Regulating Biotech at Scale

You are advising a health regulator redesigning the approval framework for biologic medicines such as vaccines, blood products, and other complex therapies. Explain how regulation can be simplified while preserving safety, traceability, and public trust. What kinds of rules should be risk-based, what should remain strict, and where can digital documentation or harmonized standards reduce friction? Include examples of how a better regulatory system can affect domestic manufacturing, regional supply chains, and emergency readiness. Finish with a practical checklist for modernizing oversight of biologics.