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 regulatory strategy, clean eCTD execution, global dossier alignment, IDMP readiness, and strong clinical-technical documentation support. Teams gain a partner that strengthens compliance, accelerates submissions, and improves approval confidence across major markets.

Read more from our experts here: https://resource.ddregpharma.com/insights/regulatory-submission-trends/

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