Home » FDA Approves Two More EU Member States Under GMP Inspection Agreement
FDA Approves Two More EU Member States Under GMP Inspection Agreement
Drugs Submissions and Approvals
The FDA confirmed that Lithuania and Ireland have the capability to carry out GMP inspections at a level equal to the U.S., the EMA announced Friday, marking further progress for the EU-U.S. mutual recognition agreement announced in March 2017.
The addition of the two countries marks a total of 14 EU member states whose inspection results can be relied upon by the FDA to replace its own inspections.
The EMA said plans are on track for the MRA to be operational in all member states by July 15, 2019.