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Focus on Regulation

Tag Archives: NCA

Pharmaceutical Sector remains under Scrutiny of EU Competition Enforcers

Pharmaceutical Sector remains under Scrutiny of EU Competition Enforcers
On 28 January 2019, the European Commission published its Report to the Council and Parliament regarding “Competition enforcement in the pharmaceutical sector (2009-2017)” (“Report”). The Report summarizes the impressive enforcement activity of EU competition law enforcers in the pharmaceutical sector in the last decade while emphasizing at the same time the scope for continued enforcement action.

FDA Denies 5-Year Exclusivity to “Stable Esters” and Confirms Structure-Based Approach to Exclusivity

For sponsors developing new chemical structures based on previously approved active ingredients, two new FDA decisions offer a clear – though hardly satisfying – standard for determining whether a new structure will be awarded 5-year “new chemical entity” (NCE) exclusivity.  In two letter decisions issued on the same day, the agency firmly explained that NCE