FDA Official Sees Progress in FDA-EMA Development of Mutual Reliance Initiative

To spur greater mutual inspection reliance between the FDA and EU, the agency and Congress are working to grant the EMA access to unredacted inspection reports.

Currently, the FDA has to redact trade secret information from inspection reports before giving them to European regulators. However, the EMA has no similar policy, said Helen Saccone, senior advisor of global regulatory policy with the FDA’s Office of Global Regulatory Operations and Policy.

The FDA also is in the process of developing an internal wish list of what it wants from a mutual reliance program, Saccone said during a mid-November session of the FDAnews Inspection Summit in Bethesda, Md.

The two agencies are auditing each other’s inspection processes and comparing conflicts of interest.

By the end of the year, the FDA is expected to have observed inspections in more than one-third of the 28 EU member states, including Germany, which is “like a mini EU with its own separate inspectorate,” Saccone said.

Mutual inspections in the EU are of increasing importance, as 43 percent of CDER’s foreign inspections between 2010 and 2014 occurred in the member states.

Specifically, six EU members — Germany, Italy, France, Spain, Ireland and the UK — represent the vast majority of drugs imported into the U.S. The top four — Germany, France, Ireland and the UK — imported more than $5 billion in drugs during fiscal 2014. As of fiscal 2014, there were more than 200 FDA registered facilities in Germany, in excess of 100 in the U.K., France and Italy and dozens in Spain and Ireland. — Kellen Owings

 

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