News

In a recent Warning Letter, FDA is criticising a Chinese company for their inappropriate identity testing.

The MRA with the USA was supplemented by two further countries: Poland and Slovenia. However some are still missing.

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.