Protecting patient safety through a fit-for-purpose regulatory framework on nanomedicines

Question for written answer  E-002035/2021
to the Commission
Rule 138
Pietro Fiocchi (ECR)

Nanomedicine is an emerging, innovative field with the potential to address unmet medical needs, offering possible alternative treatments for diseases that are challenging to treat, such as cancer and cardiovascular diseases.

However, the lack of a centralised approval procedure for nanomedicines and their follow‑on products, nanosimilars, presents a potential risk for patient safety due to differing regulatory approval processes at national level. Due to the complexity of their manufacturing processes, where even the smallest change can result in different levels of efficacy and outcomes, it is vital that a centralised approval process is introduced covering nanomedicines and nanosimilars to protect patient safety.

In its pharmaceutical strategy for Europe, the Commission states that it will ensure patients in the EU have access to high‑quality, effective and safe medicines, and support the competitiveness and innovative capacity of the EU’s pharmaceutical sector.

In the light of the Commission’s commitment to protect patient safety and support innovative manufacturing, could it answer the following questions:

• 1.In its review of the overarching pharmaceutical regulatory framework, will the Commission ensure that nanomedicine is recognised as an innovative area of manufacturing requiring regulatory recognition?
• 2.To that end, will the Commission abide by its commitments on patient safety and introduce a fit‑for‑purpose, centralised approval process for nanomedicines?