The United States and the European Union have agreed to recognize each other’s drug inspections. This mutual recognition is based on the legal framework of their Mutual Recognition Agreement of 1998. More specifically, the Parties have amended the Pharmaceutical Annex to the Agreement. This amendment was adopted on 1 March 2017 (hereinafter “the agreement”). The mutual recognition was signed by the Obama administration in January 2017 and by the European Commissioner for Trade, Cecilia Malmstrom, on 1 March 2017.
According to the European Medicines Agency (“EMA”), around 40% of finished medicines marketed in the EU come from overseas and 80% of the manufacturers of APIs for medicines available in the EU are located outside the Union. The agreement is thus an important step in transatlantic cooperation, given that the Transatlantic Trade and Investment Partnership (“TTIP”) between the US and the EU has been put on hold yet again without any promising progress in sight.
In the US as well as in the EU, competent authorities conduct inspections relating to the production of medicinal products. They verify whether the Good Manufacturer Practices (“GMP”) are complied with. In the European Union, the competent bodies of the Member States carry out the drug inspections coordinated by the EMA. In the US, the Federal Drug Administration (“FDA”) is responsible for examining manufacturers’ compliance with the GMP.
Since May 2014, the European Commission, the national competent authorities, the EMA and the FDA have been collaborating with each other to form the agreement by assessing each other’s supervisory systems. In a press release, the EMA explained that the agreement confirms that the EU and the US have comparable regulatory and procedural frameworks for inspections of manufacturers of human medicines.1
The agreement applies to pharmaceutical inspections of manufacturing facilities in the territory of the US or the EU before products are marketed (“pre-approval inspections”), as well as during the marketing of products (“post-approval inspections”), and to pharmaceutical inspections of manufacturing facilities outside the territory of either Party. As confirmed by the European Commission, the agreement will not have an impact on the placing on the market of medicines, but only concerns inspections of manufacturing sites.2
The agreement means that the US no longer has to inspect medicinal products manufactured in the European Union that have been subjected to local inspection and vice versa. Only in exceptional circumstances, both authorities will be allowed to carry out inspections on each other’s sites. Furthermore, EU and US authorities are still allowed to request the other authority to conduct a pre-approval or post-approval inspection of a manufacturing facility. If the recognized authority declines such inspection, the requesting authority is still allowed to conduct its own inspection of the manufacturing facility and the requested authority has the right to join the inspection.
The mutual recognition is important since it will enable the US and the EU to leverage and to reallocate their inspection resources, including by avoiding duplication of inspections, to improve oversight of manufacturing facilities and better address quality risk and prevent adverse health consequences.3 Furthermore, this mutual recognition will significantly reduce the administrative burden and costs for the pharmaceutical companies.
Many of the provisions have already entered into force and others will enter into force on 1 November 2017. The recognition of inspections will apply from November 2017 at the earliest.4