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Quality, preclinical and clinical aspects of Gene Therapy medicinal products

Published by EMA

Advanced Therapy Gene Therapy Cell Therapy Non-Clinical Quality Genetically Modified Cell somatic cell clinical

Guide for the development and evaluation of Gene Therapy Medicinal Products (GTMPs) intended for use in humans and presented for Marketing Authorisation Application (MAA). Its focus is on the quality, Safety and efficacy requirements of GTMPs.

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Advanced Therapy Medicinal Products (ATMPs) Classification

Published by

Regulatory Affairs Early Access Support Advanced Therapy ATMPs Classification

Companies can consult the European Medicines Agency (EMA) to determine whether a medicine they are developing is an advanced therapy medicinal product (ATMP). This is an opportunity for ATMP developers to receive confirmation that a medicine, which is based on genes, cells or tissues, meets the scientific criteria for defining an ATMP. The procedure can help developers to clarify the applicable regulatory framework since the beginning of the product development.

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