2025-01-12-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）_12页_3mb

2025 Safety and Regulatory Compliance Trends and Predictions Summary

Introduction

The drug safety and regulatory compliance landscape continues to evolve, driven by complex therapies, global demand, and technological advancements like AI. Enhanced technology integration aims to improve patient-centric solutions and manage increasing inquiries. Innovations focus on reducing costs, improving accuracy, and streamlining operations.

Surprises in 2024

Expert observations included: rapid adoption of AI across pharmaceutical services; increased outsourcing of niche PV services (e.g., local literature surveillance and periodic reporting) due to cost pressures; post-pandemic shifts in MI behavior, with self-service digital channels becoming more prominent; and regulatory initiatives promoting clinical trial innovations.

Role of AI in 2025

AI is expected to enhance productivity and customer engagement in MI by handling low-complexity inquiries, allowing human teams to focus on higher-level tasks. It will support automation in file authoring, real-time portfolio status updates for post-marketing variations, and improved signal detection in PV. Regulatory bodies may issue guidelines emphasizing a risk-based approach, transparency, and explainability for AI use in drug development.

Regulating Harmonization and Approvals

Regulatory bodies are moving toward harmonized submission processes through cloud-based technologies and widespread ECTD adoption, facilitating real-time information exchange. This could accelerate approvals in emerging markets by simplifying data submission and global alignment. Emerging markets may see faster approvals due to reduced barriers and standardized protocols.

Adapting Operations and Local Compliance

Pharmaceutical companies must rely on local Qualified Persons for Pharmacovigilance (QPPV) to navigate evolving local regulatory requirements while integrating global best practices. Outsourcing to competent vendors is recommended, as they combine human expertise with integrated technology (e.g., AI for case processing) to ensure ongoing compliance and anticipate regulatory changes.

Cross-Team Collaborations and MI Management

Technological innovations like omnichannel systems support collaborative input, review, and approval across stakeholders. AI-driven platforms will enhance MI by offering personalized engagement options, but companies face challenges in ensuring compliance across digital channels, including risk management for data privacy and controlled AI-generated responses.

Post-Approval Lifecycle Management

AI and data analytics will optimize post-approval activities, such as registration renewals and label updates, by automating processes, reducing timelines, and minimizing human errors. This includes comparing and implementing labeling changes based on regulatory guidance, improving efficiency and safety outcomes.

Regulatory Guidelines on AI

Regulators, including the FDA, may introduce stricter guidelines in 2025, focusing on AI's use in drug development with a risk-based approach. These guidelines will address transparency, explainability, and patient safety, potentially influencing early-stage innovation and real-world data applications.

Outsourcing Trends

Partnering with vendors that provide integrated AI and human expertise will grow, enabling better management of regulatory intelligence and operational burdens. These vendors are expected to deliver efficient, scalable solutions for PV and MI, adapting quickly to regulatory updates.

• IQVIA's Contribution: As a global provider of clinical research and healthcare intelligence, IQVIA emphasizes its role in facilitating these trends through connected intelligence and a network of experienced professionals.