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Pharmaceuticals / Postmarket Safety

EMA Drafts ‘Strengthened’ Guidance on Safety Follow-Up for Advanced Therapies

Feb. 6, 2018

The European Medicines Agency released a draft revised guideline for safety and efficacy follow-up of advanced therapy medicinal products, including gene therapies, cell therapies and tissue engineering.

The draft strengthens and clarifies EMA’s 2008 guidance, including more details on designing post-authorization safety and efficacy follow-up studies.

Applicants need to provide safety and efficacy follow-up data to support marketing authorization applications, including long-term data to analyze the benefits and risks of products in line with ATMP regulations.

Sponsors should define objectives for long-term safety follow-ups, based more on specific characteristics of these products than on the product classification, such as if it is cell based, gene therapy based or a combined ATMP.

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