EU Reaches Landmark on Reform of Pharmaceutical Legislation

Conclusion of the trilogue on the so-called EU Pharmaceutical Package: In a major milestone, EU co-legislators have reached a provisional agreement to modernise the pharmaceutical framework for the first time in two decades. The reform package aims to make medicines more available, affordable, and innovative, while strengthening Europe's competitiveness and security of supply in a fast-changing global landscape.

While a provisional agreement has been reached, an exact implementation date is not specified. However, based on standard EU legislative procedures the next steps typically include a formal adoption by the Council and the European Parliament, followed by the publication in the Official Journal of the EU. The new legislation could be implemented within 12 to 24 months from the date of this provisional agreement. This timing allows for the necessary formal approvals, publication, and a transition period for stakeholders to adapt.

The deal will introduce both a new directive and regulation and represents more than a regulatory overhaul. It also influences GMP operations, inspections, compliance strategies, and lifecycle management. Here are some possible implications:

• GMP systems supporting accelerated pathways must demonstrate robust process validation, data integrity, and cross-site comparability. Regulators must expect more GMP-relevant activities before the originator's exclusivity expires.
• Quality systems must ensure anti-counterfeiting controls, especially when similarity to marketed products increases legal sensitivity.
• With less administrative burden in some areas, but continued GMP oversight across the product, lifecycle management becomes even more essential. Faster review times mean manufacturers must be "GMP inspection ready" earlier.
• Increased digitisation of dossiers requires further digitisation of GMP systems (structured data, digital batch records, harmonised variation documentation).
• The concept of "regulatory sandboxes" allows innovative technologies (e.g., decentralised manufacturing, AI-driven QC release, continuous manufacturing, personalised ATMP production) to operate under controlled conditions. That means that innovative therapies may be developed and tested under close regulatory supervision. Although the legislation does not specify GMP adaptations, these sandboxes could create environments where regulatory expectations are clarified or assessed in a controlled setting.
• The new requirement for shortage prevention plans strengthens the regulatory expectation that companies maintain robust supply and risk-management systems. While not specified as GMP obligations, these measures will likely influence how manufacturers integrate supply-chain risk management into their quality systems.
• Many of the new obligations introduce additional ongoing responsibilities for marketing authorisation holders. While the legislation does not explicitly address GMP or quality-system expectations, these measures will likely require both MAHs and manufacturers to update processes and maintain oversight throughout the product lifecycle.
• Conditions for the Qualification of a Qualified Person are now summarised in the Annex to the Proposal for a Directive but do not bring a real relief.