A milestone has been reached by the EU and US (MRA)
With the recognition by the US Food and Drug Administration (FDA) of Slovakia, the European Union and the United States have now fully implemented the mutual recognition agreement (MRA) for inspections of [...]
EMA’s quality guideline for drug device combinations
The European Medicines Agency (EMA) have released a draft guideline on the quality requirements for medical devices in human medicines that include a medical device, known as drug-device combinations, for a 3-month [...]
Medicinal cannabis now being made available under a pilot programme
Medicinal cannabis is being made available under a pilot programme. The pilot programme which allows access to cannabis-based products for medical use has been launched by the Minister for Health, Simon Harris. [...]
The Role Of The QP In Europe
Why do you need a QP? According to European regulations, no batch of medicinal product can be released for sale or supply prior to certification by a Qualified Person (QP). The QP [...]
The Role Of The QP In Europe
Why do you need a QP? According to European regulations, no batch of medicinal product can be released for sale or supply prior to certification by a Qualified Person (QP). The QP [...]
The EU-US Mutual Recognition Agreement Adds Luxembourg & Netherlands
The European Medicines Agency (EMA) announced on Tuesday that Luxembourg and The Netherlands have now joined the mutual recognition agreement for Good Manufacturing Practice (GMP) inspections between the US Food and Drug [...]
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