EMA committee accepts non-clinical data in advanced medicine assessment

Published: 16-Oct-2013
Regulatory

When discussing a medicine containing autologous skeletal-muscle-derived cells


The Committee for Advanced Therapies for the European Medicines Agency (EMA) has for the first time formally accepted non-clinical data within a market authorisation application for an advanced-therapy medicinal product.

The committee made its decision when discussing a medicine containing autologous skeletal-muscle-derived cells that is intended to treat female stress urinary incontinence. This is the first advanced therapy medicine application to include non-clinical as well as quality data, said EMA.

Under its procedures, the committee can review non-clinical study (such as toxicology, carcinogenicity and pharmacology studies) and decide whether they can be taken into account when assessing a medicine’s safety.

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