Less foreign inspection likely

FDA Consumer, Sept-Oct, 1997

Recent agreements may reduce dramatically the need for FDA inspection of regulated firms in European Union countries.

The United States and countries in the European Union have agreed that FDA and its EU counterparts may exchange inspection reports on pharmaceutical and medical device firms. In addition, the agencies may exchange medical device evaluation reports prepared by third parties, based on the existing FDA external review pilot program for selected devices. Appropriate confidentiality will be maintained, as well as public access to certain information.

Currently, FDA and the EU regulatory agencies conduct hundreds of such overseas inspections annually, at considerable expense to their taxpayers. Under the agreements when fully implemented, the agencies would each inspect the appropriate domestic firms and ensure compliance with the regulations of the country to which the firms export.

FDA's readiness to participate in such agreements is based on demonstrated equivalence of EU inspection procedures and good manufacturing practice standards. Equivalence would be assessed during a three-year transition period.

At all times, each agency retains full responsibility for products marketed in its own country and can take action necessary to protect the public health.