The Impact of New Pharmaceutical and HTA Legislation in Europe

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.1 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).2-5 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).6-8

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

•improve patient access to medicines.1

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.1

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 (Figure 1).

What is the New EU HTA Regulation?

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.10

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.11

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. 12

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.13 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.14

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.

References

1. Reform of the EU pharmaceutical legislation. European Medicines Agency; 2025. Accessed 19 March 2026. ema.europa.eu
2. Regulation (EC) No 726/2004. European Medicines Agency; 2022. Accessed 19 March 2026.ema.europa.eu
3. Directive 2001/83/EC. European Medicines Agency; 2025. Accessed 19 March 2026.ema.europa.eu
4. Regulation (EC) No 1901/2006. European Medicines Agency; 2019. Accessed 19 March 2026.ema.europa.eu
5. Regulation (EC) No 141/2000. European Medicines Agency; 2025. Accessed 19 March 2026.ema.europa.eu
6. Regulation (EC) No 1394/2007. European Medicines Agency; 2019. Accessed 19 March 2026.ema.europa.eu
7. Regulation (EU) No 536/2014. European Medicines Agency; 2022. Accessed 19 March 2026.ema.europa.eu
8. Regulation (EU) 2022/123. European Medicines Agency; 2022. Accessed 19 March 2026.ema.europa.eu
9. Regulation (EU) 2021/2282. European Medicines Agency; 2021. Accessed19 March 2026.ema.europa.eu
10. Johns A, Andrade A, Johal S, Ryan J. EU joint clinical assessment: a framework for optimising use with cost-effectiveness decision-making. J Mark Access Health Policy. 2025;13(4):52.
11. 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.
12. Regulation (EU) 2025/2086. European Medicines Agency; 2025. Accessed19 March 2026.ema.europa.eu
13. 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
14. 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_/.

About the Author

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

Article Details

PharmTech Europe
Vol. 38, No. 1
March 2026
Pages: 4–5

Citation

When referring to this article, please cite it as Barton C. The impact of new pharmaceutical and HTA legislation in Europe. PharmTech Europe 2026 38 (1).