22. EU-FDA Mutual Recognition Agreement
on GMP Inspections
Started in 1998
Partial
operation
Rapid alert system
Operational on 01
Nov 2017 In Operation Initially 8 EU member states
recognized by FDA
23. 8 EU Member States
Austria Croatia France Italy
Malta Spain Sweden UK
EU-FDA Mutual Recognition Agreement
on GMP Inspections
24. No duplication of inspections by the
respective authorities from 01 Nov 2017
Confidence building exercise done by both authorities to
assess the capability, capacity and procedures in place to
conduct GMP inspections
EU-FDA Mutual Recognition Agreement
on GMP Inspections