By Johan Strömquist
Over the years NDA Group has had the privilege of contributing to an increasing number of drug development success stories. We supported over 45% of the new products approved in the EU in 2013, with strategic input at critical points in the development plan aligned with full submission support. We’ve also contributed significantly to over 64 different major regulatory submissions over the past five years.
Through our exposure to and long experience with a large number (500+) of different life science companies from all over the world at NDA we’ve identified a number of critical points that have a significant impact on the success rate of any drug development program aiming for Europe. This experience is particularly relevant for US drug development companies interested in approaching the EU.
The EU population comprises in excess of 500 million people compared to the US’ 318. Together, the EU countries form the second biggest market in terms of revenue for the pharmaceutical industry. In spite of the per capita health care expenditure in the US being significantly higher than that in the EU, the sheer number of treatable patients means that many products would double their revenue as soon as they’re introduced in the EU.
With a larger, and aging, population there will also naturally be more patients in need of good products. Most developing companies with a passion for improving the lives of patients will eventually have to take a global approach to product development and marketing. The first step for a US drug developer to go global is often spelt “EU”.
When the business opportunity and the patient need is so clear in Europe, the critical question is: How do you best ensure regulatory success to reach patients in the EU?
At NDA we’ve identified a large number of pit falls and challenges facing US based drug development companies as they start considering entering the EU market. These challenges vary between therapy areas, technology platforms and patient populations but some high level characteristics can be identified which are associated with companies who have successfully negotiated the complex EU framework, often with our support, and have planned and executed their program in order to be harmonised to meet both FDA and EMA requirements.