Innovacell K.K. (Headquarters: Shibuya, Tokyo; Representatives: Colin Lee Novick, Jason David Sieger), which aims to improve people’s health and quality of life (QOL) through cell therapy for the treatment of fecal incontinence and urinary incontinence, is pleased to announce that its subsidiary, Innovacell AG (Innsbruck, Austria), has obtained the “Certification for Specific Cell Processing Products” under Article 39, Paragraph 1 of the Act on Securing Safety etc. of Regenerative Medicine from the Ministry of Health, Labour and Welfare as of September 7, 2022. This certification marks the first of its kind in Asia, excluding Japan.
For over 15 years, Innovacell AG has been engaged in contract manufacturing of specific cell processing products under GMP certification from the European Medicines Agency (EMA). Building on this experience, the company has now obtained the certification from the Ministry of Health, Labour and Welfare, enabling it to also undertake the manufacturing of specific cell processing products under Japanese regulations.
It is worth noting that under the Act on Securing Safety in Regenerative Medicine, only 10 facilities in South Korea, China, and Taiwan have received certification outside Japan, making this the first certification for a facility in Europe.
Innovacell will continue to strive to contribute to more patients through cell therapy.