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International Collaboration / Pediatric Cluster

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The Office of Pediatric Therapeutics is engaged in international collaborative exchanges. The objective of these exchanges is to ensure that pediatric studies are conducted in a scientifically rigorous and ethical manner and that pediatric patients are not exposed to unnecessary (e.g., duplicative) trials. Pediatric legislation in the U.S. and Europe is driving pediatric product development on a global scale.

Pediatric Cluster

In August 2007, EMA and FDA established monthly teleconferences between regulators called the Pediatric Cluster to discuss product-specific pediatric development and topics related to product classes under the terms of Confidentiality Agreement. The objective of these exchanges are to enhance the science of pediatric trials and to avoid exposing children to unnecessary trials. This collaboration provides a robust ethical and scientific framework for pediatric studies. The teleconferences are held monthly but there may be additional meetings to accomodate timelines.

Japan's PMDA joined these teleconferences in November 2009 and Health Canada in September 2010 as observers. They are now active participants in these monthly exchanges. Australia's Therapeutic Goods Administration joined the teleconferences in January 2014 and they are now active participants in these exchanges.

The monthly discussions include ethical, safety, and pediatric study feasibility issues as well as protocol discussions. The type of information exchanged includes: Pediatric Investigation Plans (PIPs); Written Requests; Pediatric Committee (PDCO) discussions; waivers and deferrals; choice of comparator and efficacy endpoints; status of ongoing pediatric studies; results of pediatric studies; safety concerns, including clinical holds; and plans for long-term safety monitoring.

From August 2007 through March 2019, FDA and EMA exchanged information on a total of 517 products and held 172 discussions on general topics (not product specific).

In July 2018, we started a new process with our Pediatric Cluster teleconference. We share high level action items with the sponsor of products following discussion at the Pediatric Cluster.  The objective is to let sponsors know that their product was discussed and the agreed upon action.

Common Commentary

The Common Commentary is a tool to inform sponsors of products discussed at the Pediatric Cluster. The document provides informal, non-binding comments to sponsors on pediatric development plans that have been submitted to both FDA and EMA, which are under review by both agencies and have been discussed at the Pediatric Cluster. Please see additional information at the links at the bottom of page.

Common Commentary

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