Building an EFSA health claims dossier – The voice of experience

Compiling your final health dossier can sometimes feel like the “end game” and a job for the future but it is not something that should be left until all the research work and clinical trials are completed. In our experience at P2F Ventures the best data packages are compiled into a dossier over the course of several months and in the case of more complicated dossiers even longer. Under the existing regulations, applicants have an obligation to present the entirety of the scientific data relevant to their product and its particular health claim. This often includes non-proprietary data published in peer reviewed journals by other research groups. Identifying and organising such data requires structured searches, which takes time and it is definitely best done when you are not pressurised with writing up pivotal clinical trial reports. Developing a template submission early is a good tip for success.