Posts with tag ATMPs

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SOHO ALERT: A Comprehensive Guide to the Proposed Regulation on Substances of Human Origin – interplay with the Advanced Therapy Medicinal Products (‘ATMP’) Legislation
Legislative process On 19 July 2022, the European Commission (‘EC’) submitted a proposal for a Regulation on standards of quality and safety for substances of human origin intended for human application (‘SoHO Proposal’) to enhance safety standards for human substances, repealing the current Blood, Tissues and Cells (‘BTC’) legislative framework. The Current BTC legislative framework consists of the Blood Directive (Council Directive 2002/98/EC of 27 January 2003 setting standards of quality...
May 8, 2024
6 min read
Changes afoot for Belgian manufacturers of allogeneic...
Last month, the Belgian Parliament voted in favour of a set...
December 11, 2018
5 min read