Chinese Regulators Seek Response to Modified Registration Rules

The Chinese FDA has made sweeping reforms to the country’s nine-year-old drug registration rules, looking for industry feedback on a range of drug approval related revisions.

The regulator published a total of 147 modifications to drug registration rules, with the goal of increasing approval efficiency and decreasing its backlog of applications, according to a summary by law firm Ropes & Gray. These changes affect everything from data submissions to the renewal process.

Under the revisions, new drug candidates should demonstrate a clinical advantage over existing products to encourage drug manufacturers and discourage remarketing products with minute changes.