The updated Council text on the General Pharmaceutical Legislation marks an important step in the development of regulatory sandboxes in the EU. By setting out a mechanism for innovative medicinal products, it provides a more operational framework that is highly relevant to the BRIDGE project.
Since December 2025, the Final Agreement has advanced the new Pharmaceutical Regulation laying down European Union procedures for the authorisation and supervision of medicinal products for human use and established rules governing the European Regulatory framework and operations. The updated Council text, issued in February 2026 under Interinstitutional File 2023/0131 (COD), represents a major step forward as it sets out a concrete regulatory sandbox mechanism specifically for innovative medicinal products. It complements the earlier policy signals contained in the December 2025 EU Health Package, which BRIDGE examined in a previous news article.
When can a regulatory sandbox be established?
Chapter IX of the Council text sets out the key elements of this new framework. It defines the conditions under which a regulatory sandbox may be established, including cases where scientific or regulatory challenges make full compliance with existing requirements impossible, provided that the product shows a distinct potential contribution to quality, safety, efficacy, or patient access based on available scientific evidence.
The sandbox enables time-limited and targeted adaptations across the product lifecycle, including development, clinical trials, authorisation and market entry, under the direct supervision of Member State competent authorities and with immediate notification obligations where risks arise.
EMA’s role in the sandbox process
Within this framework, EMA plays a central role. It monitors emerging medicinal products, identifies candidates for sandboxing, and recommends to the Commission when a sandbox should be set up, after consulting with the relevant national authorities and other relevant bodies.
EMA also develops a detailed sandbox plan that justifies the need for adaptations, specifies their scope, proposes a timeline, and includes mitigation measures, as well as anti-distortion measures where appropriate. EMA charges a fee for these activities.
On this basis, the Commission formally establishes the sandbox through an implementing act that defines the final sandbox plan, its duration and expiry, and the participating products or actors. The system incorporates flexibility and safeguards by allowing the Commission to suspend, revoke, amend, or extend a sandbox if the conditions are no longer met or if risks emerge, while preserving a clear path back to standard regulation.
Flexibility with safeguards
The council text makes clear that products developed under a sandbox still require a standard marketing authorisation, with the initial validity of that authorisation limited to the duration of the sandbox. Any adaptations must remain strictly necessary, justified, specified and limited to those set out in the sandbox decision.
In addition, the summary of product characteristics and the package leaflet must indicate that the product was developed as part of a regulatory sandbox for the duration of that sandbox.
Participants remain fully liable under the Union and national law for any harm to third parties and must promptly notify EMA of any information that could affect the sandbox or raise quality, safety or efficacy concerns.
EMA, with input from Member States, will produce annual public reports on the functioning of regulatory sandboxes, including numbers, trends, good practices, challenges, lessons learned and recommendations, which the Commission may use to propose updates to the wider regulatory framework.
Why this development matters for BRIDGE
This development is particularly important for BRIDGE. The updated framework provides a level of operational detail that the project can directly address.
First, the pharma-specific mechanisms – from EMA’s monitoring and sandbox planning to Member State supervision and lifecycle adaptations – closely mirror the design elements that BRIDGE is developing through its MOSAIC architecture and case studies.
Second, the combination of EMA’s proactive monitoring and the annual sandbox reports establishes a structured learning and feedback loop into which BRIDGE’s horizon scanning, simulation work and good practices can be incorporated.
Third, the balance that the framework strikes between targeted flexibility and robust safeguards around safety, liability and oversight aligns well with BRIDGE’s emphasis on safe and legally robust experimentation in real-world settings.
Taken together, these developments confirm that BRIDGE is already highly relevant to the implementation of the new pharmaceutical legislation, even before the Council text is finally adopted and the sandbox provisions are fully operationalised.