Officials in the European Union (EU) and the United States (US) have decided to start assessments of manufacturing sites for human medicines directed in their particular areas on both sides of the Atlantic.
The contract will enable both the EU authorities and the FDA to make better use of their assessment funds to help them to concentrate on other parts of the world where active pharmaceutical ingredients (APIs) and medicines for the EU or US markets are manufactured. This will ensure that patients can rely on the quality, safety and efficacy of all medicines, no matter where they have been produced. 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.
Each year, national proficient authorities from the EU and the US Food and Drug Administration (FDA) inspect many production sites of medicinal products in the EU, the US and elsewhere in the world, to certify that these sites operate in compliance with good manufacturing practice (GMP). Under the new agreement, EU and US regulators will rely on each other’s assessments in their own areas. In future, the need for an EU authority to inspect a site located in the US, or vice versa, will be partial to remarkable conditions.
In the EU, inspections of manufacturing sites are carried out by national proficient authorities from EU Member States. The European Medicines Agency plays an important role in directing these activities in association with Member States.
The contract is reinforced by strong evidence on both sides of the Atlantic that the EU and the US have comparable regulatory and procedural frameworks for inspections of manufacturers of human medicines. Teams from the European Commission, EU national competent authorities, EMA and the US FDA have been auditing and evaluating the respective managerial systems since May 2014, and have worked closely together to reach this agreement.
The agreement is an extension to the EU-US MRA which was signed in 1998 but is not yet executed. Many provisions of the agreement have already entered into force and others will enter into force on November 1, 2017. By that date, the EU will have completed its valuation of the FDA and the FDA is likely to have accomplished its valuation of at least eight EU Member States, and will be progressively prolonged to all Member States.
Dated:2nd March 2017