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BIO Submits Comments on Draft EMA Guideline on Gene Therapy

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The Biotechnology Industry Organization (BIO) thanks the European Medicines Agency (EMA) for the opportunity to submit comments on the &ldquo;Guideline on the quality, non-clinical and clinical aspects of gene therapy medicinal products.&rdquo;</p>

The Biotechnology Industry Organization (BIO) thanks the European Medicines Agency (EMA) for the opportunity to submit comments on the “Guideline on the quality, non-clinical and clinical aspects of gene therapy medicinal products.”

BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial, and environmental biotechnology products.

This first draft is a helpful attempt by EMA at creating a unifying guideline supporting gene therapy medicinal products (GTMP) that also pulls together previous EMA guidelines that address specific aspects of gene therapy development.