and/or public health (incl. orphan drugs) Israel Fast-track Expedited • One of the following Gives the procedure review categories should be met: possibilities to o The product is companies to intended for unmet medical register in Israel need. without SRA o The product is part of approval (product a new therapeutic group and has to be significant effectiveness was submitted proven in comparison to the existing alternatives for a simultaneously specific illness. and were o Products that are categorized as categorized with high medical indications with significance in comparison to high medical the existing medical significances in alternatives, such as: life comparison to the extension, organ rescue, existing medical healing of severe illness or alternatives) provides solution to a unique medical situation in Israel that was not resolved appropriately . Japan Priority Expedited Serious disease where there is Shortened review time Review review there is no existing method of (from 12 months to 9 treatment, prophylaxis, or months) diagnosis AND there is therapeutic usefulness with respect to existing treatment from the standpoint of efficacy, safety, and reduction of physical and mental burden on the patient Japan Sakigake Increased HA In addition to Priority Review Prior assessment collaboration criteria, there is novel by PMDA to support mechanism of action for Clinical trial expedited diseases that consultations development demonstrates prominent request notice and expedited effectiveness and developed period will be review and planned for approval in shortened from Japan ahead of the rest of the two months to one world, or at least global month simultaneous submissions Shortened review period from 12 months to 6 months Reexamination period potentially extended (longer market exclusivity). Kuwait Priority Expedited A new drug is considered as a Facilitate and expedite review review priority review designation review when its intended for the
and/or public health (incl. orphan drugs) Israel Fast-track procedure Expedited review • One of the following categories should be met: o The product is intended for unmet medical need. o The product is part of a new therapeutic group and significant effectiveness was proven in comparison to the existing alternatives for a specific illness. o Products that are categorized with high medical significance in comparison to the existing medical alternatives, such as: life extension, organ rescue, healing of severe illness or provides solution to a unique medical situation in Israel that was not resolved appropriately . Gives the possibilities to companies to register in Israel without SRA approval (product has to be submitted simultaneously and were categorized as indications with high medical significances in comparison to the existing medical alternatives) Japan Priority Review Expedited review Serious disease where there is there is no existing method of treatment, prophylaxis, or diagnosis AND there is therapeutic usefulness with respect to existing treatment from the standpoint of efficacy, safety, and reduction of physical and mental burden on the patient Shortened review time (from 12 months to 9 months) Japan Sakigake Increased HA collaboration to support expedited development and expedited review In addition to Priority Review criteria, there is novel mechanism of action for diseases that demonstrates prominent effectiveness and developed and planned for approval in Japan ahead of the rest of the world, or at least global simultaneous submissions Prior assessment by PMDA Clinical trial consultations request notice period will be shortened from two months to one month Shortened review period from 12 months to 6 months Reexamination period potentially extended (longer market exclusivity). Kuwait Priority review Expedited review A new drug is considered as a priority review designation when its intended for the Facilitate and expedite review
white-paper-on-reliance-and-expedited-registration-pathways-in-emerging-markets.docx