GMP Inspections by FDA and All Countries in the EU to Equalize By 15 July 2019 
[Thursday, May 23, 2019]

Over the last few years, the FDA and EMA have been working together to confirm that regulators in all European Union member countries can carry out GMP inspections at levels equivalent to the FDA. The goal is to recognize each other’s GMP inspections and avoid duplication of audits. EMA recognized FDA to be an equivalent organization for GMP inspections on 1 November 2017. However, each EU member country needs to ratify EMA-FDA agreement and get recognized by the FDA as an equivalent country for GMP inspection standards. This week it was announced that all but 4 EU countries have been recognized to be equivalent to FDA, and that by 15 July 2019, all EU member countries will be confirmed to be equivalent to US with regards to GMP inspection standards. So, manufacturing sites successfully audited by EU countries will be acceptable to FDA and vice versa. However, it is not clear if this would apply to sites worldwide or only to the sites located in the EU and US. For example, it is not clear if sites located in the rest of the world that have been approved by EU auditors, avoid being audited by the FDA. Harmonization of GMP audits is highly desired as it is nearly impossible for one regulatory agency to inspect all GMP sites to a reasonable frequency. FDA and EMA are already struggling to meet their intended goals for GMP inspections. Over time, it should be expected that all manufacturing sites supplying products to EU and US would have at least one of the recognized inspectors audit them creating a reliable supply.