Mutual Recognition Agreement Between FDA and EMA: What You Need to Know
The pharmaceutical industry is a global market, with products and suppliers spanning across borders. In order to ensure the safety and effectiveness of medicines, there needs to be a system in place whereby regulatory agencies can work together to share information and cross-check approval processes. This is where the Mutual Recognition Agreement (MRA) between the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) comes in.
The MRA between the FDA and EMA was signed in March 2017 and went into effect in November of the same year. The agreement aims to reduce regulatory burdens and avoid duplicative testing while maintaining the same level of safety and efficacy for medicines in both regions.
Under the MRA, the FDA and EMA are able to recognize each other`s inspections of manufacturing facilities and can rely on each other`s assessments of manufacturing practices, quality systems, and controls. This means that if a facility is inspected by one agency, the other agency will accept that inspection and vice versa.
This is a significant step towards enhancing global regulatory cooperation and reducing unnecessary costs for pharmaceutical companies. By avoiding duplicative inspections and assessments, companies can save time and resources, which can ultimately lead to lower prices for consumers.
The MRA also benefits patients, as it ensures that medicines approved by either agency meet the same high standards of safety, efficacy, and quality. This is particularly important for patients who rely on medicines that are not available in their own country, as it ensures that these medicines meet the same standards as those approved domestically.
However, it is important to note that the MRA only covers certain types of medicines. Specifically, it covers human drugs and biologics, excluding vaccines and plasma-derived products. Furthermore, the MRA does not cover medical devices or veterinary medicines.
Overall, the MRA between the FDA and EMA is a positive development for the pharmaceutical industry, patients, and regulatory agencies. By working together, the FDA and EMA can ensure that medicines meet the same high standards of safety, efficacy, and quality, while reducing regulatory burdens and costs for companies. As the pharmaceutical market continues to globalize, it is important to have systems in place that facilitate cooperation and communication between regulatory agencies, and the MRA is a significant step in that direction.