2020/12/18

Yakuji Nippo

Recurrence Prevention Measures for the SMA Drug Issue - Including Pre-evaluation of Application Data Committee on Regenerative Medicine Products and Biotechnology of Pharmaceutical Affairs and Food Sanitation Council


株式会社薬事日報社から許諾を受けて、株式会社シーエムプラスが英語に翻訳しております。
オリジナルの正式言語は日本語であり、内容および解釈については日本語が優先されます。
With permission from Yakuji Nippo, Limited, CM Plus Corporation translated into English.
The original article is authored in Japanese, and the Japanese shall prevail in meaning in terms of content and interpretation.

【Pharmaceutical Affairs and Food Sanitation Council】
Recurrence Prevention Measures for the SMA Drug Issue - Including Pre-evaluation of Application Data
Committee on Regenerative Medicine Products and Biotechnology of Pharmaceutical Affairs and Food Sanitation Council

December 07th, 2020

■Approved by Pharmaceutical Affairs and Food Sanitation Council

On December 3, 2020, the Committee on Regenerative Medicine Products and Biotechnology, Pharmaceutical Affairs and Food Sanitation Council generally approved the recurrence preventive measures compiled by Novartis Pharma K.K. after the delay in the approval of its "Zolgensma Intravenous Infusion" indicated for the treatment of spinal muscular atrophy (SMA) due to its improper response. The measures have included prevention of data falsification through prior evaluation of assurance of reliability of application data.

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