European Regulators Prepare the Pharma Industry for Future Changes as Legislation is Formalized

Since July 2026, the European Union (EU) has shifted its focus from legislative reforms to practical applications, prioritizing supply-chain resilience, preventing medicine shortages, streamlining regulations, artificial intelligence (AI) governance, and introducing innovative approaches for non-clinical drug development.

Key updates for pharma and biotech include implementing the AI Act, expanding regulatory reliance on post-authorization changes (PACs), implementing new pharmaceutical regulations, and addressing medicine shortages and supply-chain robustness. Additionally, the European Medicines Agency (EMA) continues to promote regulatory reliance and faster clinical development pathways, supported by a new pilot program for New Approach Methodologies (NAMs).

Enforcement of the AI Regulation

Enforcement of the AI Act began on August 2, 2026, creating a framework and implementing new transparency standards for specific generative, interactive AI systems, and AI-produced content.1-3 Additional regulations for other high-risk applications will take effect in December 2027, with further high-risk requirements postponed until August 2, 2028 under the AI Omnibus.4 This delay significantly affects the pharmaceutical sector’s AI usage in areas such as research and development (R&D) (including AI-supported drug discovery and diagnostics), manufacturing and process optimization (covering generative AI in regulated workflows and quality systems), pharmacovigilance (such as regulatory intelligence and medical information), and clinical development (AI-enabled decision-support tools, clinical trial recruitment, and optimization). The pharma industry must continue to focus on establishing governance, transparency, and accountability for AI systems across the entire value chain.5

EMA Expands Regulatory Reliance for Post-Authorization Changes

On August 13, 2026, the EMA released updated guidance for industry regarding the reliance pilot for PACs, including a mid-pilot review.6 The aim is for EU regulators to leverage evaluations already conducted by trusted authorities elsewhere, preventing redundant assessments. This approach could lower administrative burdens for multinational firms, accelerate review timelines, reduce duplicated efforts across jurisdictions, and ease overall regulatory workloads. The PAC pilot initiative is a component of a wider strategy to foster international regulatory convergence and reliance. For global pharmaceutical companies, this could significantly streamline their supply chain, manufacturing processes, and post-approval lifecycle management.

Prioritizing Medicine Shortages and Strengthening Supply-Chain Resilience

On August 31, 2026, the EMA released a new Shortage Prevention Plans (SPP) template and revised its industry guidance on SPP implementation.7 This development is crucial because the upcoming EU pharmaceutical framework will focus more on manufacturers and marketing-authorization holders proactively identifying and addressing vulnerabilities to prevent shortages.The SPP approach urges pharma companies to systematically consider factors such as alternative manufacturing options, API and raw material risks, business continuity plans, logistical vulnerabilities, dependencies on manufacturing sites, mitigation strategies, and potential supply chain vulnerabilities.

EU regulators increasingly view manufacturing diversification as a regulatory and public health goal. For manufacturers, dependence on a single API source or manufacturing location is becoming a significantly more important regulatory factor. The EMA's initiatives support the broader EU Critical Medicines Act, which seeks to increase production capacity, diversify supply chains, and reduce dependence on particular suppliers.8

Pilot Project for NAMs

On September 1, 2026, the EMA launched a pilot program, Voluntary Data Submission, to collect data on NAMs.9 These include techniques such as organoids, microphysiological systems, computational models, and other innovative in vitro methods, including integrated approaches. Companies, clinical research organizations, labs, and method developers can submit NAM data independently of marketing applications for non-binding regulatory feedback. The pilot will help the EMA gain experience in evaluating these technologies before wider regulatory use. If this pilot succeeds, it could impact pharma R&D by accelerating the use of organoid models, reducing animal testing, and potentially improving preclinical data and predictions, while encouraging more funding for biotech, cell therapies, computational biology, and innovative drug firms.

In July 2026, the EMA published the non-clinical requirements concept paper for severe diseases.10 The consultation for this program concludes on September 30, 2026, and a reflection paper will be released afterwards to align non-clinical development and facilitate earlier access to life-saving medicines. The paper will emphasize the 3Rs—replacing, reducing, and refining animal models whenever feasible.

Faster Multinational Clinical-Trial Assessment

EU regulators acknowledge that making the Clinical Trials Regulation (CTR) faster and more predictable is essential for Europe to stay competitive in innovative clinical research. In July 2026, the EMA held a Clinical Trials Information System (CTIS) training session on how to use the new annual safety reporting (ASR) module, which will become the mandatory channel for submitting and managing ASRs from go-live.11 Earlier in the year, the Heads of Medicines Agencies launched the Facilitating and Accelerating Strategic Clinical Trials European (FAST-EU) pilot to expedite the evaluation of multinational clinical trials under the EU CTR.12 This program provides a coordinated fast-track review process designed to reduce timelines and enhance predictability among Member States.

Formal Adoption of EU Pharma Package

The EU’s largest pharma regulatory overhaul in 2 decades is nearing adoption. It consists of a new Regulation and a new Directive, which will replace the current framework (Directive 2001/83/EC and Regulation (EC) No 726/2004). In December 2025, the Council and European Parliament (CEP) reached a political agreement on a new pharmaceutical framework, which is now moving forward in the legislative process.13 Although not yet officially in effect, the legislation covers regulatory protections, market access, shortages, antimicrobial resistance, orphan and pediatric medicines, and regulatory procedures. As a result, companies should start preparing for upcoming changes in regulatory incentives, supply obligations, procedures, and market access, as well as the link between EU regulatory approval and actual market availability. The revised framework is expected to become fully operational around 2028, at least for the main provisions.14

Enhancing Innovation Within the EU

In September 2026, the European Commission (EC) proposed a new European Innovation Act to support the development, funding, and scaling of Europe’s most innovative ideas.15 To strengthen the EU innovation system, the proposal addresses 2 main challenges. First, it seeks to boost access to funding for innovative businesses by providing up to €10.2 billion (US$11.85 billion) extra each year and reducing about €35 million (US$40.67 million) in administrative costs. Secondly, it will create a unified framework for R&D procurement, enhancing legal clarity. This will help technologists bring products to market more efficiently and make it easier for EU buyers to participate in joint R&D procurement. As a result, companies could see an increase of €25.92 billion (US$30.12 billion) in annual profits, and public buyers could save €1 billion (US$1.16 billion) annually.

Future Outlook ofEU Regulation on the Pharma Industry

Between July and September 2026, the EU’s pharma and biotech regulation landscape emphasized digitalization and AI, fostering innovation through regulation, enhancing regulatory efficiency, and strengthening supply chains. The emphasis has moved from a primarily product-focused regulatory approach to prioritizing EU competitiveness, resilience, and strategic independence. Additionally, upcoming guidance on the AI Act will delineate the distinctions among general-purpose AI, medical devices, and AI integrated into regulated products. The EMA’s NAM pilot program will evaluate whether organoids, computational models, and other alternatives can gain wider regulatory approval. Furthermore, FAST-EU performance data are expected to speed up clinical trial assessments.

During the next 12 months, the industry will integrate the EU Pharma Package and new pharmaceutical regulations into its operations. For innovative biotech firms, key changes will involve FAST-EU, NAM, and regulatory reliance initiatives. Meanwhile, established pharmaceutical companies are likely to face significant operational changes related to shortage prevention, pharmacovigilance, and implementing the EU Pharma Package.

References

1. Commission starts enforcing AI Act rules and new transparency requirements on 2 August. European Commission. July 31, 2026. Accessed September 10, 2026. https://digital-strategy.ec.europa.eu/en/news/commission-starts-enforcing-ai-act-rules-and-new-transparency-requirements-2-august
2. Guidelines on transparency obligations for providers and deployers of certain AI systems. European Commission. July 20, 2026. Accessed September 10, 2026. https://digital-strategy.ec.europa.eu/en/library/guidelines-transparency-obligations-providers-and-deployers-ai-systems
3. The enforcement framework of the AI Act. European Commission. August 24, 2026. Accessed September 10, 2026.https://digital-strategy.ec.europa.eu/en/policies/enforcement-ai-act
4. Regulation (EU) 2026/1744 of the European Parliament and of the Council amending Regulations (EU) 2024/1689, (EU) 2018/1139 and (EU) 2023/1230 as regards the simplification of the implementation of harmonised rules on artificial intelligence (Digital Omnibus on AI). European Commission. July 8, 2026. Accessed September 10, 2026. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202601744
5. Transparency obligations under Article 50 of the AI Act. European Commission. July 24, 2026. Accessed September 10, 2026. https://digital-strategy.ec.europa.eu/en/faqs/transparency-obligations-under-article-50-ai-act
6. Reliance pilot for post-authorisation changes: guidance for industry and mid-pilot review. European Medicines Agency. 2026. Accessed September 10, 2026. https://www.ema.europa.eu/en/documents/report/reliance-postauthorisation-changes-pacs-mid-pilot-review_en.pdf
7. Guidance for industry on shortage prevention plans. European Medicines Agency. July 17, 2026. Accessed September 10, 2026. https://www.ema.europa.eu/system/files/documents/regulatory-procedural-guideline/guidance-industry-implementing-shortage-prevention-plans-en.pdf
8. Critical Medicines Act. European Commission. March 11. 2025. Accessed September 10, 2026. https://ec.europa.eu/commission/presscorner/detail/en/ip_25_733
9. Voluntary data submission pilot to advance innovative alternatives to animal testing. European Medicines Agency. September 1, 2026. Accessed September 10, 2026. https://www.ema.europa.eu/en/news/voluntary-data-submission-pilot-advance-innovative-alternatives-animal-testing
10. Concept paper on the development of a reflection paper on the non-clinical requirements for severely debilitating or life-threatening diseases. European Medicines Agency. July 30, 2026.Accessed September 10, 2026.https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-reflection-paper-non-clinical-requirements-severely-debilitating-or-life-threatening-diseases_en.pdf
11. Presentation CTIS training environment: Updated access process and safety module instructions. European Medicines Agency. July 23, 2026. Accessed September 10, 2026. https://www.ema.europa.eu/en/documents/presentation/presentation-ctis-training-environment-updated-access-process-safety-module-instructions-ornela-ademi_en.pdf
12. Fast-EU. European Medicines Agency. March 3, 2026. Accessed September 10, 2026. https://ec.europa.eu/newsroom/ema/items/925543/en
13. Reform of EU pharmaceutical legislation. European Commission, Directorate-General for Health and Food Safety. European Commission. December 2025. Accessed September 10, 2026. https://health.ec.europa.eu/medicinal-products/reform-eu-pharmaceutical-legislation_en
14. The EU Pharma Package is finally here – here's the settled position on key areas. Herbert Smith Freehills Kramer. Global law firm. April 26, 2026. Accessed September 10, 2026. https://www.hsfkramer.com/notes/ip/2026-04/the-eu-pharma-package-finally-here-what-it-changes-and-what-it-means
15. Commission proposes new European Innovation Act to help innovative European ideas grow and compete globally. European Commission. Press release. September 9, 2026. Accessed September 10, 2026. https://ec.europa.eu/commission/presscorner/detail/en/ip_26_1810