Pediatric Research in Germany

1. EUs Pediatric Regulation Sees First Approval:

http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/...

2. Making Reality of Pediatric Rhetoric

http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/...

3. Pediatric Policies Grow Up

http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/...

Sufficient pediatric information on medicines used in children should be available; thus, pediatric clinical research should be enhanced. This is a consensus on a global basis and is now considered a public health priority. An increasing number of clinical trials are expected due to emerging laws and guidelines and governmental support and funding.1

Some background

PHOTOGRAPHY: GETTY IMAGES ILLUSTRATION: PAUL A. BELCI
Pharmaceutical companies are subject to market economy with assignment of limited resources to profitable products. Because the rules of market economy are not sufficient to create a demand in pediatric research, there is a need for societal intervention.2 The first effective measure addressing this issue was realized in 1997, when the Food and Drug Modernization Act (FDAMA) was adopted.

The measures of FDAMA encouraged companies to conduct studies of certain therapies being used in pediatrics by providing an exclusivity incentive provision.3 Further regulations followed including the Pediatric Research Equity Act, enabling the FDA to force companies to study certain drugs in children.4