What is the European Medicines Agency (EMA)?

The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU), established in 1995, with its headquarters in Amsterdam, the Netherlands. Its primary role is to protect and promote public and animal health by evaluating and supervising medicines for human and veterinary use within the EU. The EMA is crucial in ensuring that all medicines available on the EU market are safe, effective, and of high quality.

The importance of the EMA stems from its central role in the EU's what-is-the-european-medicines-agencyregulatory system for medicines, which is among the most advanced and comprehensive in the world. By harmonizing the evaluation and supervision of medicines across the EU, the EMA ensures that all EU citizens have access to medicines that meet the same high standards of quality, safety, and efficacy. This harmonization also facilitates the free movement of medicines within the single market, significantly benefiting the pharmaceutical industry and healthcare systems.

What is EMA’s role in ensuring access to high quality and safe medicines?

Scientific Evaluation of Medicines: The EMA's core function is the scientific evaluation of applications for marketing authorization of medicines in the EU. This evaluation is carried out by the EMA's Committee for Medicinal Products for Human Use (CHMP) for human medicines and the Committee for Medicinal Products for Veterinary Use (CVMP) for veterinary medicines. These committees assess the quality, safety, and efficacy of medicines before they can be authorized for use in the EU.

Monitoring of Safety: The EMA plays a critical role in monitoring the safety of medicines throughout their lifecycle on the EU market. Through its pharmacovigilance activities and the Pharmacovigilance Risk Assessment Committee (PRAC), the EMA evaluates new safety information and can take action to protect public health, such as updating the product information, restricting the use of a medicine, or, in rare cases, withdrawing a medicine from the market.

Facilitating Access to Medicines: The EMA facilitates access to innovative medicines through various mechanisms, including the accelerated assessment procedure, which can reduce the time to evaluate medicines of major public health interest. The Agency also provides scientific advice to pharmaceutical companies to help them prepare more robust marketing authorization applications.

Promotion of Public Health: Beyond the evaluation and monitoring of medicines, the EMA engages in activities aimed at promoting public health. This includes the coordination of European and international efforts to combat antimicrobial resistance, the promotion of the rational use of medicines, and the support of research and development in the pharmaceutical sector.

International Cooperation: The EMA works closely with regulatory authorities around the world to harmonize regulatory standards and practices, facilitating global access to safe and effective medicines. This cooperation extends to sharing scientific expertise and contributing to global health initiatives.