Costanza Vignoli -

The European Medicines Agency (EMA) gives companies the opportunity to request the ATMP classification with the aim to confirm whether a product fulfils the definition of gene therapy medicinal product, somatic cell therapy medicinal product or tissue engineered product.

This procedure applies only to products based on genes, cells or tissues, as starting material, active substance or finished product including when combined with medical devices, bio-materials, scaffolds or matrices, and for which there are doubts as to whether or not they fall within the definition of an ATMP.

The relevant documentation needs to be prepared and sent to EMA, following the specific procedure timelines available on the EMA website.

The EMA’s Committee for Advanced Therapies (CAT) will deliver scientific recommendations on ATMP classification after consultation with the European Commission (EC) within 60 days after the receipt of the request.

The outcome of the assessment of the classification of ATMP will be published by EMA as summary reports.

Regulatory Pharma Net (RPN) has successfully supported companies in the early dialogue with EMA to optimize development in support of the targeted label indication and, to gain regulatory approval. RPN is ready to provide assistance with any early dialogue procedure including the ATMP classification request.

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