Work in Parliament EU Pharmaceutical Strategy – specific provisions about nanomedicines and nanosimilars

Questions to the Commission and the Council | 20-05-2020

Question for written answer E-XXXXX/2020 to the Commission
Rule 138
Maria da Graça Carvalho, José Manuel Fernandes, Álvaro Amaro

Nanomedicines and their unique properties open up new and improved therapeutic opportunities. There is currently no specific regulatory framework designed for nanomedicines and their follow-on products, nanosimilars. At the moment, they 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.

Some years ago, the European Group on Ethics in Science and New Technologies outlined the importance of a dedicated robust safety framework on nanomedicines. Since then, the complexity and number of this new class of medicines have increased at a rapid pace and so have the questions assessing their quality, biological properties and therapeutic profiles.

A mandatory centralised procedure would in principle ensure better coordination and understanding across Europe, harmonise marketing procedures and ensure patient safety and awareness.

In light of the Commission’s intention to adopt a new framework for pharmaceuticals,

  • does the Commission intend to include specific references to nanomedicines in the EU Pharmaceutical Strategy?
  • Is the Commission proposing to address the authorization procedure of these products?
  • Would the plans of the Commission include the proposal of a centralised approval mechanism for nanomedicines and nanosimilars?
Please note, your browser is out of date.
For a good browsing experience we recommend using the latest version of Chrome, Firefox, Safari, Opera or Internet Explorer.