White Paper

2025 Safety And Regulatory Compliance Trends And Predictions For Pharma And Biotech

By Patrick Brady, PharmD, Sabika Rizvi, Ph.D., Marcela Miño, Ana Pedro Jesuíno, and Simon Johns

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The pharmaceutical and biotech industries face a rapidly evolving regulatory landscape as they integrate artificial intelligence (AI) and advanced technologies into safety, compliance, and lifecycle management. Here we explore key trends and predictions for 2025, highlighting the transformative role of AI in streamlining regulatory processes, post-approval activities, and patient-centric solutions. AI's application in areas like pharmacovigilance (PV), chemistry, manufacturing, and controls (CMC) variations, and Medical Information (MI) is enabling automation, reducing human error, and accelerating global regulatory submissions.

With regulators increasingly embracing a risk-based approach, the industry anticipates stricter guidelines focused on AI transparency and explainability. Additionally, global harmonization efforts, such as the adoption of electronic submissions and cloud-based systems, are set to enhance efficiency and foster approvals in emerging markets. While challenges persist in maintaining compliance across AI-driven platforms, innovative tools and cross-functional collaborations offer opportunities for enhanced data accuracy and operational efficiency. As regulatory agencies and industry leaders adapt to these advancements, partnerships with competent technology providers are crucial for navigating complexities and driving innovation in drug safety and regulatory compliance.

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