FDA Recognizes Polish, Slovenian Inspections
The FDA has agreed to recognize Polish and Slovenian GMP inspections, expanding the number of European countries with reciprocal inspection regimes to 22.
The U.S. and EU have set a July deadline to set up mutually recognized inspection in all EU states.
The latest agreement leaves Bulgaria, Luxembourg, The Netherlands, Cyprus, Slovakia and Germany outstanding.
Regulators on both sides of the Atlantic are optimistic they’ll meet the deadline, which they hope will allow them to direct more inspection resources elsewhere.