2025 is the year of regulatory guidance to examine the usefulness of AI models in decision-making about the drug safety and effectiveness.
These guidelines also emphasize transparency, data quality, and continuous monitoring.
From February 2, 2025, pharmaceutical companies in the European Union (EU) region must comply with AI literacy requirements and avoid AI practices that are prohibited under Article 514.
By August 2, 2025, obligations for general-purpose AI models will take effect, which might impact AI-driven drug development and regulatory submissions.
The FDA has also published a draft regulatory guidance on the matter.
Pharmaceutical audits now include:
- Data integrity checks
- Digital batch records
- System validation
At Audit Associates Pharma we audit with a forward-looking lens to ensure real-world compliance.
Email info@aap.ie for more information!
