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Hanayuki Okura
Hanayuki Okura
Japan
Publications
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Review Article
History of Development and Regulations for Regenerative Medicines in Japan
Author(s): Hanayuki Okura and Akifumi MatsuyamaHanayuki Okura and Akifumi Matsuyama
Regenerative medicinal products were dealt with fewer than two categories only, pharmaceutical products and medical devices in the previous Pharmaceutical Affairs Law (PAL). Because regenerative medicinal products could not fully fit within the conventional regulatory contexts for pharmaceuticals, they were less available to the public. To overcome this issue, the Japanese parliament has legislated Laws for the Promotion of Comprehensive Measures to Facilitate Swift Distribution and Safe Use of Regenerative Medicines available to the Public (Regenerative Medicine Promotion Act). The Japanese government has changed the regulatory framework for regenerative medicinal products, 1) upgrading of directives for human stem cell-based clinical research to the Law concerning the Establishment of Safety of Regenerative Medicine Materials (Regenerative Medicine Safety Assurance Act), and 2) sett.. View More»
DOI: 10.4172/2157-7633.1000372