ARTICLE SUMMARY:
In this week’s Pathways Picks: China approves new clinical trial oversight rules and eyes health system reforms; US industry groups will get their day in court against the Library of Congress; digital therapeutics accreditation planned; study shows women are still under-enrolled in device trials; lawmakers seek input for a new Cures 2.0 innovation bill; and more on digital health, health technology assessments, and adverse event reporting.
China Picks
Clinical trial and health system reforms (links in Simplified Chinese):
Clinical trials oversight upgrade. New rules for supervising institutions that perform medical device clinical trials in China were approved by the National Medical Products Administration June 7. The measures, which had been issued in draft form for public comment in March and will take effect in October, detail procedures for conducting inspections of clinical trial sites and appropriate enforcement measures including suspending new device trials at sites that aren’t complying with requirements. The rules are intended to better standardize trial conduct, ensure trial results are accurate, complete, and traceable, and protect the rights of trial subjects, NMPA says. The agency says it plans to publish a document outlining the “key points” of the new requirements in conjunction with the October 1 effective date.
