艾昆纬-2025年制药和生物技术安全和监管合规趋势及预测（英）-2024_12页_3mb

2025 Pharma Regulatory Compliance Trends

AI and technology are expected to significantly improve efficiency, accuracy, and compliance in regulatory affairs and pharmacovigilance.

In 2025, AI will enhance human interactions in medical information (MI) by handling low-complexity queries, allowing human teams to focus on complex issues and improving customer engagement. Regulators are showing a risk-based approach to AI, focusing on applications closer to patients rather than early-stage drug development.

AI's impact is notable across the drug lifecycle:

• Global regulatory harmonization is advancing via cloud-based systems and eCTD adoption, speeding up submission processes and approvals.
• Local Qualified Persons for Pharmacovigilance (QPPV) will be crucial for ensuring compliance with both global standards and regional requirements by acting as liaison officers.
• For CMC variations, AI can automate data gathering, reduce timelines, and manage costs by streamlining the change control process.
• Technology like machine translation and natural language processing are reducing costs and improving translation and data analysis efficiency in drug development.
• Technological innovations including omnichannel systems, AI, and collaborative platforms are improving cross-functional teamwork for regulatory intelligence and MI management, though compliance across diverse platforms remains a challenge.
• Post-approval, AI will support registration renewals and label updates by accelerating analysis and reducing errors. Regulators appear to be developing guidelines around AI transparency and explainability.

Third-party vendors are increasingly essential for regulatory burden management, providing combined human and technological expertise in areas like case processing and signal detection. Key emerging themes include leveraging AI strategically based on risk levels, maintaining strict data privacy and security, and fostering better patient engagement.