Drug Regulators, EMEA, CHMP Publish Guidance on Follow-up Patients Adminstered with Gene Therapy Medical Products
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The initial clinical monitoring and follow-up after treatment with Gene Therapy (GT) medicinal products is described in the CPMP Note for guidance on the quality, preclinical and clinical aspects of gene transfer medicinal products (CPMP/BWP/3088/99). As for all medicinal products with new active substances, a risk management plan should detail the measures envisaged to ensure such follow up, with additional specificities for advanced therapy medicinal products described in the guideline on safety and efficacy follow-up – risk management of advanced therapy medicinal products (EMEA/149995/2008). The scientific principles of follow-up of the patients included in or after GT medicinal product trials, respectively, are also described hereafter. The authorization of gene therapy clinical trials is within the responsibilities of each EU member state (Directive 2001/20/EC). This guideline takes into consideration that the nature of the follow-up recommendations might vary depending on the risk profile of the gene therapy approach including the specificities of the GT medicinal product and of the transfer vector, the disease, co-morbidity and the patient target population and characteristics. With regard to the risk assessment of GT medicinal products, the data from non-clinical studies and early clinical studies as well as the data available in the public domain with similar products should be taken into consideration.
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