Recently, the US and EU have come together to update a mutual agreement that pertains to the inspections of drug manufacturing. According to the European Medicines Agency, “[t]eams from the European Commission, EU national competent authorities, EMA and the US FDA have been auditing and assessing the respective supervisory systems since May 2014, and have worked closely together to reach this agreement.” Approximately 40% of medicines in the EU come from overseas and 80% of the manufacturers of APIs for medicines available in the EU are located outside the Union, so the ability to have a mutual agreement increases productivity for manufactures, while also ensure patient safety.
— EU in the US (@EUintheUS) March 2, 2017
This mutual agreement has a slew of positive attributes:
- Mitigates risk by improving the identification of potential problems at manufacturing sites in order to properly address them before it escalates into a public health risk
- Increases productivity and reduces duplication by better utilizing inspection capacity
- Allows for better use of inspection resources in order to focus on operational efficiency
- Improves consistency for EU & US sites, allowing for manufactures to comply to GMP & other compatibility with regulatory inspections
- Ensures safety for patients because of the assurance of quality, safety and efficacy
- Reduces administrative burdens and costs that impact pharma manufactures
Whether you are looking at it from a patient or manufacture standpoint, the value comes to both parties. As mentioned on the Delegation of the European Union to the United States website, “[t]he European Commission and the United States Food and Drug Administration have adopted an agreement to mutually recognise inspections of premises where medicines are produced. With this update of the 1998 Agreement on good manufacturing practices, EU and US regulatory authorities will be able to rely on each other’s information as regards facilities in the EU or US that manufacture medicines and active pharmaceutical ingredients for the European and American markets. The agreement will not affect the process of approving medicines, as it focuses only on inspections of manufacturing sites.” The inspections are projected to be applied in November 2017, so stay tuned for more updates on the progress.