Times are changing, generative AI in pharma no longer gets a free pass.
First of all, AI now is governed. You can't just install any random AI software module and hope for the best: you'll be promptly shot down by IT governance commitees. Oops!
Secondly, when you use AI, better keep your source data available!
Regulatory authorities around the world have set limits on how AI use is allowed in drug submissions. Please pay attention.
EU/USA: 1/2026 EMA/FDA: Guiding principles of good AI practice in drug development
Note items 6, 8, 9: data provenance, QC, model performance monitoring. Exactly what Saber Informatics has been saying for years. Gotta show where your data came from in the first place! Please show the sources.
China mainland: 3/2026 Opinions of the State Drug Administration on the Implementation of "Artificial Intelligence + Drug Supervision"
"加强训练数据、微调数据和知识库等数据资源管理，确保来源合法、内容准确、使用合规、全程可追溯" "Strengthen the management of data resources including training data, fine-tuning data, and knowledge bases, ensuring legitimate sources, accurate content, compliant use, and full-process traceability."
Even worse for those of us who thought "ah, no need to log". Yes, need to log. Otherwise be non-compliant. Cha bu duo isn't anymore.
Call us at Saber Informatics to restore your data provenance. We have the tools and we have the knowledge to help you now!
