News

In the course of an inspection conducted in October 2018, the Italian health authority discovered several GMP deviations in the areas of sterile manufacturing, packaging and QC testing at an Italian manufacturer. Read more details about the Non-Compliance Report which can now be found in EMA's inspection database.

The US Food and Drug Administration (FDA) announced that it accepted four new states, which will now benefit from the EU-US Mutual Recognition Agreement MRA.

An inspection by EU inspectorates in collaboration with EDQM has revealed significant GMP violations at a Valsartan manufacturer's site.

The US FDA has published a so called internal Manual of Policies and Procedures (MAPP) describing how the agency will prioritise its pharmaceutical inspections.