Portuguese MEP Maria da Graça Carvalho (PSD, EPP) questioned the European Commission about the absence of a specific regulatory framework for nanomedicine and products generated from this technology, the nanosimilars.
In a written question addressed to the executive led by Ursula von der Leyen, it is recalled that, “at the moment, these [techniques and products] can be approved through decentralized national procedures that risk creating uncertainties, confusion and ambiguity, seen the different interpretations and the different policies in place in each EU country”.
Recognizing the “unique properties” of nanomedicine, which “open new therapeutic opportunities”, but reinforcing the need to improve regulation for the reasons described, Maria da Graça Carvalho questions the Commission about its intentions.
More specifically, she asks whether the Commission intends to include specific references to nanomedicines in the EU Pharmaceutical Strategy, whether it intends to consider adoption procedures for these products, and whether it intends to create a centralized approval system.