What will 2014 hold for pharma?

Clinical trial regulations

Clinical trials have been a buzz word in pharma this year and it looks like it’s a trend which will continue into 2014. Debate has been caused by the future EU legislation on clinical trial regulations, governing the amount of data companies are required to publish. Some argue that a simplified regulatory framework for clinical trials will streamline the approvals process for Europe. This is hoped to speed up access to new medicines for patients and make Europe an attractive location for R&D. However, others think increased ‘transparency’ will discourage pharma companies from conducting trials in Europe, as well as raising concerns over patients’ personal data. Discussions at the end of December meant that a compromise has been reached on the initial text of the legislation which could be adopted in 2014. It could come into force two years after it has been adopted, so all eyes will be on Europe at the start of the year.

Personalized medicine