medicines-medical devices-regulatory affairs
Last updated: 27 January 2023 See update(s) at the end of the post. This post is an attempt to provide basic information on CAR-T cell therapy. The information is by no means exhaustive and can be used a starting point…
Last updated: 1 September 2023 This post is an attempt to provide an information resource for Advance Therapy Medicinal Product (ATMPs) in the EU. The information provided is by no means exhaustive. Click on the ‘+’ sign next to each…
The European Medicines Agency (EMA) has issued a draft guideline for comments, on core Summary of Products Characteristics (SmPC), labelling and package Leaflet for ATMPS containing genetically modified cells. What is the legal basis of the guideline? This guideline should…
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…
The EMA has published a Q&A on the principles of GMP for the manufacturing of startingmaterials of biological origin used to transfer genetic material for the manufacturing ofAdvance Therapy Medicinal Products (ATMPs). Is a GMP certificate required for manufacturing and…