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Cell & Gene Therapy Insights

Cell & Gene Therapy Insights

Regulatory Insight
Spotlight Article

Experiences from Japan: conditional and time-limited approval – an early approval scheme for regenerative medical products

Global Regulatory Update

Yoshiaki Maruyama, Masaki Kasai, Yasuhiro Fujiwara, Junichi Asano & Yasushi Jotatsu

In November 2014, the Pharmaceutical Affairs Law was revised and renamed the Pharmaceuticals, Medical Devices and Other Therapeutic Products Act (PMD Act). This Act provides the option of a new scheme to obtain conditional and time-limited approval for regenerative medical products. Giving patients better access to innovative medical products by providing the sponsor with generous regulatory and scientific support from an early development stage was also initiated in the USA in 2012 (Breakthrough Therapy Designation system) and 2017 (Regenerative Medicine Advanced Therapy (RMAT) Designation), and in the European Union in 2016 (PRIME; PRIority Medicines). As of April 2019, seven products have been approved in Japan and three of seven products have been approved through conditional and time-limited approval scheme. This review describes the detail for conditional time-limited approval scheme for the regenerative medical products, and the key consideration for this scheme from experiences of the Pharmaceuticals and Medical Devices Agency (PMDA) in review.

DOI: 10.18609/cgti.2019.064
Citation: Cell & Gene Therapy Insights 2019; 5(6), 561-568.
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