Shanghai municipal Food and Drug Safety Committee issued its 15th Five-Year plan
to ensure drug safety and promote high-quality pharmaceutical development,
calling for targeted supervision of priority fields and products. It mandates
establishment of accountability and risk‑sharing mechanisms for contract
manufacturing and enforcement of quality‑and‑safety responsibilities defined in
contract manufacturing agreements. The plan orders intensified on-site
inspections at vaccine producers and full-coverage targeted supervision for
vaccines, blood products, advanced therapy drugs, sterile pharmaceuticals,
special-category medicines and products with segmented production processes,
with emphasis on data reliability, sterility assurance, deviation control and
change management. It also tightens oversight of implantable and sterile medical
devices and devices selected via centralized procurement, requires
one-product/one-policy regulatory plans for innovative devices, and steps up
checks on procurement of critical raw materials, finished‑product testing and
release. Separately, Shanghai will launch a production quality-management
upgrade for cosmetics manufacturers, prioritizing special-use cosmetics and
products using new raw materials and strengthening raw‑material controls.
