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Given the speed of developments in the pharmaceutical sector it is perhaps no surprise that legal frameworks struggle to keep apace. In fact, nowadays, researchers produce more and more drugs that cannot be easily categorised according to the existing legal statuses. This is particularly true for a very promising cell supernatant, which is difficult to fit into existing categories. This article illustrates the difficulties related to the classification of such a supernatant and proposes necessary changes to the current EU legal statuses of medicinal products.

The Diversity of Drug Statutes Regarding Scientific Advances: How to Categorise a Culture Supernatant for Health Security Reasons