The new EU regulation to be implemented in 2016 is supposedly bringing several advantages for sponsors overall, mostly related to money and time savings. However, Karim Bagaté, Clinical Pharmacology Research Manager at Skye Pharma in Switzerland questions some of the new points introduced.
CTA: What are the key advantages of the new EU regulation?
KB: The new regulation states that there will be one single application dossier and one central point for submission of all documents to all competent authorities. For example, currently as a regulatory manager you would need to do 20 submissions in 20 different countries. With the new regulation you will only need one submission. In this way you save time and money.
Another advantage is that, in the past, the submission was paper-based whereas now it will be electronic for all countries. This will make processes easier and faster because you will not need to submit the same dossier 20 times.
Also, these changes will impact CROs and this might be an advantage for sponsors because we will pay less money to the CROs to submit the documents. CROs will spend less time on submissions, which means less revenue for them. Perhaps CROs will come up with a different strategy; maybe they will sell the clinical trial submissions as a package.
CTA: Do you consider the new EU regulation to be positive overall?
KB: As a sponsor yes, because one of the goals of this regulation is the harmonization that we have been looking for so that we do not have to submit different documents to different countries. It makes our life easier. However, there is one point that is going to be controversial and that is transparency. The regulation says that everything has to be disclosed on the database. This might be a problem if we have to disclose everything as it is written in the regulation as we do not want to disclose our company’s IP.
CTA: How are you adapting to the new regulation?
KB: We are attending conferences about the topic. I also read and try to understand what is behind it. We need support from the CROs. The CROs do the submission on our behalf and they need to be able to understand the new regulation in order to do so. They have to be ready for the new regulation.
CTA: Is there anything that could still be improved?
KB: It is difficult to say right now as everything is virtual. I do not know how the Directive will operate once it is applied. But the revision time could be shorter as in some countries the time is now shorter than what the regulation is suggesting.