FDA and EMA Clusters

The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) regularly collaborate on a number of regulatory topics in the form of "clusters". Meetings of the cluster take place by regular videoconference and the information exchange is covered by confidentiality agreements between the agencies. Such clusters have previously been established by the FDA and the EMA to discuss a variety of issues, such as biosimilars, medicinal cancer treatments, orphan drugs, paediatric medicines and blood products. Many of these clusters are not limited to the FDA and EMA. Agencies such as Health Canada, the Australian Therapeutic Goods Administration and the Japanese Pharmaceuticals and Medical Devices Agency are involved in several of these collaborations. The newest cluster on pharmacovigilance was announced in February 2014.

According to the EMA's Executive Director, Guido Rasi, "in an increasingly globalised pharmaceutical market, collaboration between medicines' regulators is essential. Medicines' regulators are inter-dependent: any action taken in one territory has repercussions on the rest of the world".1 The FDA and the EMA each cover a large population and a systematic exchange of information and expertise can assist in deciding the best course of action. In the context of pharmacovigilance, both agencies will often be dealing with complex drug safety issues at the same time as each other. The pharmacovigilance cluster also includes the Canadian and laptopJapanese regulatory agencies as observers. The framework of the cluster allows the agencies to develop a deeper understanding of each other's approach and actions in response to safety issues. Crucially, however, the formation of a cluster does not require the EMA and the FDA to arrive at identical regulatory decisions. Differences in health care systems and in agency practices may mean that different courses of action are adopted by different regulators. Overall, greater information sharing should improve the quality of information an agency has to consider in reaching its decision and lead to better outcomes for patient safety.

There is also a benefit to industry through increased collaboration between agencies. For example, the work of the biosimilars cluster has included plans for a common clinical data package that may address the approval requirements of both the EMA and FDA. If clusters can work to harmonize procedural requirements where possible, this will help streamline the industry's dealings with individual agencies.

In addition to the ongoing work of the clusters, the EMA and FDA hold bilateral meetings every 18 months, with the most recent meeting held in London in April 2014. These bilateral meetings allow the agencies to discuss established and proposed joint projects (such as the clusters) and orientate the scope of interactions between the two agencies. As the pharma industry becomes increasingly globalised, cooperation between international agencies will be valuable in tackling some of the industry's most challenging issues.

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Amanda Ebbutt

Amanda is a senior associate in the Intellectual Property department of our London office.