reference authority. days (150 days for medicines) Ukraine Simplified Abridged review Effective for products A review in 20 working procedure registered in the following days instead of 210. countries: USA, Japan, Switzerland, Canada, EU (in case of centralized procedure only) 1 A significant impact on the registration timelines for NDAs not yet seen in current practice. 2 Any of the following agencies are used as reference authorities: TGA, Health Canada, US FDA, EMA via the centralized procedure, UK MHRA via the national procedure or as the reference member state via the Mutual Recognition Procedure or De-centralized procedure. Appendix 2 – Current overview of countries with different types of expedited registration pathways1 for products addressing unmet medical need Overview last updated: November 2017 Region/Country Pathway Type of Key Criteria for Designation Potential Benefit(s) pathway according to EFPIA suggested naming Australia Priority Expedited Serious condition; and Shortened review time Review review comparison against existing (150 working days therapeutic goods; and major instead of 255) therapeutic advance. Australia Provisional Expedited Promising evidence from early Filing of an eligible Approval development clinical data. drug submission earlier than normally possible Shortened time to approval and market Brazil Priority Expedited Applicable to medicines that Shortened review time review2 review meet certain health, economic and social criteria. Brazil Phase II Expedited Dossiers of synthetic and Earlier submission of submission development biological drugs can be dossiers. (no official submitted with Phase II data name) and Phase III studies initiated. There is no detailed guideline on this pathway and they are applied based on a rationale.
reference authority. days (150 days for medicines) Ukraine Simplified procedure Abridged review Effective for products registered in the following countries: USA, Japan, Switzerland, Canada, EU (in case of centralized procedure only) A review in 20 working days instead of 210. 1 A significant impact on the registration timelines for NDAs not yet seen in current practice. 2 Any of the following agencies are used as reference authorities: TGA, Health Canada, US FDA, EMA via the centralized procedure, UK MHRA via the national procedure or as the reference member state via the Mutual Recognition Procedure or De-centralized procedure. Appendix 2 – Current overview of countries with different types of expedited registration pathways1 for products addressing unmet medical need Overview last updated: November 2017 Region/Country Pathway Type of pathway according to EFPIA suggested naming Key Criteria for Designation Potential Benefit(s) Australia Priority Review Expedited review Serious condition; and comparison against existing therapeutic goods; and major therapeutic advance. Shortened review time (150 working days instead of 255) Australia Provisional Approval Expedited development Promising evidence from early clinical data. Filing of an eligible drug submission earlier than normally possible Shortened time to approval and market Brazil Priority review2 Expedited review Applicable to medicines that meet certain health, economic and social criteria. Shortened review time Brazil Phase II submission (no official name) Expedited development Dossiers of synthetic and biological drugs can be submitted with Phase II data and Phase III studies initiated. There is no detailed guideline on this pathway and they are applied based on a rationale. Earlier submission of dossiers.
white-paper-on-reliance-and-expedited-registration-pathways-in-emerging-markets.docx