Turkey Priority Expedited Innovative products A reduction in the drug evaluation review addressing an unmet medical review timeline and the need possibility for parallel Other products can be GMP inspections. designated as highly prioritized and prioritized according to their impact on public finance and production status. USA Breakthrough Increased HA Serious condition AND when All Fast-track Therapy collaboration early clinical data show a benefits, PLUS: Designation to support substantial improvement on a Intensive guidance (BTD) expedited clinically significant endpoint on efficient drug development (s) over existing therapy development- + eligibility for timely and expedited interactive, submission including potential and review for abbreviated or condensed development, i.e., potential for shorter, smaller trials Meetings w/sponsors throughout development Organizational commitment Potential for Expedited review (even faster than ‘normal’ expedited review in USA) USA Fast-Track Increased HA Serious condition AND Actions to expedite designation collaboration nonclinical or clinical data development and to support demonstrate the potential to review, including expedited address unmet medical need more frequent development OR a drug designated for a meetings and + eligibility for qualified infectious disease written expedited correspondence submission and eligibility to submit data as it becomes available (rolling review) USA Accelerated Expedited Serious condition AND a Approval based on Approval Development meaningful advantage over surrogate or other therapies AND surrogate intermediate endpoint likely to predict endpoint, allowing benefit or on a clinical for shorter endpoint that can be development time measured earlier than an and earlier effect on IMM or other clinical submission/ benefit approval of MAA,
Turkey Priority evaluation Expedited review Innovative products addressing an unmet medical need Other products can be designated as highly prioritized and prioritized according to their impact on public finance and production status. A reduction in the drug review timeline and the possibility for parallel GMP inspections. USA Breakthrough Therapy Designation (BTD) Increased HA collaboration to support expedited development + eligibility for expedited submission and review Serious condition AND when early clinical data show a substantial improvement on a clinically significant endpoint (s) over existing therapy All Fast-track benefits, PLUS: Intensive guidance on efficient drug development- timely and interactive, including potential for abbreviated or condensed development, i.e., potential for shorter, smaller trials Meetings w/sponsors throughout development Organizational commitment Potential for Expedited review (even faster than ‘normal’ expedited review in USA) USA Fast-Track designation Increased HA collaboration to support expedited development + eligibility for expedited submission Serious condition AND nonclinical or clinical data demonstrate the potential to address unmet medical need OR a drug designated for a qualified infectious disease Actions to expedite development and review, including more frequent meetings and written correspondence and eligibility to submit data as it becomes available (rolling review) USA Accelerated Approval Expedited Development Serious condition AND a meaningful advantage over other therapies AND surrogate endpoint likely to predict benefit or on a clinical endpoint that can be measured earlier than an effect on IMM or other clinical benefit Approval based on surrogate or intermediate endpoint, allowing for shorter development time and earlier submission/ approval of MAA,
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