On 26 April 2023 the European Commission released the EU’s general pharmaceutical legislation.
The draft proposal is comprised by
It is important for the in silico medicine community that among the main objectives of the revision are supporting innovation, including in areas of unmet therapeutic need, adapting to scientific and technological developments and reducing excessive regulatory burdens. In this context, the proposal includes the introduction of regulatory ‘sandboxes’ that will allow testing new regulatory approaches for novel therapies under real world conditions. Most excitingly, in silico tools are mentioned in the package, specifically with respect to alternatives to animal testing.
In the Parliament the Regulation has been assigned to the S&D, while the EPP will be leading the development of the EP’s position on the Directive. As EU 2024 elections draw near, MEPs seem to maintain a certain level of optimism regarding the possibility of negotiating the file by the end of the current mandate. However, if no agreement is reached by early 2024, the case will then be passed on to the new legislature which will have to resume negotiations from the beginning.