FDA Follows Through on its Promise to Recognize European GMP Audits

In early September, FDA and EMA announced that they will start recognizing each other’s GMP audits and starting Nov 1 FDA announced that it has started this with eight European countries. As of 1 Nov 2017, if a manufacturing site passed an audit by regulators from Austria, Croatia, France, Italy, Malta, Spain, Sweden and the United Kingdom; it will likely not need another audit from FDA. Similarly, audit findings from any of these regulators will be shared with FDA who in turn will expect the manufacturer to address all those findings prior to acceptance by FDA. By July 2019, FDA expects to recognize audits by all 28 members of the European Union. As noted earlier, this process does not just apply to sites located in Europe but audits conducted by European auditors in any country will be similarly acceptable to FDA. In the past, FDA and EMA had been at odds in terms of GMP compliance with sites being passed by one regulator getting dinged by the other. Manufacturers had also complained about diverse practices of the regulatory audits by different agencies. By harmonizing audits, FDA and EMA addressed several complaints and increase efficiency. It is important to note that these harmonization applies to all drugs, a few biologics and does not apply to medical devices. In effect the decision covers bulk of the products regulated similarly by FDA and EMA but leaves out the products where the two Agencies differ in compliance requirements. A key product category is that of cellular and gene therapies, and human blood and plasma products where the two agencies differ greatly in compliance and will continue to conduct their own audits. Medical devices similarly are regulated very differently in the two regions so harmonization for those products is not feasible. But except for the selected few product categories, most manufacturers should laud the launch of this new phase of regulatory harmonization.