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  • Regulatory NewsRegulatory News

    Japan Edges out FDA for Fastest Approvals

    In 2014, Japan's regulator, the Pharmaceuticals and Medical Devices Agency (PMDA) edged out the US Food and Drug Administration (FDA) as the world's fastest regulator, with a median approval time of 306 days for new active substances (NASs). New Drug Approvals in ICH Countries A new report by the Centre for Innovation in Regulatory Science (CIRS), New Drug Approvals in ICH Countries 2005-2014 , examines NAS approvals in the US, EU and Japan. The report finds that FD...
  • Regulatory NewsRegulatory News

    Among Global Drug Regulators, FDA Still the Best, But Others Are Catching up—Fast

    Six of the world's most preeminent regulatory bodies have become increasingly adept at approving new drug products more quickly and consistently, according to a new analysis published by the Centre for Innovation in Regulatory Science (CIRS). Background: Study CIRS' analysis looked at new drug approval decisions made over the past decade by six regulators: The US Food and Drug Administration (FDA) The European Medicines Agency (EMA) Japan's Pharmaceutical and Medica...