FDA, EC in Pact for Pharma Manufacturing Facility Inspections

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 03-02-2017 17:18


The US Food and Drug Administration and the European Commission (EC) have adopted an agreement whereby US and European Union (EU) regulators will be able to use each other’s good manufacturing practice inspections of pharmaceutical manufacturing facilities in an effort to eliminate duplication of drug inspections, lower inspection costs, and enable regulators to devote more resources to other parts of the world that may be greater risk, according to the FDA.

The agreement, which amends the Pharmaceutical Annex to the 1998 US-EU Mutual Recognition, is the culmination of nearly three years of FDA and EU cooperation as part of the Mutual Reliance Initiative that now allows FDA and EU drug inspectors to rely upon information from drug inspections conducted within each other’s borders.

The agreement will not affect the process of approving medicines as it focuses only on inspections of manufacturing sites. The enhanced cooperation with US regulatory authorities will improve the EU's ability to identify and address problems at factories before they become a public health risk. It will also reduce the administrative burdens and costs facing pharmaceutical manufacturers, including smaller producers, according to the EC.

In 2012, Congress passed the Food and Drug Administration Safety and Innovation Act, which gave the FDA authority to enter into agreements to recognize drug inspections conducted by foreign regulatory authorities if the FDA determined those authorities are capable of conducting inspections that met US requirements. Since May 2014, the FDA and the EU have been collaborating to evaluate the way they each inspect drug manufacturers and assessing the risk and benefits of mutual recognition of drug inspections.

The FDA was invited to observe the EU’s Joint Audit Program, in which two EU nations audit the inspectorate–the regulatory authority–of another EU country. The FDA first observed the audit of Sweden’s inspectorate by auditors from the UK and Norway. Since then, the FDA has observed 13 additional audits of drug inspectorates across the EU with more audit observations planned through 2017.

The agreement is the result of cooperation between the EC, the European Medicines Agency, and the FDA. The recognition of inspections can apply as early as November of this year, according to the EC.

Source: Food and Drug Administration and European Commission 


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