Regulatory Update: Mutual Recognition of Inspections by the EU and USA
The European Commission and US FDA have developed a Mutual Recognition Agreement (MRA) that recognizes the consistency of Good Manufacturing Practice (GMP) inspections between the two bodies. The agreement was reached in February 2017 and comes into effect on November 1, 2017. There will be a transition phase before full implementation in November 2019. The purpose of the agreement is to reduce duplication of effort and more effectively target inspection resources. It means that EU authorities will no longer inspect US-based facilities that are subject to FDA inspection, and the FDA will no longer inspect EU-based facilities inspected by the local regulatory authority.
In addition, under Article 9 of the agreement, the requirement under European Directive 2001/83/EC article 51 for any batch of drug product imported into Europe to be tested on European soil no longer applies to products manufactured at US-based GMP-licensed facilities. According to Article 19.3 of the MRA agreement, however, the provisions of Article 9 shall not apply until the date on which all the EU Member State authorities for human pharmaceuticals have been recognized by the FDA. The FDA will review each European member state’s pharmaceutical legislation, guidance documents and regulatory requirements individually during the transition phase between November 2017 and July 2019. Until this phase is complete, the requirement to perform QC testing for batch release in the EU for products manufactured in the United States is still applicable.
Companies that currently conduct testing at European- and US-based facilities will be able to consolidate their quality control activities to a single site. In order to do this, market authorizations detailing the testing facilities will need to be revised once the MRA is fully in force.
The agreement applies initially to human pharmaceutical products, intermediate or in-process products, and active pharmaceutical ingredients; it is expected to be extended to veterinary medicinal products, vaccines and blood-derived products in due course.