Regulatory Trends That Will Shape 2026 Submissions
The regulatory trends below show how 2026 will influence submission planning across pharmaceuticals , biologics , combination products, medical devices , and advanced therapies. 1. Global Alignment on Benefit–Risk Frameworks 2. Expansion of IDMP-Based Data Exchange 3. Greater Use of AI-Augmented Dossier Screening by Regulators 4. Rising Expectations for Real-World Evidence (RWE) 5. Stronger Governance for Decentralised and Hybrid Clinical Trials 6. Expansion of Sustainability-Linked Compliance Requirements 7. New Convergence in GMP and GDP Expectations 8. Growth in Interoperable e-Labeling and Digital Information Delivery 9. Strengthening of Post-Market Performance Reporting 10. Increased Scrutiny of Manufacturing Process Variability 11. Harsher Non-Compliance Penalties for Data Integrity Breaches 12. Broader Oversight for AI-Enabled Medical Technologies DDReg Capability DDReg guides companies through rapidly evolving 2026 requirements with precise r...