Case Study

Premier Insight 275: Streamlining Regulatory Submissions For A Novel Advanced Therapy Medicinal Product Trial

Europe iStock-490822468

The European regulatory landscape for advanced therapy medicinal products (ATMPs) is complex and the approval pathway depends on product classification. The EMA’s Committee for Advanced Therapies (CAT) is responsible for providing scientific recommendations on the classification of ATMPs as either gene therapy medicinal products (GTMPs), somatic cell therapy medicinal products (sCTMPs), tissue-engineered products (TEPs), or combinations thereof. However, product classification may not always be clear-cut given the proliferation of novel approaches to ATMP development.

Approval times for an initial clinical trial in Europe varied widely from fewer than 30 days to more than a year, with an average approval time of three to six months, according to a survey of Alliance of Regenerative Medicine members. These timelines vary widely by country and are longer for trials with gene therapies due to the additional regulatory submissions and permits required for products sub-categorized as genetically modified organisms (GMOs).


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