backDecember 2025 marked an exceptionally active period for life sciences regulation in the European Union (EU). Within the space of a few days, EU institutions have reached political agreement on the most far-reaching reform of pharmaceutical legislation in over twenty years and unveiled a new EU Health Package encompassing biotechnology, medical devices, and cardiovascular health.
Together, these initiatives significantly reshape the regulatory landscape for pharmaceutical, biotech, and medical device companies operating in, or targeting, the EU market. This alert provides a high-level summary of the key elements of all initiatives and outlines what companies should be preparing for.
EU Pharmaceutical Package – Political Agreement Reached
1. Status and Timing:
On December 11, 2025, the European Parliament, Council, and Commission reached a provisional political agreement on the revision of the EU General Pharmaceutical Legislation (Revision), comprising a new Directive and a new Regulation that will replace the current Directive 2001/83, Regulation 726/2004, Orphan Regulation, and Paediatric Regulation.
The consolidated legal texts have not yet been published. Following their technical finalization, legal-linguistic review, and translation, formal adoption is expected in Q2 2026. Most of the new provisions will apply beginning mid-2028, subject to transitional arrangements. A substantial number of delegated acts, implementing acts, and guidelines is expected ahead of the application.
2. Key Changes to Incentives
Data Exclusivity and Market Protection: The Revision replaces the long-standing “8+2(+1)” framework with a modulated incentive structure.
- Baseline protection: 8-year data exclusivity (DE) and 1-year market protection (MP)
- Extensions:
- 1 more year MP where (i) at initial authorization, the medicinal product addresses an unmet medical need; or (ii) contains a new active substance and meets cumulative conditions relating to EU-based comparative trials, multinational clinical development, and early EU MA application.
- 1 further year MP where a new indication bringing a significant clinical benefit is authorized during the DE period.
- Overall cap: the total regulatory data and market protection is capped at 11 years.
Orphan Medicinal Products: the Revision provides a standard 9-year orphan exclusivity (reduced from 10 years currently), which can increase to 11 years for breakthrough orphan medicinal products. A medicinal product may qualify as a “breakthrough” orphan if (i) no authorized treatment exists in the EU for the condition; and (ii) the product delivers a clinically meaningful reduction in morbidity or mortality. Further clarifications are expected on this new concept. Orphan products relying on well-established medical use will benefit from shorter exclusivity.
Antimicrobial Resistance Incentive: To address antimicrobial resistance (AMR), the Revision introduces a transferable data exclusivity voucher that provides a one-time 12-month extension of data exclusivity. The extension can benefit the qualifying antimicrobial or another centrally (EU) authorized medicinal product (including from a different marketing authorization holder), subject to a sales threshold.
3. Other Important Provisions
Obligation to Market: This obligation has been proposed by the Council (Art.56a), but it remains unclear from the information released by the authorities so far whether the key provisions of this article have been kept. In essence, Member States would be empowered to require companies to supply (presumably by submitting applications for pricing and reimbursement, participating in public procurement procedures, or setting-up a roll-out plan) medicinal products benefiting from regulatory protection in sufficient quantities to meet the national patient needs. Where a MAH fails to comply with the request within the defined time period (presumably three years), MP may be lost in the requesting Member State, opening the door earlier to generic or biosimilar entry.
Expanded Bolar Exemption: The Bolar exemption is expressly broadened to cover preparatory activities beyond regulatory submissions, including health technology assessments, pricing and reimbursement procedures, and procurement and tender participation. This expansion will allow generic and biosimilar products to be ready for launch immediately upon expiration of intellectual property protection.
Shortages: The Revision significantly strengthens shortage mitigation and prevention measures:
- mandatory shortage prevention plans for all prescription-only medicinal products (and additional products designated by the Commission);
- advance notification (generally six months) of anticipated supply disruptions;
- enhanced EU coordination mechanisms, including an EU list of critical medicines and assessment of supply chain vulnerabilities.
These measures will operate alongside the forthcoming Critical Medicines Act.
Faster Authorization Timelines: The EMA’s Committee for Medicinal Products for Human Use (CHMP) opinion timeline for marketing authorization in centralized procedures will be reduced from currently 210 to 180 days. The time period for the final decision by the EU Commission will also be shorter.
Regulatory Sandbox: The Revision introduces several mechanisms to support innovation including the possibility for the EU Commission to establish regulatory sandboxes to test, under a specific plan and strict and direct supervision of regulatory authorities, innovative products that cannot be developed under the existing regulatory requirements. Such controlled frameworks will allow developers to test innovative products under enhanced regulatory guidance and temporary regulatory flexibilities.
European Medicines Agency - EMA Governance: The Revision introduces a separation between scientific advice and marketing authorization evaluation (as to the extent possible, same evaluators must not be used). In addition, the role of patients and healthcare professionals is enhanced, including voting rights in certain EMA processes.
EU Health Package – New Legislative Proposals
On 16 December 2025, the EU Commission unveiled a broad EU Health Package comprised of (i) a proposed EU Biotech Act, (ii) proposed amendments to the EU Medical Devices Regulation (MDR) and EU IVD Regulation (IVDR); and (iii) a new Safe Hearts Plan on cardiovascular disease. These proposals aim to boost competitiveness, reduce regulatory burdens and complexities, and accelerate patient access.
1. The EU Biotech Act
The proposed EU Biotech Act seeks to strengthen the EU’s biotechnology ecosystem by accelerating translation from laboratory to market, reducing regulatory complexity, improving access to finances through a new health biotech investment pilot, and incentivizing EU-based R&D and manufacturing.
The Biotech Act consists of (i) a Regulation on establishing a framework of measures for strengthening EU’s biotechnology and biomanufacturing sectors particularly in the area of health; and (ii) a Directive on the placing on the market of genetically modified micro-organisms and the processing of organs. The Regulation and Directive focus on the pharmaceutical sector, and they together form Part I of the Biotech Act. The second part of the Biotech Act, which will focus on biotech in general, is expected next year.
Intellectual Property: The EU Biotech Act proposes a 12-month supplementary protection certificate (SPC) extension for certain biotech-derived medicines and ATMPs, subject to strict criteria, including a new active substance and mechanism of action, multinational EU clinical trials (clinical trial evaluating efficacy in more than two EU Member States), and performance of at least one manufacturing step (excluding packaging, quality testing and certification) within the EU. Eligibility would be assessed by the EMA as part of the MA procedure.
Clinical Trials: The EU Biotech Act proposes targeted amendments to the EU Clinical Trials Regulation that aim at reversing Europe’s declining share of global trials by:
- cutting authorization timelines for multi-national clinical trials. End to end timeline reduced from 75 to 47 days where no further information is requested (from submission to decision) and from 106 days to 75 (including validation and ethical review) where further information is requested. Also, the additional 50 days for assessing ATMPs will be removed;
- reducing the assessment period for substantial modifications from 64 to 33 days where no further information is requested and from 96 days to 47 days where further information is requested, with options for parallel substantial modifications;
- strengthening the leading role of the reporting Member State by increasing its responsibilities for the assessment and reinforcing reliance to reduce duplication;
- introducing a new category of “minimal-intervention clinical trials” to simplify and reduce the requirements for even lower intervention trials;
- establishing regulatory sandboxes for innovative trial designs, including AI-enabled and decentralized trials.
Another major innovation is the creation of a single integrated assessment process for combined studies involving medicinal products and medical devices or IVDs, replacing the current parallel and fragmented national procedures.
Other Important Provisions
The EU Biotech Act proposes a modernization of the EU ATMP rules, including environmental risk exemptions, recognition of ATMP Centers of Excellence, and measures addressing biosecurity and preventing misuse of biotechnology. The scope of the regulatory sandbox introduced by the future Regulation (pharma package) will be significantly expanded to cover medical devices, IVDs, and products under the recently adopted EU Substances of Human Origin (SoHO) Regulation.
The proposed Directive concerns GMO and the processing of organs.
2. Revision of the MDR and IVDR
The EU Commission proposed targeted amendments to simplify and stabilize the MDR and IVDR including:
- adjustments to the classification rules for (i) medical device software to classify some such software as Class I and thereby remove the assessment by a Notified Body; (ii) reusable surgical instruments; and (iii) accessories to active implantable devices;
- removal of the five-year cap on the validity of EU certificates of conformity, instead Notified Bodies will carry out periodic reviews proportionate to the risk of the device;
- more flexible rules for in-house devices (LTD manufactured and used in health institutions), e.g. allowing the transfer of in-house devices (under the IVDR) outside the initial health institution and adding central laboratories manufacturing and using tests exclusively for clinical trials to the scope of the in-house device exemption;
- regulatory sandboxes for emerging technologies to test new products in a controlled environment without immediately facing all the usual regulatory compliance requirements;
- new priority and rolling review pathways for orphan and breakthrough devices after designation by an expert panel;
- the scope of the clinical evaluation consultation procedure (MDR) will be limited to Class III implantable devices (the EU Commission may add other devices). The performance evaluation consultation procedure and early advice (IVDR) will be replaced by the possibility of early advice from expert panels for Class C and D IVDs;
- streamlined clinical investigation and performance study requirements; and
- greater international regulatory reliance on audits of quality management systems e.g. Medical Device Single Audit Programme (MDSAP).
A stronger coordinating role for the EMA and European monitoring of device shortages are also foreseen.
What Comes Next
The EU pharmaceutical package - Revision now entered its finalization and formal adoption stage while the EU Biotech Act and the revision of the MDR and IVDR still are legislative proposals that will be negotiated by the EU Parliament and Council and will be amended. Extensive secondary legislation and guidance are expected across all initiatives.
Companies should be aware of the evolutions of the EU legal framework and anticipate their impacts on current development and investment. We will continue to monitor developments closely and provide further analysis as official texts become available.
King & Spalding’s regulatory Life Sciences lawyers can help you better understand the changes that may result from the Revision and the EU Health Package and anticipate their impact on the development and marketing of medicinal products, medical devices, and SoHO products in Europe.