Updated: US-EU Agreement on GMP Inspections Adds 5 More Member States
The US Food and Drug Administration (FDA) earlier this month confirmed the capabilities of Belgium, Denmark, Finland, Estonia and Latvia so that FDA can now rely on the inspections in each of those countries, reducing the need for duplicative work.A total of 19 member states in the EU are now qualified by FDA as having the capability, capacity and procedures in place to carry out good manufacturing practice (GMP) inspections at a level equivalent to the US. However, the European Medicines Agency (EMA) notes that imported products still need to be batch tested until FDA recognizes all member states' authorities for human pharmaceuticals, which is expected to be completed no later than 15 July 2019.
"Plans for the agreement to be operational in all EU Member States by 15 July 2019 are on track," the European Commission said Thursday.
An expansion of the agreement to cover veterinary medicines will be assessed by 15 July 2019 and vaccines for human use and plasma-derived medicines by 15 July 2022.
Background
In March 2017, the landmark agreement between the US and EU to mutually recognize drug manufacturing inspections was formed. And in June 2017, the European Commission confirmed that FDA has the capability, capacity and procedures in place to carry out GMP inspections at a level equivalent to the EU.
Since 1 November 2017, EU member states can rely on inspections from FDA to replace their inspections.
“Around 40% of finished medicines marketed in the EU come from overseas and, for around 85% of medicines sold in the EU, at least one manufacturing step takes place outside the Union,” EMA said.
Since then, FDA has been confirming the capabilities of regulators in EU member states. The first eight were added in October 2017 and include Austria, Croatia, France, Italy, Malta, Spain, Sweden and UK. Then in March, Czech Republic, Greece, Hungary and Romania were added, while in June, Ireland and Lithuania were added, and Portugal was added in September.
EMA also has mutual recognition agreements with Australia, Canada, Israel, Japan, New Zealand and Switzerland.
EMA Mutual Recognition Agreements
Article updated on 11/29/18 to add Estonia to the list of countries.