to the globalization of supply chains for pharmaceutical ingredients and instruments in the post-marketing phase, and progress in manufacturing technologies can improve manufacturing processes during this phase. Regulatory requirements for post-marketing management of pharmaceutical products sometimes differ among countries around the world depending on national/regional policies or situations, even though the basic concepts of each regulation are the same. Therefore, an understanding of upto-date region specific regulatory management frameworks is important for the optimal provision of pharmaceutical products by pharmaceutical industries. The amendment of the Japanese Pharmaceutical and Medical Device Act (Act No. 63 of 2019) was promulgated in December 2019, and will be enforced from September 2020 onwards. The amended Act sets out regulatory frameworks for post-marketing management systems, including inspection for good manufacturing practice of drugs, quasi-drugs, and gene-, cell-, and tissuebased products; and post-approval change-management protocols. Here, we review these new Japanese post-marketing management frameworks.
* Masuo Kondoh [email protected] 1
Graduate School of Pharmaceutical Sciences, Osaka University, Osaka 565-0871, Japan
2
Graduate School of Medicine, Osaka City University, Osaka 545-0051, Japan
3
Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare, Tokyo 100-8916, Japan
KEY WORDS good manufacturing practice . post-marketing pharmaceutical management system . regulation . regulatory framework
ABBREVIATIONS AR CBE GCTP GMP MAH MHLW PACMP PAS PMDA
Annual report Changes-being-effected Good gene, cellular, and tissue-based product manufacturing practice Good manufacturing practice Marketing authorization holder Ministry of health, labour and welfare Post-approval change-management protocol Prior approval supplement Pharmaceuticals and medical devices agency
INTRODUCTION Pharmaceutical products must be distributed nationwide stably and safely once they have been approved by the Japanese Ministry of Health, Labour and Welfare (MHLW). Marketing authorization holders (MAHs) have a responsibility to update approved dossiers to keep them up-to-date in order to appropriately manage the post-approval life cycles of such products. Regulatory frameworks are applied for managing pharmaceutical products after approval; such management includes ensuring c
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