treatment of a serious (life threatening) condition, demonstrates the potential to address unmet medical needs, or as a breakthrough S. Korea Priority Expedited New products for serious, life Shortened review time Review review threatening or rare disease with an unmet need or with no alternative therapy among locally developed NME, drug S. Korea Rolling Expedited New biotech like Cell therapy Expedited submission Submission submissions and Gene therapy and biosimilars S. Korea Conditional Expedited Oncology products, orphan Ability to base studies Approval development drugs, cell therapy for on phase 2 studies with w/Phase 2 or irreversible surrogate endpoint Results3 disease that use surrogate endpoints S. Korea Full Approval Expedited Unmet need and less than Ability to base studies w/Phase 2 development 2000 cases in a year on phase 2 studies with Results surrogate endpoint Saudi Arabia Priority Expedited Medicines for serious or life A reduction in the drug review review threatening conditions, approval timeline from medicines which demonstrate months to 12 the potential to address months. unmet medical needs, medicines that fall under the Saudi FDA exempted list. Singapore Priority Expedited Serious life-threatening Shortened review time Review4 review condition AND potential to address local unmet medical needs AND a significant improvement compared to available marketed products Switzerland Fast-track Expedited Promising therapy for a Shortened review time review severe, debilitating or (from 330 days to 140 disease AND days) unmet need And a high therapeutic benefit is expected from using this new medicinal product. Taiwan Priority Expedited New molecular entity for Shortened review time Review review serious disease AND unmet to 240 days medical needs AND delivers major advance Taiwan Accelerate Expedited New molecular entity and Approval may be Approval development Unmet medical need AND granted at an earlier delivers major advance (or time point, subject to with ODD approved by a A10 specific obligations for country, or difficult to confirmatory studies manufacture or import) AND uses a surrogate endpoint
treatment of a serious (life threatening) condition, demonstrates the potential to address unmet medical needs, or as a breakthrough S. Korea Priority Review Expedited review New products for serious, life threatening or rare disease with an unmet need or with no alternative therapy among locally developed NME, drug Shortened review time S. Korea Rolling Submission Expedited submissions New biotech like Cell therapy and Gene therapy and biosimilars Expedited submission S. Korea Conditional Approval w/Phase 2 Results3 Expedited development Oncology products, orphan drugs, cell therapy for or irreversible disease that use surrogate endpoints Ability to base studies on phase 2 studies with surrogate endpoint S. Korea Full Approval w/Phase 2 Results Expedited development Unmet need and less than 2000 cases in a year Ability to base studies on phase 2 studies with surrogate endpoint Saudi Arabia Priority review Expedited review Medicines for serious or life threatening conditions, medicines which demonstrate the potential to address unmet medical needs, medicines that fall under the Saudi FDA exempted list. A reduction in the drug approval timeline from months to 12 months. Singapore Priority Review4 Expedited review Serious life-threatening condition AND potential to address local unmet medical needs AND a significant improvement compared to available marketed products Shortened review time Switzerland Fast-track Expedited review Promising therapy for a severe, debilitating or disease AND unmet need And a high therapeutic benefit is expected from using this new medicinal product. Shortened review time (from 330 days to 140 days) Taiwan Priority Review Expedited review New molecular entity for serious disease AND unmet medical needs AND delivers major advance Shortened review time to 240 days Taiwan Accelerate Approval Expedited development New molecular entity and Unmet medical need AND delivers major advance (or with ODD approved by a A10 country, or difficult to manufacture or import) AND uses a surrogate endpoint Approval may be granted at an earlier time point, subject to specific obligations for confirmatory studies
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