Kiadis Biopharma granted the EMA's fifth Advanced Therapy Medicinal Product certification
Amsterdam, Netherlands-based biopharma company Kiadis has received an Advanced Therapy Medicinal Product certificate from the European Medicines Agency for its lead product ATIR, for blood cancers.
The ATMP certificate was issued based on a recommendation from the Committee for Advanced Therapies of the EMA that recognized the data generated for ATIR meets the high standards imposed by the agency. As of 2009, only five ATMP certificates have been issued by the regulator.
The certification procedure aims to gather a full evaluation of the complete manufacturing quality and preclinical data package ahead of marketing authorization.
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