Publication date: February 2, 2026
The European life science sector is entering a phase of profound and systemic regulatory changes that will significantly impact research, innovation development, and commercialization in the coming years. On January 29, 2026, our colleague, Zofia Kubic had the opportunity to participate in the LifeScience Kraków Cluster meeting, representing the KG Legal Kiełtyka Gładkowski law firm, a member of the cluster. During the meeting, key European Union initiatives were discussed, setting a new direction for pharmaceutical, biotechnology, and medical device manufacturers.
The meeting focused on the practical implications of the planned changes and their impact on the business and scientific strategies of entities operating in the European market.
The first pillar of the reforms discussed was the new EU Pharmaceutical Package, which introduces significant changes in the protection of innovation and drug safety. A key element is the new standard of data exclusivity based on the 8+1 system. For the first eight years, competitors cannot even submit a registration application, and despite the possibility of submitting one after this period, marketing the drug remains impossible until the ninth year. The new protection model provides for a modulation mechanism that links the duration of exclusivity to the real value of the innovation, moving away from the previous principle of unitary protection regardless of its significance. In this way, the European Union “pays” for innovation with an additional period of market exclusivity.
The changes also apply to orphan drugs, for which a new protection system has been introduced – shortened to nine years but enriched with bonuses for breakthrough therapies, while limiting incentives to duplicate existing solutions. Another significant new feature is the introduction of transferable vouchers for market exclusivity for producers of priority antibiotics. These vouchers can be sold to other companies and are a tool dedicated primarily to the small and mid- market segments. The system is equipped with safeguards, such as a ban on granting vouchers for non-essential innovations, a ” blockbuster ” clause excluding their use for drugs with annual EU sales exceeding €490 million, and a limited number of available vouchers.
The pharmaceutical package also introduces a new approach to drug safety, placing responsibility for supply continuity directly on marketing authorization holders. Manufacturers will be required to provide six months’ notice of planned product recalls or anticipated supply disruptions and to implement plans to prevent shortages. Each entity will be required to maintain a “safety portfolio”, including a complete inventory of risks, supply sources, and storage buffers.
The second pillar of change is European Biotech Act, which introduces a broad, new definition of healthcare biotechnology and a risk-based regulatory approach. Two project development paths are envisaged, including strategic project status, providing priority access to authorities, regulatory sandboxes, and financial instruments such as an investment pilot with the European Investment Bank. Regulatory sandboxes are intended to enable testing of technologies that anticipate existing regulations, eliminating decision-making paralysis and providing a temporary “suspension” of certain legal requirements under a security umbrella.
Revolutionary changes also apply to administrative procedures. Significant shortening of deadlines is planned – standard procedures will be shortened from 75 to 47 days, procedures involving inquiries from 106 to 75 days, and in the case of advanced ATMP therapies, the previous 50-day period for case review by offices will be eliminated.
The third area of reform is the revision of the MDR and IVDR regulations for medical devices. A key change is the shift from the rigid requirement for full recertification of devices every five years to a continuous monitoring model. Supervisory authorities will not re-examine the entire documentation unless the device has undergone significant changes – in which case, the new requirements will apply only to the modified elements. This solution is intended to significantly reduce administrative costs for manufacturers.
Additionally, specific changes regarding orphan devices were announced, including the introduction of a legal definition and a move away from treating them on an equal footing with other medical devices. Reductions in administrative fees were also planned, which is intended to facilitate market access for such solutions.
The meeting allowed participants to better understand upcoming regulatory changes, identify potential opportunities for their own projects, and prepare organizations for new legal challenges. Particular emphasis was placed on the practical implications of the reforms and their importance for long-term business and scientific strategies in the life sciences sector. It was repeatedly emphasized that it is important to monitor current regulations and not wait until the last minute to implement them.