The European Commission issued a proposed regulation in November 2005 on Advanced Therapy Products aiming to provide the much awaited harmonized regulatory framework for cell-based products. This Regulation includes somatic cell therapies, gene therapies and also tissue engineered products (TEPs) in its scope and would close the regulatory gap as regards TEPs.
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When submitting and IND for CGT product/therapy, it’s crucial to confirm that the viral vector in use is appropriate, especially…
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In the ever-evolving landscape of pharmaceuticals/biopharmaceuticals, manufacturing changes play a pivotal role in ensuring the quality and effectiveness of medicinal…
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ATMPs (Advanced Therapeutic Medicinal Products) in Europe, or CGTs (Cell and Gene Therapies) as they are known in the US,…
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The recent announcement of BlueBirdBio to wind down its European commercialisation efforts due to access and pricing challenges for its…
