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Guidelines relevant for advanced therapy medicinal products
...The European Medicines Agency develops scientific guidelines to help pharmaceutical companies and individuals to prepare marketing-authorisation applications for human medicines. This page lists relevant guidelines for applicants for advanced therapy medicinal products. All of the below listed guidelines are available on the Agency's scientific guidelines pages as well as in the European ......
https://www.ema.europa.eu/en/human-regulatory-overview/advanced-therapy-medicinal-products-overview/guidelines-relevant-advanced-therapy-medicinal-products