Article
Driving innovation, improving access, and the potential for AI: DIA Europe takeaways
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Lidia Lopez
DIA Europe puts the focus on bolstering innovation and improving patient access in Europe and finding ways to streamline regulatory processes
DIA Europe 2026 brought together stakeholders from across the life sciences community to explore issues that are top of mind for industry – from bolstering innovation in Europe to improving patient access to streamlining processes and supporting regulatory rigor, including through the adoption of digital technologies.
The opening session – entitled “A Vision for Europe - Europe as Global Leader of Healthcare and Life Sciences Innovation” – included a forum from the European Commission, regulatory authorities, health technology assessment (HTA) agencies, and industry to discuss how Europe can remain an attractive hub for innovation.
Rainer Becker of the European Commission stressed the importance of a regulatory framework that is modern, flexible, agile and supportive of innovation, accelerating access to medicines for patients in Europe.
The opening session – entitled “A Vision for Europe - Europe as Global Leader of Healthcare and Life Sciences Innovation” – included a forum from the European Commission, regulatory authorities, health technology assessment (HTA) agencies, and industry to discuss how Europe can remain an attractive hub for innovation.
Rainer Becker of the European Commission stressed the importance of a regulatory framework that is modern, flexible, agile and supportive of innovation, accelerating access to medicines for patients in Europe.
Key legislative frameworks include the EU pharmaceutical legislation, which was agreed to in December 20251, and the EU Biotech Act2, which seeks to address regulatory issues that are hindering EU competitiveness.
There was also discussion on how European regulatory processes can delay access to medicines compared with other markets, such as Japan. A speaker from a patient advocacy organization said that innovative medicines arrive too late or not at all to patients depending on where in Europe they live due to discrepancies among national health systems. He also pointed out the need to involve patients early to influence decisions.
The EMA representative, Emer Cooke, said positive steps are being taken to bring innovative medicines to the market faster, although that doesn’t mean deregulation. At a legislative level, the EU Biotech Act is looking at ways to streamline regulatory and legal layers that can slow innovation. Other ways regulators are seeking to speed up innovation is the use of a regulatory sandbox to test ways to support innovative medicines that can’t be developed under current rules.3
There was also discussion on how European regulatory processes can delay access to medicines compared with other markets, such as Japan. A speaker from a patient advocacy organization said that innovative medicines arrive too late or not at all to patients depending on where in Europe they live due to discrepancies among national health systems. He also pointed out the need to involve patients early to influence decisions.
The EMA representative, Emer Cooke, said positive steps are being taken to bring innovative medicines to the market faster, although that doesn’t mean deregulation. At a legislative level, the EU Biotech Act is looking at ways to streamline regulatory and legal layers that can slow innovation. Other ways regulators are seeking to speed up innovation is the use of a regulatory sandbox to test ways to support innovative medicines that can’t be developed under current rules.3
Sharing data, expanding global access
Another key topic of discussion at the conference was enabling better data and information sharing and collaboration to streamline the assessment process and ultimately access to medicines.
There was also discussion about how to improve global clinical trials to enable patients in all markets to gain access to innovative medicines. During a session on the third day, entitled “Navigating the Global Clinical Trials Landscape - Learning Across Regions”, Dr. Vaseeharan Sathiyamoorthy from the World Health Organization (WHO), shared steps for improving access to innovative medicines. These include:
There was also discussion about how to improve global clinical trials to enable patients in all markets to gain access to innovative medicines. During a session on the third day, entitled “Navigating the Global Clinical Trials Landscape - Learning Across Regions”, Dr. Vaseeharan Sathiyamoorthy from the World Health Organization (WHO), shared steps for improving access to innovative medicines. These include:
Patient involvement and community engagement – how involving patients can help shape clinical trials and access to medicine
Inclusion of underrepresented populations in clinical trials – for example, pregnant women and breastfeeding mothers, and finding ways to address this complex issue
Adoption of innovative designs and digital technology – an issue for all countries, particularly those that lack the necessary infrastructure
Accelerated access to training of assessors – providing support from mature agencies so more countries can contribute to the assessment of clinical trials
Speakers emphasized that, depending on where a patient lives, not only within countries but even regions within those countries, access to medicines can be challenging.
In other sessions, speakers from regulatory authorities emphasized the benefits of available pathways for reliance review, collaborative assessment, and joint decision-making across different regions to support earlier access to medicines.
Reliance procedures allow countries whose health authorities have scarce resources to use assessments carried out by other trusted health authorities such as the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA). For example, a representative from the Saudi FDA noted that reliance allowed them to have their assessors review factors that are of specific relevance to their population and rely on the technical reviews carried out by other trusted health authorities. Reliance procedures are leveraged by several developed as well as developing health authorities, including the UK, which implemented the new International Recognition Procedure (IRP) in 20244, and Australia’s Therapeutic Goods Administration (TGA), which uses the Comparable Overseas Bodies process to evaluate applications through an abridged process.5
In other sessions, speakers from regulatory authorities emphasized the benefits of available pathways for reliance review, collaborative assessment, and joint decision-making across different regions to support earlier access to medicines.
Reliance procedures allow countries whose health authorities have scarce resources to use assessments carried out by other trusted health authorities such as the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA). For example, a representative from the Saudi FDA noted that reliance allowed them to have their assessors review factors that are of specific relevance to their population and rely on the technical reviews carried out by other trusted health authorities. Reliance procedures are leveraged by several developed as well as developing health authorities, including the UK, which implemented the new International Recognition Procedure (IRP) in 20244, and Australia’s Therapeutic Goods Administration (TGA), which uses the Comparable Overseas Bodies process to evaluate applications through an abridged process.5
AI everywhere, but details remain sparse
One of the most talked about topics at the conference was artificial intelligence (AI) and how it can support medicines development. Regulators and industry representatives shared their view on how to leverage AI in all stages of product development and post-approval life cycle. However, there were few examples of how AI was being used in practice.
Both regulators and industry professionals raised concerns about AI not allowing users to control the decision-making process or to understand how the tool reaches a conclusion. The inability to validate each decision point was raised as a reason many are hesitant to fully develop and adopt AI.
Another concern that has been raised is leakage of proprietary information and patient data; however, the risk depends on the context in which AI is used and how access to data is controlled. For example, most companies now prevent use of tools such as ChatGPT and Gemini and instead have their own, more controlled, AI environment.
Both regulators and industry professionals raised concerns about AI not allowing users to control the decision-making process or to understand how the tool reaches a conclusion. The inability to validate each decision point was raised as a reason many are hesitant to fully develop and adopt AI.
Another concern that has been raised is leakage of proprietary information and patient data; however, the risk depends on the context in which AI is used and how access to data is controlled. For example, most companies now prevent use of tools such as ChatGPT and Gemini and instead have their own, more controlled, AI environment.
Nevertheless, AI or automation remains a highly talked about topic as the industry and regulators look for ways to reduce workload and speed up access to medicines. Different national competent authorities are developing guidelines and reflection papers on this topic. For example, EMA and FDA have released guiding principles of good AI practice in drug development.6
A representative from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) discussed steps the agency is taking with AI adoption. The MHRA released updates to its GCP Inspection Dossier Template to include formal requirements for using AI and machine learning throughout the clinical trial lifecycle.7 Also at the conference, a representative from the Swedish Medical Products Agency showcased the use of digital technology to review pharmaceutical dossiers.
The industry and regulators both embrace risk-based and risk-mitigation AI/ML approaches to identify issues such as bias, data privacy, data quality and model robustness, generalizability, AI safety and hallucinations, explainability, among others. All speakers also emphasized the importance of having humans in the loop to review any AI-driven processes.
Conclusion: Collaboration and engagement
Beyond the headline discussions, tracks at the conference explored new and recently implemented regulations, such as ANVISA’s new regulation on clinical trials in Brazil.
Generally, throughout the conference it was good to witness patient groups being represented at all sessions, which indicates growing recognition that patients are key to shaping clinical trials and access to medicines.
The emphasis on collaboration and information sharing, and on seeking ways to improve processes, including with the use of digital technologies, shows a commitment to seeking solutions for the barriers that continue to impact innovation and patient access.
Generally, throughout the conference it was good to witness patient groups being represented at all sessions, which indicates growing recognition that patients are key to shaping clinical trials and access to medicines.
The emphasis on collaboration and information sharing, and on seeking ways to improve processes, including with the use of digital technologies, shows a commitment to seeking solutions for the barriers that continue to impact innovation and patient access.
*Sources listed below
About the author:
Lidia Lopez is Associate Director, Regulatory Affairs, Regulatory Strategy and Procedure Management, at Cencora. Lidia holds a PhD in Molecular Biology and has over 10 years of experience in Regulatory Affairs, supporting the development, registration, and lifecycle management of pharmaceutical products across different regions.
Disclaimer:
The information provided in this article does not constitute legal advice. Cencora, Inc., strongly encourages readers to review available information related to the topics discussed and to rely on their own experience and expertise in making decisions related thereto.
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Sources
1. Commission welcomes political agreement on major reform of EU pharmaceutical rules, European Commission. https://ec.europa.eu/commission/presscorner/detail/en/ip_25_3015
2. EU Biotech Act | Dual-Use and Security Concerns, European Commission. https://www.eu-biotech-act.com/
3. EMA welcomes political agreement on new EU pharmaceutical legislation, EMA, December 2025. https://www.ema.europa.eu/en/news/ema-welcomes-political-agreement-new-eu-pharmaceutical-legislation
4. International Reliance Procedure, MHRA. https://www.gov.uk/government/publications/international-recognition-procedure/international-recognition-procedure
5. Using the Comparable Overseas Bodies process for registered complementary medicines, assessed listed medicines and substances in listed medicines, TGA. https://www.tga.gov.au/resources/guidance/using-comparable-overseas-bodies-process-registered-complementary-medicines-assessed-listed-medicines-and-substances-listed-medicines#:~:text=The%20Therapeutic%20Goods%20Administration%20(TGA)%20uses%20evaluation,Allow%20applications%20to%20have%20shorter%20evaluation%20timeframes
6. Guiding Principles of Good AI Practice in Drug Development, FDA. https://www.fda.gov/about-fda/artificial-intelligence-drug-development/guiding-principles-good-ai-practice-drug-development
7. GCP Inspection Dossier Template, MHRA.
