Posted by Michael Wonder on 20 Apr 2020
Update to guidance on regulatory expectations in the context of COVID-19 pandemic
20 April 2020 - The European Commission, EMA and the national competent authorities have agreed a series of measures to mitigate the impact of disruptions caused by COVID-19 on the conduct of inspections of manufacturing facilities or other sites relevant for medicinal products in the European Union.
Current national and international safety measures and travel restrictions affect or prevent the conduct of on-site inspections related to good manufacturing and distribution practice.
The mitigation measures have been taken to ensure the continued availability of medicines while making sure that good practice standards are being adhered to.
