FDA and UK Expand Mutual Recognition Agreement
FDA and the United Kingdom are expanding their ongoing mutual recognition agreement (MRA) to include animal drug inspections. FDA says this will allow them to rely on each other’s inspection reports and related information, which will avoid duplication of some animal drug inspections and enable regulators to devote more resources to other areas that have greater risks.
“Over the past several months, the FDA has taken numerous steps to prepare for expanding and implementing the MRA’s coverage to include animal drugs,” an FDA notice says. “This has included, among other things, sharing information with the UK about FDA’s Center for Veterinary Medicine’s oversight of animal drug manufacturing in the U.S.; observing an audit performed by European Union auditors of an inspection that was conducted by a VMD [UK’s Veterinary Medicines Directorate] inspector; and conducting an evaluation of the UK’s regulatory framework, which found the UK has the capability, capacity and procedures to carry out routine GMP surveillance inspections that meet FDA requirements for animal drugs.”
On the human drugs side, FDA completed “capability assessments” of the 28 European Union (EU) member states under the FDA/EU MRA. The completed assessments allow FDA to rely on the drug inspections conducted by foreign regulatory authorities in: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Greece, Germany, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, and the United Kingdom.
“We see evidence that the MRA is creating important efficiencies,” the agency said at the time in an online post. “Before the MRA was implemented, the EU and the FDA sometimes would inspect the same facilities in the same year, even if the facility had a strong record of compliance. We expect the MRA will reduce this duplication, allowing the FDA and the EU to reallocate their resources towards inspection of drug manufacturing facilities that have potentially higher public health risks.”
Additionally, FDA said that information from EU inspection reports will help it with deciding which sites to inspect under the agency’s risk-based site selection model, “ensuring that our resources are allocated in the most efficient and appropriate manner, while considering risks in the product and manufacturing process that could cause potential harm to patients.”