EU Regulation (EC) No 1394/2007 - Advanced Therapy Medicinal Products

What it says

This Regulation lays down specific rules for advanced therapy medicinal products, which include gene therapy medicines, somatic cell therapy medicines and tissue engineered products. They are authorized centrally, are assessed with the involvement of the Committee for Advanced Therapies, and are subject to requirements for traceability, pharmacovigilance and follow-up of efficacy and adverse reactions.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• These products often involve living cells or vectors, which makes manufacturing and traceability demanding.
• Traceability from donor to patient must be kept for a long period.
• A hospital exemption exists for some products prepared in a hospital, under defined conditions.

What inspectors look for

• Whether traceability systems link donor, product and patient.
• Whether manufacturing controls suit the product's risks.
• Whether post-authorization follow-up is in place.

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