Canada Priority Expedited Serious, life-threatening or Shortened review time Review review severely debilitating disease or condition for which there is substantial evidence of clinical effectiveness for unmet need OR there is a significant increase in efficacy and/or significant decrease in risk such that the overall benefit/risk profile is improved over existing therapies Canada Notice of Expedited Serious, life-threatening or Filing of an eligible Compliance development, severely debilitating disease or drug submission w/Conditions expedited condition for which there is earlier than review promising evidence of clinical normally possible effectiveness based on the Shortened time to available data that the drug approval and has the potential to meet an market unmet need OR there is a significant increase in efficacy and/or significant decrease in risk such that the overall benefit/risk profile is improved over existing therapies China Priority Expedited Priority review system started Shortened review review review in Feb 2016 with scope time and including: conditional Drug with significant approval can be clinical value granted for For diseases prevention and marketing prior to treatment (including AIDS, TB, the completion of Hepatitis, Rare disease, phase III Malignant tumor, Pediatric confirmatory drug, Diseases with high clinical trial for incidence or unique in elderly new drugs for the people) and can show treatment of significant clinical advantage diseases for which no effective therapeutic methods currently exists and having great significance to meet clinical needs. Egypt Fast-track Expedited Drugs addressing an unmet The time frame of procedure review medical need in Egypt, Drugs fast track with an orphan drug registration is desinations, Drugs for which 18 months, instead no similar products (or of of 24 months in same class or same clinical the normal value) are marketed in Egypt. process.
Canada Priority Review Expedited review Serious, life-threatening or severely debilitating disease or condition for which there is substantial evidence of clinical effectiveness for unmet need OR there is a significant increase in efficacy and/or significant decrease in risk such that the overall benefit/risk profile is improved over existing therapies Shortened review time Canada Notice of Compliance w/Conditions Expedited development, expedited review Serious, life-threatening or severely debilitating disease or condition for which there is promising evidence of clinical effectiveness based on the available data that the drug has the potential to meet an unmet need OR there is a significant increase in efficacy and/or significant decrease in risk such that the overall benefit/risk profile is improved over existing therapies Filing of an eligible drug submission earlier than normally possible Shortened time to approval and market China Priority review Expedited review Priority review system started in Feb 2016 with scope including: Drug with significant clinical value For diseases prevention and treatment (including AIDS, TB, Hepatitis, Rare disease, Malignant tumor, Pediatric drug, Diseases with high incidence or unique in elderly people) and can show significant clinical advantage Shortened review time and conditional approval can be granted for marketing prior to the completion of phase III confirmatory clinical trial for new drugs for the treatment of diseases for which no effective therapeutic methods currently exists and having great significance to meet clinical needs. Egypt Fast-track procedure Expedited review Drugs addressing an unmet medical need in Egypt, Drugs with an orphan drug desinations, Drugs for which no similar products (or of same class or same clinical value) are marketed in Egypt. The time frame of fast track registration is months, instead of 24 months in the normal process. 18
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