Category Advance Therapy Medicinal Products (ATMPs)

EMA guideline on core SmPC, labelling and package leaflet for ATMPs containing genetically modified cells

Last updated: 2 October 2024 See update at the end of the post. The European Medicines Agency (EMA) issued a draft guideline in August for comments, on core Summary of Products Characteristics (SmPC), labelling and package Leaflet for ATMPS containing…

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EMA adopts guideline on quality documentation for medicinal products when used with a medical device

The European Medicines Agency (EMA) has adopted a guideline on quality documentation for medicinal products when used with a medical device. The guideline was adopted on 22 July 2021 and will come into effect on 1 January 2022. What is…

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EMA Q&A on the principles of GMP for the manufacturing of starting materials of biological origin for ATMPs

The EMA has published a Q&A on the principles of GMP for the manufacturing of starting materials of biological origin used to transfer genetic material for the manufacturing of Advance Therapy Medicinal Products (ATMPs). Is a GMP certificate required for…

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