The reform of the European pharmaceutical package, the regulation of artificial intelligence in drug development, and the tightening of rules on shortages are reshaping the regulatory framework for laboratories operating in France and Europe. We provide an overview of the structural changes for 2025-2026 and their operational consequences for the pharmaceutical industry.
European pharmaceutical package: what the regulatory overhaul means for laboratories
The European Union is preparing the largest overhaul of its pharmaceutical legislation in over twenty years. A political agreement was reached at the end of 2025, with formal adoption expected in 2026 and the implementation of most of the new regime starting in 2028.
You may also like : What is the average height of women in France by region?
This timeline requires laboratories to start adapting their market access processes now. The reform simultaneously affects data regulatory protection, marketing authorization (MA) procedures, shortage management, and industrial competitiveness.
On the MA front, the new framework shortens certain evaluation timelines for drugs addressing unmet medical needs. In return, post-authorization pharmacovigilance requirements are strengthened. For clinical trial sponsors, this means recalibrating regulatory files and more precise anticipation of follow-up obligations.
Recommended read : How to choose a suitable walker after hip replacement surgery?
The impact on orphan drugs deserves particular attention. The new framework reorganizes incentives for rare diseases, with a rebalancing between commercial exclusivity and obligations for effective availability in all member states. Laboratories positioned in this segment will need to review their pricing and market access strategies.
We recommend following Pharmavia’s updates to stay informed about regulatory milestones as the implementing texts become clearer.
Drug shortages in France: new supply obligations
European rules on supply continuity are tightening significantly. The new framework provides for three mechanisms that change the game for the operational management of laboratories and wholesalers.
- Earlier alerts in case of supply disruptions, with harmonized triggering thresholds at the European level, requiring accelerated information flow from production sites
- Mandatory contingency stocks for drugs deemed critical, with the list to be defined by each member state in coordination with the EMA
- Advance notifications before any marketing withdrawal, with an extended timeframe to allow health authorities to organize therapeutic alternatives
For retail pharmacies and hospital pharmacies, these measures should reduce the frequency of unannounced shortages. However, they increase the administrative burden for MA holders, who will need to implement more granular reporting systems.
The French market is particularly affected. France is among the European countries where supply tensions on certain therapeutic classes (eye drops, antibiotics, antiepileptics) have been recurrent in recent years. The strengthening of the European framework adds to the national measures already in place, such as the ANSM shortage plan.
Artificial intelligence and drug development: the EMA-FDA framework of 2026
The EMA and the FDA published in 2026 common principles of good practices for the use of AI in pharmaceutical development. This framework covers the generation of clinical evidence, trial monitoring, and the entire lifecycle of the drug.
This is not a legally binding text. However, for clinical trial sponsors, these principles effectively become the expected standard by evaluators during the review of MA files. Ignoring these recommendations poses a significant regulatory risk.
What the AI good practices cover
The framework focuses on the traceability of algorithms used in patient selection, analysis of endpoints, and detection of pharmacovigilance signals. Each AI model integrated into the regulatory file must be documented with its validation methodology.
For laboratories already using AI tools in their discovery phases or phase II-III trials, we observe an immediate need for documentation structuring. Regulatory teams must work upstream with data scientists to produce files that meet agency expectations.
Competitiveness of the European pharmaceutical industry against the United States and China
The European pharmaceutical package is set against a backdrop of Europe’s slowing pace in therapeutic innovation. Recent data shows a marked imbalance: the majority of new drugs now come from the United States and China, while the European share is declining.
The reform seeks to address this gap through several levers. The acceleration of MA procedures aims to make Europe more attractive for first global launches. New incentives for pharmaceutical SMEs and biotech companies aim to retain R&D investments on European soil.
The American market remains the largest global market by value, with drug prices significantly higher than in Europe. This price asymmetry continues to draw investments to the United States, where the return on investment is faster. European laboratories, particularly large groups like AstraZeneca or GSK, are adjusting their portfolios based on these market dynamics.
What role for France in this restructuring
France retains structural advantages: a healthcare system that guarantees broad access to medications, recognized academic clinical research, and a production industrial fabric. The challenge remains the speed of market access, where negotiation timelines for prices with the CEPS continue to hinder launches compared to Germany.
The coming months will be crucial to assess whether the European reform can reverse the trend. The formal adoption of the pharmaceutical package in 2026 will set the framework for the next decade. Laboratories that anticipate the new requirements now, regarding shortages and AI, will be better positioned in a rapidly changing regulatory environment.