AI regulation tsunami hits pharma: FDA draft guidance and EU AI Act demand new compliance strategies
As regulatory authorities roll out strict AI oversight frameworks, pharma companies face mounting pressure to embed transparency, validation and bias mitigation (Issue #335; 1,150 words; 5.5 minutes)
Good morning, and welcome to the NPC Healthbiz Weekly e-newsletter from the National Pharmaceutical Congress and Chronicle Companies.
Artificial intelligence (AI) is transforming every aspect of the pharmaceutical industry. In January 2025, the U.S. FDA issued a draft guidance outlining a risk-based approach for evaluating AI models used in regulatory decision-making for drugs and biologics. This guidance emphasizes transparency, model validation, and robust documentation to ensure that AI-generated data supporting regulatory submissions is credible and reliable.
The website Drug Target Review reports that recent advances in AI, particularly in generative models and predictive analytics, are enabling pharmaceutical companies to accelerate drug discovery and optimize clinical trials. For example, the publication notes that AI-driven digital twin models are being used to simulate patient outcomes, allowing for more efficient trial designs and potentially reducing the number of participants needed without compromising data quality. These innovations shorten development timelines and reduce costs, but also introduce new complexities regarding data integrity, algorithmic bias, and reproducibility.
Regulatory authorities are increasingly focusing on the challenges posed by AI, including the need for explainability, accountability, and mitigation of bias. The U.S. FDA’s recent draft guidance requires sponsors to provide detailed descriptions of AI models, including intended use, data sources, training and validation procedures, and performance metrics.
In Europe, the European Union AI Act introduced a risk‑based classification of AI systems in August 2024. High‑risk applications, such as those in drug development, face strict validation, transparency, and monitoring requirements. The European Medicines Agency (EMA) is also shaping a structured, compliance‑heavy approach. New York-based law firm White & Castle notes that the EMA’s Data Steering Group released a work plan for 2025-2028 outlining six distinct AI workstreams, ranging from signal detection and data quality to regulatory guidance and horizon scanning. The plan includes phased rollouts of methodological frameworks, stakeholder engagement initiatives, and observatory reports, with initial deliverables expected by the fourth quarter of 2025.
In Canada, the regulatory landscape is evolving in parallel with global trends. Canada’s Drug Agency published a new position statement in 2025 on the use of AI methods in health technology assessment, emphasizing the importance of transparency, trustworthiness, and ethics in AI-informed evidence generation. The Artificial Intelligence and Data Act (AIDA) was set to introduce requirements for high-impact AI systems, including those in healthcare, focusing on minimizing risks related to bias, discrimination, and public harm. However, the law firm Baker McKenzie reports that the bill died on the order paper when Parliament was prorogued in Jan 2025, and has not been reintroduced. Despite AIDA’s demise, the Canadian government will have to seek to pass legislation regulating artificial intelligence eventually.
Pharmaceutical companies are responding by embedding AI literacy and governance across operations. Business Insider reports that big pharma companies such as Johnson & Johnson, Merck, and Eli Lilly have launched large-scale AI training programs, training thousands of employees in skills in prompt engineering, validation frameworks, and data privacy compliance. AI and data engineering company Xenoss notes that companies in the life sciences industry are expected to build explainability and compliance readiness into their systems in anticipation of these regulations.
Additional reading:
THIS WEEK 07/08/25
Quebec implemented the public reimbursement of Novartis’ lutetium (177Lu) vipivotide tetraxetan injection (Pluvicto) for eligible patients with PSMA-positive metastatic castration-resistant prostate cancer.
Health Canada approved Apotex’s aflibercept (Aflivu), a biosimilar to Eylea, for the treatment of neovascular (wet) age-related macular degeneration, macular edema secondary to central or branch retinal vein occlusion, treatment of diabetic macular edema, and treatment of myopic choroidal neovascularization.
The U.S. FDA granted accelerated approval of Regeneron’s linvoseltamab-gcpt (Lynozyfic) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti‑CD38 monoclonal antibody.
Gilead Sciences announced the U.S. FDA approved lenacapavir (Yeztugo), an injectable HIV-1 capsid inhibitor, as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV..
Call for nominations for the Canadian Healthcare Marketing Hall of Fame
Nominations are now open for the 2025 Canadian Healthcare Marketing Hall of Fame, which honours individuals who have made a lasting contribution to the field of healthcare marketing in Canada. Established to recognize professionals whose work exemplifies leadership, integrity, and impact, the Hall of Fame highlights those who have demonstrated extraordinary commitment to the humane principles inherent in our profession and made a lasting impact on others.
Inductees will be honoured at the 23rd Annual Canadian Healthcare Marketing Hall of Fame Ceremony, held during the 19th National Pharmaceutical Congress on November 4, 2025.
To view past recipients and submit a nomination, visit the Canadian Healthcare Marketing Hall of Fame.
This is an opportunity to recognize excellence in healthcare marketing and celebrate those who have shaped the profession.
NOW, LISTEN UP: HERE’S BETTINA HAMELIN OF INNOVATIVE MEDICINES CANADA
In Season 14 of the NPC Podcast, Dr. Bettina Hamelin, President of Innovative Medicines Canada, offers insights into adopting innovative technologies, the domestic pharmaceutical supply chain, and the exclusion of medicines as retaliatory measures for tariffs. Hear her in conversation with podcast hosts Mitch Shannon, Jim Shea, and Mark McElwain.
HEALTHBIZ REWIND
This feature of NPC Healthbiz Weekly looks back at some of the most insightful moments from previous NPC Podcast episodes. You can listen to the podcast here.
Lee Ferreira
General Manager
Ferring Pharmaceuticals
Toronto
Season 01, episode 04
Listen to this episode here
What are the implications of new technological approaches on your team’s capacity, company efficiency, and overall impact? (This episode was recorded in July of 2020)
If we become more effective and efficient in how we engage, it could mean less downtime waiting in offices or with travel since we can create interactions in a more streamlined way. I see this evolving. We might need to develop new capabilities and competencies in our people, but it could also allow us to reallocate funds from traditional roles and reinvest them in aspects of healthcare that are more focused on patient needs. This would help patients gain better access to medication. I believe we can reinvest those dollars into areas that are more meaningful to the care, health, and well-being of patients.
NEXT WEEK
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