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