EU and US Mutual Recognition Pact Begins

02.11.2017 -

Following an agreement signed in August of this year, the EU and the US Food and Drug Administration (FDA) began mutually recognizing each other’s inspections of medicines manufacturing sites in their respective regions on Nov. 1.

The European Medicines Agency (EMA) described the move as “unprecedented,” saying the FDA has never before recognized another country’s inspectorate. The agency added that the pact enables both EU authorities and the FDA to make better use of their inspection resources and focus on sites of higher risk where APIs and medicines are being made for European or US markets.

“We need to think globally and work strategically with partners from around the world to make best use of our inspection capacity, so that patients can rely on the quality, safety and efficacy of all medicines, no matter where they have been manufactured,” explained Guido Rasi, the EMA’s executive director. “I am very pleased that we can now add the mutual recognition agreement with the FDA to our six existing agreements with third-country authorities.”

To date, the FDA has completed its assessments of eight EU member states, namely Austria, Croatia, France, Italy, Malta, Spain, Sweden and the UK.  The remaining states will be assessed on a rolling basis and be completed by Jul. 15, 2019.

The European Commission confirmed in June that the FDA had in place the capability, capacity and procedures to carry out good manufacturing practice (GMP) inspections at a level equivalent to the EU.

The mutual recognition initially covers medicines for human use with the exception of vaccines, plasma-derived medicines and investigational drugs, for example clinical trial material. According to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), veterinary products will be included not later than July 2019, while vaccines and plasma-derived medicinal products will be covered not later than July 2022.