On June 26, 2019, Germany was included in the mutual recognition agreement between the European Union and the U.S. Food and Drug Administration (FDA). The FDA has thus confirmed the ability of this additional EU Member State to carry out inspections of good manufacturing practices (GMPs) at an equivalent level in the United States. The agreement recognises inspections of production sites for medicinal products for human use in different areas. The current scope of the agreement covers only medicines for human use, with the exception of vaccines and plasma products. Among the products covered by the agreement are: this also explains why recognition schemes are essentially similar, but that they vary in their practical implementation not only from one country to another, but also from one sector to another within a single country (e.g. telecommunications, CEMs, electrical security, medical equipment, food, equipment under pressure, etc.). These agreements benefit regulators by reducing dual controls in any other area, allowing for a greater focus on sites likely to be at higher risk and increased coverage of global supply chain inspections. The agreement is supported by strong evidence on both sides of the Atlantic that the EU and the US have a comparable regulatory and procedural framework for inspections of manufacturers of human medicines. Since May 2014, teams from the EC, relevant EU, EMA and FDA authorities have been reviewing and evaluating their respective surveillance systems and working closely together to reach the stages of the agreement. List of CACs designated under the MRA between the European Community and the United States ec.europa.eu/enterprise/policies/single-market-goods/international-aspects/mutual-recognition-agreement/usa/index_en.htm This illustrates the difference with respect to technical harmonization: while the development of an international standard takes years to finally be accepted and implemented by all parties involved, the aim of mutual recognition agreements is to create a working basis for mutual recognition of compliance assessment procedures using partner country rules before achieving them. Since 26 June, Germany has also been recognised.

Slovakia, which is expected to be recognised in mid-July 2019, is still expected. What happens next? The answer can be found in an EMA question-and-answer document, updated on 27 June 2019. It explains which countries have been recognized when, what has been in effect since November 1, 2017, which products are included or excluded, how the combined products are included and what will happen next. Full recognition of all EU Member States is expected by 15 July. This would be the precondition for an additional comprehensive review of a drug imported from the United States to no longer be required.