article
Whole genome sequencing and analysis of live biotherapeutic products
Here, Snehit Satish Mhatre and Michael Timm of Eurofins discuss considerations and recommendations for the testing of live biotherapeutic products.
List view / Grid view
European Directorate for the Quality of Medicines & HealthCare (EDQM)
news
Sharing data on human tissue availability across EU
The Council of Europe encourages EU Member States to share tissue and cell availability data to support donation access and State self-sufficiency.
news
EU proposes new blood, tissues and cells Regulation
The draft Regulation aims to enhance the protection of donors and recipients of substances of human origin (SoHO) therapies, while facilitating supply and innovation.
news
EDQM remote inspections to become permanent part of inspection scheme
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.
news
EDQM releases new guidelines for COVID-19 vaccine quality testing
The European Directorate for the Quality of Medicines & Healthcare has announced three new guidelines outlining how to test the quality of COVID-19 vaccines.
news
EMA update: non-EU metformin medicines contain acceptable levels of NDMA
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.
