EMA Official Details Obstacles to Reaching Mutual Reliance on GMP Inspections

European and U.S. regulators have made strides towards mutual recognition of quality inspections so that companies being inspected by one regulator would not have to face an inspection by the other, but setbacks still remain, a top European regulatory official said.

The FDA and Europe have been sharing inspection reports since 2003, and in the past few years have in some instances relied on each other’s inspections, Emer Cooke, head of international affairs for the European Medicines Agency, said.

“If we know that a site has already been inspected by a trusted regulator we can defer an inspection or deprioritize it,” she said.

Since January 2014, the European Medicines Agency (EMA) has received roughly 20 to 30 FDA inspection reports for U.S.-based pharmaceutical facilities, Cooke said.

However the two agencies haven’t yet established a formal mutual reliance agreement and some obstacles continue to hinder the current informal process.

For instance, the FDA redacts its inspection reports to remove any trade secrets per U.S. law, Cooke said. The redactions can make it difficult for European regulators to determine if they can rely on the report to forego inspections of the site, she explained.

Another hurdle is that EU and U.S. investigators may have different priorities. For example, the FDA could inspect a site that manufactures multiple products, and yet investigators may not focus on the two products that are marketed only in Europe, Cooke said.
 
The FDA and EU held a joint meeting at the end of March that included discussion on how to leverage each other’s inspection resources.

Earlier this week, the FDA announced an initiative to share more quality inspection data with European regulators. However, details on the new initiative remain sketchy, and the agency refused to comment further.

Reducing Redundant Inspections

The U.S. and European generic and brand pharmaceutical industries both want mutual recognition included in a new trade pact called the Transatlantic Trade and Investment Partnership (TTIP).

Mutual reliance would result in fewer redundant inspections from both EU and U.S. regulators, which can sap resources and money, said GPhA and the European Generic medicines Association in recent comments to U.S. and European negotiators.

Cooke said in some instances an FDA and EU inspection could occur right after one another. “It takes a lot to host multiple inspections,” she said.

PhRMA and the European Federation of Pharmaceutical Industries and Associations also pushed for mutual recognition in comments on TTIP issued in October 2012.

The two groups noted that a written agreement could facilitate the disclosure of trade secrets. The agreement would have to confirm that both sides could protect any confidential information from being leaked, the comments read.

A fifth round of trade negotiations is expected to start May 19, and no timeline has been set for finalizing TTIP.

If TTIP includes a mutual reliance agreement, the U.S. will join Australia, New Zealand, Canada, Japan, Switzerland and Israel, which already have pacts with the EU.

While the EU is working to ensure mutual reliance on U.S. inspections, it hasn’t moved as quickly to put in such agreements with India and China, major exporters of drugs and active ingredients.

A prerequisite for any mutual reliance agreement is equivalent good manufacturing practice standards, Cooke said.

“I would say that we are very interested in assuring that countries like China and India have equivalent standards to those of the EU,” she said. “What we are doing is building up cooperation with regulatory authorities there and sharing information.”

The FDA appears to be taking a similar stance. The agency recently added more investigators in both countries and reached a five-year accord with India to share quality inspection data.

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