On 11 December 2025, the European Parliament and the Council of the European Union (EU) reached a political agreement on reforming the EU’s pharmaceutical legislation.

 This is the most significant overhaul of the regulatory framework in more than 2 decades and will help Europe modernize the development and authorization of medicines across the EU.

What Is the New Pharmaceutical Legislation?

The new pharmaceutical legislation replaces the existing legislation for human medicines (Regulation [EC] No 726/2004 and Directive 2001/83/EC), including those for children and rare diseases (Regulation [EC] No 1901/2006; Regulation [EC] No 141/2000).

 In addition, the new legislation introduces a series of targeted amendments to the advanced therapy medicinal products (ATMP) regulation (Regulation [EC] No 1394/2007), the clinical trials regulation (Regulation [EU] No 536/2014), and the European Medicines Agency’s (EMA’s) extended mandate regulation (Regulation [EU] 2022/123).

The new pharmaceutical legislation is designed to, as follows:

•address major public health challenges, including antimicrobial resistance

•adapt the EU regulatory framework to support digitalization and foster innovation

EMA will provide regular updates throughout 2026 on the changes introduced. The new legislation will focus on several areas to support innovation and reduce procedural complexities and administrative burdens, particularly in paediatric and rare disease medicines. It will review medicine shortages and the environmental sustainability of medicines and amend the structure of the EMA scientific committees to improve efficiency and the evaluation of medicines.

The new pharmaceutical legislation will enter into force in 2026, with the following 2 years serving as a transition period to allow EU Member States to align their national laws with the new rules. The European Commission (EC), EMA, and EU Member States will provide implementation guidance to stakeholders in 2026 (

On 12 January 2025, the EU Health Technology Assessment (HTA) regulation came into effect for oncology and ATMPs, with all new medicinal products to be incorporated from 2030 onward.9 The regulation ensures a scientifically based, evidence-driven, multidisciplinary approach to evaluating the relative effectiveness and additional benefit of health technologies compared with existing alternatives. The main objectives are to:

•harmonize clinical assessment methodologies across the EU

•reduce duplication of national assessments

•expedite patient access to innovative therapies

•support sustainable health care systems by providing robust evidence for decision-making.

This marks a major shift in the assessment of health technologies, with clinical evaluations now conducted at the EU level through the joint clinical assessment, which will run in parallel with the EMA process. The EU HTA regulation aims to expedite patient access, reduce duplication of effort across Member States, and harmonize the methodologies used for clinical evaluation.

In October 2025, Regulation (EU) 2025/2086 came into force, significantly affecting the healthcare sector in the EU. It further streamlines the HTA process for medical and in vitro diagnostic devices and is expected to enhance the efficiency and consistency of HTAs. It will benefit patients and health care providers by providing clearer, more reliable information on the effectiveness and safety of new health technologies. 

How Is the UK Aligning Marketing Authorization and HTA Recommendations?

As of April 2026, the pharmaceutical industry will be able to use the Integrated Scientific Advice service from the Medicines and Healthcare products Regulatory Agency and the National Institute for Health and Care Excellence to obtain UK marketing authorization and HTA recommendations in parallel.

 The joint scientific advice service will provide companies with greater clarity on evidence requirements and more predictable timelines, thereby avoiding unnecessary delays. It should help reduce the time to patient access by 3 to 6 months.

The aligned pathway will be optional for companies with eligible drugs. If preferred, companies can request a later submission date and use the traditional sequential approach. This flexibility may be appealing where global development programmes or regulatory timelines do not align with the earlier submission requirements.

What Are the Implications for European Pharma?

The EU and the UK continue to update legislation to ensure competitiveness and expedite patient access to innovative medicines. The new legislation and alignment of regulatory pathways should help harmonize regulation, reduce complexity and administrative burden, enhance operational efficiency, and drive the delivery of a sustainable health care system.

Reform of the EU pharmaceutical legislation. European Medicines Agency; 2025. Accessed 19 March 2026. ema.europa.eu

Regulation (EC) No 726/2004. European Medicines Agency; 2022. Accessed 19 March 2026.ema.europa.eu

Directive 2001/83/EC. European Medicines Agency; 2025. Accessed 19 March 2026.ema.europa.eu

Regulation (EC) No 1901/2006. European Medicines Agency; 2019. Accessed 19 March 2026.ema.europa.eu

Regulation (EC) No 141/2000. European Medicines Agency; 2025. Accessed 19 March 2026.ema.europa.eu

Regulation (EC) No 1394/2007. European Medicines Agency; 2019. Accessed 19 March 2026.ema.europa.eu

Regulation (EU) No 536/2014. European Medicines Agency; 2022. Accessed 19 March 2026.ema.europa.eu

Regulation (EU) 2022/123. European Medicines Agency; 2022. Accessed 19 March 2026.ema.europa.eu

Regulation (EU) 2021/2282. European Medicines Agency; 2021. Accessed19 March 2026.ema.europa.eu

Johns A, Andrade A, Johal S, Ryan J. EU joint clinical assessment: a framework for optimising use with cost-effectiveness decision-making. 

Chirico G. How are countries implementing the EU HTA regulation? An updated overview. Remap Consulting; 2025. Accessed 19 March 2026 https://remapconsulting.com/hta/how-are-countries-implementing-the-eu-hta-regulation-an-updated-overview/12.

Regulation (EU) 2025/2086. European Medicines Agency; 2025. Accessed19 March 2026.ema.europa.eu

Medicines: get integrated scientific advice from the MHRA and NICE. MHRA. GOV.UK; 2026. Accessed 19 March 2026.https://www.gov.uk/guidance/medicines-get-scientific-advice-from-mhra

Grubert N. Simultaneous UK marketing authorisation and HTA recommendation. LinkedIn. November 20, 2025. AccessedMarch 19, 2026. https://www.linkedin.com/posts/neil-grubert_uk-mhra-nice-activity-7382473273948807168-XNB_/.

Cheryl Barton, PhD, is founder and director of PharmaVision, Pharmavision.co.uk.

When referring to this article, please cite it as Barton C. The impact of new pharmaceutical and HTA legislation in Europe. 

Articles

Europe is implementing sweeping reforms to medicine regulation and health technology assessment, with major implications for oncology, ATMPs, paediatric and orphan products. A new EU pharmaceutical legislative package will replace core human medicines rules, amend ATMP and clinical trials frameworks, and update EMA committee structures, while also addressing antimicrobial resistance, shortages, sustainability, and digitalization. In parallel, EU-level joint clinical assessment for HTA is now live for oncology and ATMPs and will expand to all new medicines by 2030. The UK is introducing optional parallel MHRA–NICE advice to compress access timelines.

Regulatory Watch

New legislation will improve patient access to innovative medicines in Europe and the United Kingdom.

The Impact of New Pharmaceutical and HTA Legislation in Europe

Momentum is building for proteolysis-targeting chimeras (PROTAC) treatments that hijack the ubiquitin-proteasome system (UPS) to catalytically degrade pathogenic proteins and eliminate disease-causing proteins.

 This approach enables scientists to target previously "undruggable" proteins and exert sustained pharmacological effects, including those responsible for difficult-to-treat childhood cancers and drug-resistant triple-negative breast cancer.

 In recent years, significant progress has been made in the selective delivery of PROTACs, potentially extending their use to a broader range of conditions.

How is the pharma industry investing in proteasome-targeting therapies?

A number of proteasome-targeting therapies have been approved in Europe and the United States, such as Amgen’s   carfilzomib (Kyprolis), Bristol Myers Squibb’s ixazomib (Ninlaro), and Johnson & Johnson/Takeda’s bortezomib (Velcade). Several Big Pharma companies—AbbVie, AstraZeneca, Eli Lilly, Merck & Co, Novartis, Pfizer, Roche, and Sanofi—have products in clinical development. Interest in this field has catalyzed some interesting acquisitions and partnerships. For instance, in 2025, Johnson & Johnson completed its acquisition of Halda Therapeutics to gain access to its novel Regulated Induced Proximity Targeting Chimaeras (RIPTACs), a protein degradation approach that connects with proteasome pathways.

 In September 2025, Novartis initiated a collaboration with US-based Monte Rose to develop novel degraders or molecular glues to treat immune-mediated diseases.

Several biotech companies in the US are developing second-generation PROTACs, including Arvinas' vepdegestrant (ARV-471). In March 2025, Pfizer and Arvinas announced positive topline results from the phase 3 VERITAC-2 clinical trial with vepdegestrant in metastatic breast cancer.

 Additionally, C4 Therapeutics and Nurix Therapeutics have protein degrader programs: cemisoldomide in phase 1/2 for multiple myeloma/non-Hodgkin lymphoma (NHL), and bexobrutideg in phase 2/3 for relapsed/refractory chronic lymphocytic leukaemia (R/R CLL), respectively.

More recently, US-based Kymera Therapeutics received fast track designation from the US FDA for KT-621, an oral signal transducer and activator of transcription 6 (STAT6) degrader for the treatment of atopic dermatitis.

In 2025, Sanofi modified its collaboration with Kymera, discontinuing development of KT-474, an Interleukin-1 receptor-associated kinase 4 (IRAK4) degrader, while continuing development of KT-485, which is in phase 2 trials for atopic dermatitis and hidradenitis suppurativa.

 Other US biotech companies working in this field include Accutar Biotech, Cleave Therapeutics, Dialectic Therapeutics, and Karyopharm Therapeutics.

What are some European players to watch out for in the proteasome space?

Several European biotechs are evaluating a new class of inhibitors that harness the UPS, hijacking the proteasome to provide disease-specific protein degradation with a wide range of therapeutic applications from autoimmune to oncology.

has developed its proprietary next-generation targeted protein degradation (TPD) technology to develop Targeted Glues. Its lead program, AMX-883, can induce BRD9 degradation to block patient-derived tumour growth in vivo as a monotherapy, with superiority to venetoclax in acute myeloid leukaemia (AML).

focuses on developing small-molecule proteasome activators for neurodegenerative disease using its DGRADX platform. In October 2025, the company completed a US$15 million financing round led by life sciences investors Apollo Health Ventures and Novo Holding.

 Funds will be used to advance its multidisease pipeline.

focuses on the development of precision medicine using site-restricted targeted therapeutics. OncoOne’s research encompasses the development of targeted immunotherapeutics that modulate tumour degradation using its Pre-Targ-it platform. The company is exploring therapies that target the proteasome-Bcl-2 axis as novel anticancer agents.

QLi5 Therapeutics GmbH (German-Korean joint venture) 

is working on a new class of proteasome inhibitors that demonstrate strong anti-tumour and anti-inflammatory activity, offering promise in cancer, autoimmune, and inflammatory disorders.

 In September 2025, Qli5 closed a €10 million (US$12 million) Series A financing round with an international consortium of investors, including SV Investment (Korea), KHAN Technology Transfer Fund I (Germany), Atinum Investment (Korea), and DAOL Investment (formerly KTB, Korea). The proceeds will advance its pipeline of proteasome inhibitors in clinical development.

Future opportunities in targeting the proteasome

According to market research, the global proteasome inhibitor market was valued at approximately US$2.7 billion in 2024 and is projected to reach US$3.03 billion in 2024, growing to approximately US$6.1 billion by 2034, with a compound annual growth rate of 8.70% from 2025 to 2034.

 Preliminary research indicated that proteasomes may have far-reaching effects and could be used to target new immune defence mechanisms.

 Currently, companies are focusing on developing proteasome inhibitors for oncology; however, these agents may also present new opportunities to treat patients with inflammatory and autoimmune diseases. Many large pharmaceutical companies have already forged strategic partnerships with research institutions and biotech companies to advance PROATCs and UPS, either as standalone therapies or in combination with existing therapies. Several late-stage clinical trials will read out over the next 12 to 24 months, and promising results could stimulate further investment in this area.

Fu Z, Pan M, Yang C, et al. Rational modification of PROTACs for tumor-selective protein degradation. 

. 2026;230:115775. doi:10.1016/j.addr.2026.115775

Garber K. How protein-slayer drugs could beat some of the cruellest cancers. 

. 2025;641(8062):300-302. doi:10.1038/d41586-025-01350-2

Lee CH, Nguyen TM, Lee Y, et al. Overcoming therapeutic resistance in triple-negative breast cancer: targeting the undrugged kinome. 

. 2025;27(1):450. doi:10.3390/ijms27010450

Yang X, Wang D, Li C, et al. Nano-PROTACs for precision medicine: engineering strategies for enhanced targeting and potency. 

 2026;24(1):120. doi:10.1186/s12951-025-03985-9

 Johnson & Johnson completes acquisition of Halda Therapeutics and its novel platform to revolutionize cancer treatment and enable next-generation oral therapies. Press release. Halda Therapeutics. Published December 29, 2025. Accessed February 19, 2026. 

https://haldatx.com/johnson-johnson-completes-acquisition-of-halda-therapeutics-and-its-novel-platform-to-revolutionize-cancer-treatment-and-enable-next-generation-oral-therapies

Monte Rosa Therapeutics announces collaboration with Novartis for degraders to treat immune-mediated diseases. Press release. Monte Rosa Therapeutics. Published September 15, 2025. Accessed February 19, 2026. 

https://ir.monterosatx.com/news-releases/news-release-details/monte-rosa-therapeutics-announces-collaboration-novartis

 Arvinas presents preclinical data supporting mechanistic synergies and enhanced antitumor activity with the combination of ARV-393 and glofitamab at the 2025 American Society of Hematology Annual Meeting and Exposition. Press release. Arvinas. Published December 6, 2025. Accessed February 19, 2026. 

https://ir.arvinas.com/news-releases/news-release-details/arvinas-presents-preclinical-data-supporting-mechanistic

Cemsidomide. C4 Therapeutics. Accessed January 13, 2026. 

https://c4therapeutics.com/our-pipeline/cemsidomide/

Nurix Therapeutics outlines 2026 goals and objectives for advancing bexobrutideg and its pipeline of novel degrader-based medicines in cancer and autoimmune diseases. Press release. Nurix Therapeutics. Published January 12, 2026. Accessed January 13, 2026. 

https://ir.nurixtx.com/news-releases/news-release-details/nurix-therapeutics-outlines-2026-goals-and-objectives-advancing

Arvinas and Pfizer announce positive topline results from phase 3 VERITAC-2 clinical trial. Press release. Pfizer. Published March 11, 2025. Accessed January 13, 2026. 

https://www.pfizer.com/news/press-release/press-release-detail/arvinas-and-pfizer-announce-positive-topline-results-phase

Kymera Therapeutics announces U.S. FDA fast track designation for KT-621, a first-in-class, oral STAT6 degrader for the treatment of atopic dermatitis. Press release. Kymera Therapeutics. Published December 11, 2025. Accessed January 13, 2026. 

https://investors.kymeratx.com/news-releases/news-release-details/kymera-therapeutics-announces-us-fda-fast-track-designation-kt

Kymera Therapeutics announces Sanofi IRAK4 collaboration. Press release. Kymera Therapeutics. Published June 25, 2025. Accessed January 13, 2026 .

https://www.globenewswire.com/news-release/2025/06/25/3104958/0/en/Kymera-Therapeutics-Announces-Sanofi-IRAK4-Collaboration-Update.html

Amphista Therapeutics presents new preclinical data showing the potential of its BRD9 targeted glue, AMX-883, to transform the treatment paradigm for acute myeloid leukaemia. Press release. Amphista Therapeutics. Published December 8, 2025.  Accessed January 13, 2026. 

https://amphista.com/amphista-therapeutics-presents-new-preclinical-data-showing-the-potential-of-its-brd9-targeted-glue-amx-883-to-transform-the-treatment-paradigm-for-acute-myeloid-leukaemia

Booster Therapeutics launches to pioneer new class of proteasome activator medicines for the treatment of a range of complex diseases. Press release. Booster Therapeutics. Published October 10, 2024. Accessed January 13, 2026. 

https://www.boostertx.com/press-releases/booster-therapeutics-launches-to-pioneer-new-class-of-proteasome-activator-medicines-for-the-treatment-of-a-range-of-complex-diseases

Innovative precision cancer therapies. OncoOne.  Accessed January 13, 2026. 

Next generation proteasome inhibitors for unmet medical needs deployed by an international research & development network. QLi5 Therapeutics. Accessed January 13, 2026. 

QLi5 Therapeutics. QLi5 Therapeutics attracts EUR 10 million in Series A financing. Press release. QLi5 Therapeutics. Published September 7, 2025. Accessed January 13, 2026. 

https://qli5tx.com/qli5-therapeutics-attracts-eur-10-million-in-series-a-financing

Proteasome inhibitors market size & share report, 2025–2034. Global Market Insight. Published March 2025. 

https://www.gminsights.com/industry-analysis/proteasome-inhibitors-market

Willyard C. This scientist found a new trick of the immune system by digging through cellular rubbish. Nature. 2025;648(8094):527. doi:10.1038/d41586-025-03846-3

Proteolysis-targeting chimeras (PROTACs) are gaining momentum as they leverage the ubiquitin-proteasome system to degrade pathogenic proteins, offering potential treatments for previously "undruggable" targets, including challenging cancers. The pharmaceutical industry is heavily investing in proteasome-targeting therapies, with several companies developing and testing new drugs. European biotech firms are also advancing in this field, exploring novel inhibitors and therapeutic applications. The global proteasome inhibitor market is projected to grow significantly, with potential applications extending beyond oncology to autoimmune and inflammatory diseases.

European Frontrunners

Proteasome-targeting therapies may eliminate disease-causing proteins in a broad range of diseases.

PharmTech Europe March 2026

The Impact of New Pharmaceutical and HTA Legislation in Europe

Proteasomes: A Novel Approach to Target the Immune System