Long awaited Commission’s proposal for a revision of the pharma package sees the light

The draft proposal is comprised by

• A Regulation replacing Regulation 726/2004 on the authorization of medicinal products and the establishment of the European Medicines Agency, and incorporates and amending Regulation 141/2000 on Orphan Medical Products and Regulation 1901/2006 on medicinal products for paediatric use.
• A Directive replacing Directive 2001/83 on medicinal products for human use and Regulation 1901/2006 on medicinal products for paediatric use.

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.