FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Chinese Regulators Seek Response to Modified Registration Rules

Aug. 15, 2016
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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.

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