The US FDA has completed the capability assessment for an additional 5 EU regulators in November 2018:
- Estonia (State Agency of Medicines / Ravimiamet)
- Belgium (Federal agency for medical and health products / Fedraal Agentschap voor geneesmiddelen en gezondheidsproducten/ Agence fédérale des médicaments et produits de santé)
- Denmark (Danish Medicines Agency / Laegemiddelstyrelsen)
- Finland (Finnish Medicines Agency / Lääkealan turvallisuus- ja kehittämiskeskus (FIMEA))
- Latvia (State Agency of Medicines / Zāļu valsts aģentūra)
FDA is collaborating with inspectorates it has assessed as capable and is reviewing their recent inspection reports and related information in determining each manufacturer’s suitability for the U.S. market in lieu of an FDA site inspection. However, FDA will continue to perform some inspections in EU countries with capable inspectorates, such as product manufacturing assessment inspections to support marketing approval decisions. However, FDA expects to perform fewer routine surveillance inspections in EU countries with a capable inspectorate.
The list of inspectorates FDA has assessed can be found on FDA’s website.
FDA has now completed assessments for 20 EU countries, and expects to complete its capability assessment of all EU inspectorates by July 2019.