European Regulatory Bodies and the Recall Process

By Mike Rozembajgier

Despite similarities between the U.S. Food and Drug Administration and the European Medicines Agency (EMA), the EMA’s role in Europe’s product recall process differs from that of the FDA in food, medical device, and pharmaceutical recall management. EMA’s involvement in recalls is unique even when compared with other European regulators. Although the EMA is involved in the evaluation of hundreds of medicines sold in Europe, there are thousands more drugs that do not come under its jurisdiction that are subject instead to the oversight of individual EU member states and mutual recognition agreements.

The EMA is considered the hub of an integrated European medicines network and is charged with ensuring the safety of drug development and manufacturing across the continent. Much like those of its American counterpart, the EMA’s responsibilities the scientific evaluation and supervision of pharmaceuticals for both human and animal use. As part of this responsibility, the EMA can suggest a pharmaceutical recall should it feel one is required. But it can only recommend or endorse a recall decision. It cannot order a recall outright.

The EMA is primarily concerned with medicines for which there is no clear consensus concerning authorization and use, stepping in to resolve disagreements. This is a significant consideration for international pharmaceutical developers who need to be sure that their safety standards meet those of individual European countries as well as European Union regulators which provide guidance on when and why a recall should be undertaken.

Recently, the EMA backed a precautionary recall of a pharmaceutical product used to prevent organ rejection in transplant patients, citing the presence of unusually large amounts of active pharmaceutical ingredients. As a result, pharmacies and wholesalers across the European Union are removing the shelves from pharmacy shelves.

But at roughly the same time, the EMA decided not to recommend the recall of a diabetes drug linked to an increased risk of bladder cancer. Instead, the regulatory body recommended that the drug only be used when other drugs have failed. In a news release announcing the decision, the EMA noted that there still exists a positive risk-benefit balance, and that it “remains a valid treatment option for certain patients…only when certain other treatments…have not been suitable.” The U.S. has taken the same position. But in June France decided to recall the drug.

It is important to note the EMA’s decentralized regulatory authority compared with that of the FDA. EMA plays a largely advisory role with a matrix of regulatory agencies with oversight in various countries and different products. As the European Union continues to refine its internal regulatory structures, international pharmaceutical developers and distributors should keep close tabs on the evolving roles of the various European regulatory bodies, paying particular attention to degree of influence each has. This will help the pharmaceutical industry better target potential recall management issues.

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