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

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【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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