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REGLEMENTAIRE
Le développement de la filière France bioproduction est assujetti à la réglementation; c'est aussi l'un des GROUPES de TRAVAIL de France Biolead
Latest articles
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Cycle de développement réglementaire et définitions
December 2, 2024
La filière de production des biomédicaments est une industrie réglementée, le réglementaire occupe donc une place prépondérante dans les activités....
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Biotech Act : public consultation
October 6, 2025
Une opportunité majeure pour la filière européenne des biotechnologies ; La Commission européenne prépare le Biotech Act, une future législation...
Actualité
ACTUALITES DE LA FILIERE BIOPRODUCTION
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Replay : roundtable "Biotech Act"
November 7, 2025
Discover the key discussions from the round table on the Biotech Act, a moment of insight and dialogue on this future European legislation that will...
Événement
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EVENEMENTS
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Equipment for manufacturing autologous cell therapies: ANSM approves France BioLead's recommendation
November 25, 2025
Good news for developers of cell therapy equipment: the ANSM has validated the position defended by France BioLead and confirmed that this equipment...
Actualité
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Biotech Act: understand the essentials in just a few minutes
February 24, 2026
On 15 December 2025, the European Commission submitted its proposed regulation under the Biotech Act. This is a landmark text for the future of our...
Actualité
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Replay Biotech Act roundtable
November 7, 2025
France BioLead organized a round table discussion with the participation of the DGE, AIS, SICOS, and LEEM, as part of the Biotech Act and public consultation.
EVENEMENTS
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Position FBL - Pharmacien Responsable
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Position FBL : Médicaments de Thérapies Innovantes
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Position FBL : Micro-Organismes et Toxines hautement pathogènes (MOT)
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Biotech Act
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Biotech Act: understand the essentials in just a few minutes
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For a revision of the Micro-Organisms and Toxins (MOT) regulatory framework, more proportionate to risks while maintaining a high level of safety, in line with emerging public health challenges (March 2026)
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