Pediatric Exclusivity Incentives Proposed In European Commission Draft Reg
This article was originally published in The Pink Sheet Daily
Executive Summary
The lack of information on pediatric use of drugs remains a problem in Europe, EC's Brunet tells DIA EuroMeeting in Prague. A draft proposal would create a new marketing authorization system and provide data exclusivity to incentivize pediatric studies in off-patent drugs.
|
A draft European Commission regulation would create a new "Pediatric Use Marketing Authorization" to encourage the study of off-patent drugs in children. "So far the specific research into the authorization of medicine for children in Europe is still a problem," European Commission Pharmaceutical Unit Head Philippe Brunet said at the DIA EuroMeeting in Prague March 10. "Our aim is to adopt a proposal in May in order to provide a new regulatory framework and to try to change the current situation," Brunet said. "This week we have launched a public consultation on our draft proposed regulation." The 1 proposal, issued March 8, would set up a system of requirements and incentives similar to the "pediatric rule" and pediatric exclusivity in the U.S. New and patent-protected products could gain an additional six months of market exclusivity for "the submission of data in children (whether positive or negative) and updating of the product information," the proposal says. For older products, "the draft EU pediatric regulation proposes to use the incentive of data protection on any new studies on the safety, quality and efficacy of the product in children linked to a new type of marketing authorization, the Pediatric Use Marketing Authorization (PUMA)." The typical period of data exclusivity in the EU is 10 years. Proposed legislation would guarantee 10 years and provide a one-year extension for a new indication. Under PUMA, a drug indicated for pediatric use would retain the same brand name but "shall include a superscript of the letter 'P' in blue lettering surrounded by the outline of a star, also in blue." The European Commission will accept comments on the regulation until April 9. - Catherine Harrison |