As a medical technology, CGT (cell and gene therapy) can conduct IITs (investigator-initiated trials) even before the product is approved for market — it only needs to be filed with the hospital's supervising authority, registered on ChiCTR, and approved by the hospital's ethics committee. This creates a regulatory gap. The "Order 818" policy, which took effect May 1 this year, has tightened oversight of this type trials to some extent. Of course, CGTs also can be as drug to file IND applications to NMPA, and conduct registratory study and approved as drugs. For non-medical-technology drugs, however, IITs still require NMPA market approval first — for example, real-world studies exploring expanded indications. Separately, Hainan's Boao Lecheng pilot zone serves as a testing ground, allowing products already approved overseas but not yet approved by the NMPA to be used in designated pilot hospitals after approvals within the zone, enabling real-world studies to be conducted there.