approved by SRAs Dominican Republic Simplified procedure Abridged review New chemical entities and new biologics, renewals and post-approval changes. The product must be manufactured and commercialized in the country in which it was approved by the SRA or PAHO Regional Level IV Authorities Review within 3 months after the file is submitted. Ecuador Homologation Procedure1 Verification review Applicable to new registrations previously approved by EMA, FDA, TGA, HC, Japan, South Korea and PAHO Regional Level IV authorities Shorter registration timelines than average (however, no standard registration timelines are provided) Egypt Verification procedure Verification review New chemical entities and new biologics registered by US FDA and EMA Review within 30 days after the file is received Egypt Abridged Procedure Verification review New chemical entities and new biologics registered by US FDA or EMA Review within 60 days after the file is received El Salvador Recognition of registrations Abridged review New registrations of products previously registered by SRAs and PAHO Regional Level IV authorities. Review in 10 working days (in practice it currently turns out to be longer) Indonesia Abridged review Abridged review New registration (NCE or biological) or variation of new indication/posology approved in more than 3 countries with known good evaluation system 150 days assessment instead of 300 days Jordan Fast Registration Pathway Verification review New chemical entities and new biologics registered by US FDA and/or EMA AND post-approval changes approved by US FDA and EMA. Review within 60 days Macedonia Accelerated procedure Verification review Products registered via EMA only 15 days review time (in practice 4-18 months) Mexico Equivalence agreements Abridged review New chemical entities and new biotech products registered by SRAs as EMA, TGA, Swiss Medic and Health Canada Review within 3 months after the file is submitted and reviewed by a third authorized party (in practice currently takes longer) Montenegro Accelerated Verification Products registered via 150 days review time
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.
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
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
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
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,