Shanghai Sets 15th Five-Year Drug Safety Plan, Tightens Oversight of Vaccines and Advanced Therapies

The signal here is regulatory infrastructure rather than any single product: stationing inspectors inside vaccine plants and extending full-coverage supervision to advanced therapy drugs and blood products moves Shanghai toward continuous, process-level oversight instead of periodic checks. That raises the compliance bar for manufacturers in these categories, particularly on data integrity and sterility assurance, where the plan explicitly tightens risk controls. The open question is whether this prescriptive model stays a Shanghai pilot or becomes a template other regions adopt, and how smaller advanced-therapy developers absorb the added scrutiny.