Here, Snehit Satish Mhatre and Michael Timm of Eurofins discuss considerations and recommendations for the testing of live biotherapeutic products.
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European Directorate for the Quality of Medicines & HealthCare (EDQM)
The Council of Europe encourages EU Member States to share tissue and cell availability data to support donation access and State self-sufficiency.
The draft Regulation aims to enhance the protection of donors and recipients of substances of human origin (SoHO) therapies, while facilitating supply and innovation.
The EDQM will include Real-Time Remote Inspections (RTEMIS) as an integral part of its system for the supervision of manufacturers of active substances from 2022.
The European Directorate for the Quality of Medicines & Healthcare has announced three new guidelines outlining how to test the quality of COVID-19 vaccines.
The EMA has announced that metformin tablets from outside the EU do not contain unacceptable levels of NDMA impurities and EU metformin is not affected.