Advanced Therapy Medicinal Product (ATMP) | PharmaBharat Tools

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Advanced Therapy Medicinal Product (ATMP) | PharmaBharat Tools

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Biologics, Biosimilars & ATMPs(9)

Analytical Similarity Advanced Therapy Medicinal Product(ATMP)Biosimilar Center for Biologics Evaluation and Research(CBER)Gene Therapy Interchangeable Biosimilar Potency Assay 351(k) Pathway(351(k))Viral Vector

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RA Biologics, Biosimilars & ATMPsAdvanced Therapy Medicinal Product

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Analytical Similarity Biosimilar

Advanced Therapy Medicinal Product(ATMP)

Biologics, Biosimilars & ATMPs

Definition

EU category including gene therapy medicinal products, somatic cell therapy medicinal products, and tissue engineered products, regulated under specific EU legislation.

Regulatory source

Regulation (EC) 1394/2007