EU and US Extend Mutual Recognition

06.03.2018 -

The EU and the US Food and Drug Administration (FDA) have extended their agreement on recognizing each other’s medicines inspections to include Greece, Hungary, Czech Republic and Romania with effect from Mar. 1.

The move follows the mutual recognition that began on Nov. 1, 2017 between the US and eight other EU countries, namely Austria, Croatia, France, Italy, Malta, Spain, Sweden and the UK.

Capability assessments in the 12 member states have been completed by the FDA, which said it officially recognizes the countries as “capable of carrying out good manufacturing practice (GMP).” The agency will assess the remaining member states on a rolling basis, to be completed by Jul. 15, 2019. The European Commission confirmed last year that the FDA has the capability and procedures in place to carry out GMP inspections at a level equivalent to the EU.

Both the EU and FDA said mutual benefits from the agreement include the ability to focus inspection resources on other parts of the world where APIs and medicines for EU and US markets are manufactured, as well as prioritizing inspections for higher risk cases. Other benefits would include reassuring patients of the quality, safety and efficacy of all drugs no matter where they are manufactured, improving the ability to identify and address problems before they become a health risk and reducing the administrative burden and costs facing drugmakers.