Regulatory & Market Access

Our highly qualified regulatory team has achieved outstanding success in recent years, securing an unprecedented series of product approvals from the major authorities. With 14 major product approvals since 20141, including four new medical entities, their expertise is an essential component of Boehringer Ingelheim’s recent achievements.

Regulatory and Market Access
Working side-by-side with our R&D, Marketing and Regulatory teams, our market access team and corporate and local market access structures and processes have helped to achieve and sustain access and reimbursement of our products in most markets.

Recent achievements include:

Four Breakthrough Therapy designations2

Three orphan drug designations3

 

1 Approved by the US Food and Drug Administration and/or the European Medicines Agency
2 Since the inception of the classification in 2012
3 Granted by either the US Food and Drug Administration (FDA) and/or the European Commission (EC) since September 2016