International Collaborations

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.

 

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Distribution of Pediatric Patients in Studies Submitted to FDA (2002-2007), by Country

Data Source:
Globalization Facilitates Pediatric Drug Development in the 21st Century. Drug Information Journal, 2010   

EMA/Japan/Canada

In August 2007, EMA and FDA has established monthly teleconferences to discuss product-specific pediatric development and topics related to product classes to enhance the science of pediatric product development, and avoid exposing children to unnecessary trials. Principles of interactions between FDA and EMA are those of ICH E-11, European Union (EU) pediatric legislation (2007), and U.S legislations including FDAMA Pediatric Exclusivity (1997), Best Pharmaceutical for Children Act (2002),  Pediatric Research Equity Act (2003), and Food & Drug Administration Amendments Act (FDAAA) in 2007.

Japan’s PMDA joined these teleconferences in November 2009 and Health Canada in September 2010.

The monthly discussions include ethical, safety, and pediatric study feasibility issues as well as protocol discussions.Type of information exchanged includes: Pediatric Investigation Plan (PIP); written requests; Pediatric Committee (PDCO) summary reports; waivers and deferrals; choice of comparator and efficacy endpoints; status of ongoing pediatric studies; results of pediatric studies; safety concerns, including clinical hold; and plans for long-term safety monitoring.

FDA and EMA exchanged information on a total of 284 products and held 45 discussions on general topics (not product specific) between August 2007 and October 2012. The collaboration provides a robust ethical and scientific framework for pediatric studies.
 

Latin America

The purpose of FDA’s new pediatric Latin America program is to build, under our Confidentiality Commitment process, an ongoing mutually beneficial and constructive collaborative exchange of scientific information with regulators pertaining to pediatric clinical trials and product development. By exchanging ideas in a collaborative manner, we anticipate the development of a consortium of Latin American regulators given the increasing role of Latin America in pediatric therapeutic investigations.

Latin America is a major and growing geographical region for the conduct of pediatric pharmaceutical and medical device clinical trials. In 2011, OPT expanded their international program to include collaboration with regulatory agencies in Latin America. This new initiative has begun, in part, due to FDA’s ongoing successful exchanges with colleagues in Europe, as well as Latin America’s increasing role in pediatric medical product development outside of the United States. FDA receives data generated from pediatric clinical trials conducted in Latin America. Findings concerning the studies are documented in the following two publications authored by FDA’s Office of Pediatric Therapeutics.

The Globalization of Pediatric Trials: Should We Be Worried? Pediatrics 2011

Globalization Facilitates Pediatric Drug Development in the 21st Century. Drug Information Journal, 2010