Pharmaceutical Manufacturing in the EU and the EU-US Mutual Recognition Agreement.

Abstract

The pharmaceutical industry is one of the most competitive sectors in Europe and has a strong presence in many European Union (EU) countries. The mutual recognition agreement (MRA) for inspections of medicines manufacturers between the United States (US) Food and Drug Administration (FDA) and the EU started by the end of 2017 and gradually extended to all EU member states (MSs) in July 2019. We quantified the number of FDA and EU good manufacturing practice (GMP) inspections carried out in each other's territory between 2009 and 2018. The five EU MSs with the largest number of FDA inspections were Germany, followed by Italy, France, the United Kingdom (UK), and Spain. All of them, with the exception of Germany, were included in the group of the first eight EU MSs recognized by the FDA in the context of the MRA. In 2018, these five EU MSs were within the top 10 EU exporters of pharmaceutical products to the US. Four of these five EU MSs (Italy, Germany, France, and the UK) accounted for 53.4% of the total pharmaceutical production in the EU in 2018. We also studied the type of manufacturing operations covered by the manufacturer's authorizations issued by each EU MS for the manufacturers within its territory. We verified a high prevalence of conventional technology versus complex technology manufacturing for many EU countries. Going forward, this unbalance should be addressed at a national and EU level. Supporting for instance (bio)pharmaceutical manufacturing through pharma policy initiatives, especially for EU countries with a lower level of innovation and technological development, would promote the pharmaceutical manufacturing sustainability and competitiveness of these countries. The full implementation of the MRA between the US FDA and the EU can make it faster and less costly for both sides to bring medicines to the market, improving future competitiveness of the EU and the US pharmaceutical industry.