News Feature | February 25, 2014

The FDA And European Medicines Agency Agree To Pharmacovigilance Cooperation

Source: Pharmaceutical Online

By Cyndi Root

The Food and Drug Administration (FDA) announced via press release that the federal agency and the European Medicines Agency (EMA) have agreed to cooperate on pharmacovigilance. The agencies are calling the new medicine safety meetings “clusters,” regular conferences on specific topic areas. These clusters will be predetermined areas necessitating intense focus by both agencies and other regulatory bodies. The recently created EMA’s Pharmacovigilance Risk Assessment Committee and the FDA plan to collaborate via videoconferences on a monthly basis.

Previous clusters have discussed cancer medications, generic drugs, orphan drugs, pediatric medications, and biological products. Agencies from countries like Japan and Canada have previously been involved in some clusters and will participate in the future. Janet Woodcock, M.D., Director of the FDA’s Center for Drug Evaluation and Research said, “The work of protecting the health and safety of the American people cannot be done in isolation. It is part of a larger collaborative global effort between the FDA and its international regulatory partners to ensure the health and safety of all our citizens.”

The European Medicines Agency

The European Medicines Agency (EMA) began in 1995. It is located in London and represents the European Union (EU). The EU is formally and informally structured. It wields political and economic power by binding together 28 nations. The EMA is a decentralized agency, meaning that it assists EU centralized agencies to design and implement policies. It carries out scientific and managerial tasks and cooperates with EU and foreign agencies. EMA’s Executive Director Guido Rasi said, “In an increasingly globalized pharmaceutical market, collaboration between medicines’ regulators is essential. International cooperation is a key area of work for the agency.”

Canadian Agency for Drugs and Technologies in Health

The Canadian Agency for Drugs and Technologies in Health (CADTH) is the regulatory health agency in Canada. It is funded by territorial, provincial, and federal agencies. The agency makes decisions on drugs, biologics, and devices. It provides information to the public, policy makers, and scientists so they can make informed decisions. 

Pharmaceuticals and Medical Devices Agency

The Pharmaceuticals and Medical Devices Agency (PMDA) is the regulatory body in Japan that regulates drugs. It works with the Japanese Ministry of Health, Labor, and Welfare. It functions like the FDA to protect the public safety by regulating pharmaceuticals.