EU-US MRA on GMP Inspections– Headed for Full Implementation
Do you know? To rely on each other’s Good Manufacturing Practice (GMP) inspections pertaining to human medicines, the European Union (EU) and the United States (US) have signed a Mutual Recognition Agreement (MRA) in 1998. However, despite a series of actions and progressive discussions, it was never operational. But the talks which began in 2014 led to revision of Annex in 2017. As a result, on Nov 1, 2017, the agreement was brought into force that helped both the territories to recognize each other’s inspection expertise and resources.
Takeaways from FDA’s Final Labeling Rule for Using Symbols
A bridge between U.S. and Worldwide Labeling Requirements
The US Food and Drug Administration (FDA) has recently released the optional final labeling rule specific to use of stand-alone symbols in order to align to the global standards for medical device and in vitro diagnostic (IVD). This is the first time that the manufacturers in the U.S. will have the liberty to implement new labels to meet the labeling norms not only in the U.S. but also in the regions except U.S.