GMP News - Blood / Biologics and ATMP

A regular insight and overview of the activities around ATMP in Europe is provided by the reports on the CAT meetings, which list the latest news on classification, authorisation and much more.

Questions reaching us on the subject of COVID-19 vaccines, their development, approval and production, and on modern platform technologies used are answered in a summary.

During  2020, the FDA updated and expanded its series of guidelines on the topic of cell and tissue products with a revised version of the Guideline Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use.

Recently, the FDA published a Q&A Paper on their website that answers the most common questions about the emergency approval of COVID-19 vaccines and explains the underlying process.

In this Warning Letter from the FDA to a manufacturer of unauthorised tissue-based products, deficiencies in current Good Tissue Practice (cGTP) and violations of fundamental GMP regulations are described. 

By providing information on the safety of cell and tissue products in relation to coronavirus, the FDA gives support in questions of transferability by donors.

The FDA has revised its assessments and recommendations to reduce the possible risk of transmission of Creuzfeldt-Jakob by blood and blood products.