www.fdanews.com/articles/177954-chinese-regulators-seek-response-to-modified-registration-rules
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Chinese Regulators Seek Response to Modified Registration Rules
August 12, 2016
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.