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Bill for consigned manufacture of advanced biologics

By Lee, Jeong-Hwan | translator Kim, Jung-Ju

24.02.05 12:05:38

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Rep. Hye-sook Jun submits bill to amend the Advanced Regenerative Medicine and Bio Drug Act as representative

¡®To allow MFDS approved institutions to outsource manufacture drugs...Strengthen patient access and domestic foundation for advanced regenerative medicine


A bill is being promoted to allow advanced biological products such as cell and gene therapies Kymriah and Zolgensma to be manufactured by government-authorized consignment organizations and facilities.

The goal of the bill is to expand the domestic production infrastructure for advanced biological products to reduce the time and cost of manufacture while increasing patient access to treatments.

Rep. Hye-sook Jun of the Democratic Party of Korea submitted a bill for the partial amendment to the ¡®Act on the Safety and Support for Advanced Regenerative Medicine and Advanced Biological Products¡¯ as representative.

Cell and gene therapies are highly complicated and expensi

Lee, Jeong-Hwan(junghwanss@dailypharm.com)
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