Hover over the steps involved in US regulatory review
Hover over the steps involved in the European Medicines Agency review process
Primary review
FDA sends questions to Idorsia on ongoing basis
Month
Day 0 Submit New Drug Application (NDA)
Day 60 FDA filing decision
By day 74 FDA issues application filing confirmation decision
Month 5 Mid-cycle meeting
Month 9 Late cycle meeting
Month 12 PDUFA date, or deadline for the FDA to review New Drug Application
In some cases: 90 days after PDUFA date
US Drug Enforcement Administration (DEA) publishes scheduling.
US regulatory standard review – FDA
Teams from across Idorsia collaborate to develop a robust and comprehensive dossier for submission to the health authorities. The data included is wide-reaching: preclinical research, such as compound screening, animal models and all pharmacology, pharmacokinetics and toxicology data; technical descriptions of the properties and chemical synthesis of the drug substance, as well as quality controls and procedures for pharmaceutical manufacturing; and complete results and analysis of each of the clinical studies and safety data collected over the course of clinical phases – in other words, the story of each molecule from bench to bedside.
Scheduling depends upon the drug's acceptable medical use and the drug's abuse or dependency potential.
Day 0 Submission of Marketing Authorisation Application (MAA)
Day
Day 14 Administrative
validation of dossier
Day 19 Start date
Day 120
List of questions to Idorsia
Day 121
Clock starts when Idorsia responds to question list
“Clock stop” ~3 months to respond to questions
Day 180
List of outstanding questions to Idorsia
Day 181
Clock starts
when Idorsia responds
“Clock stop”
Day 210
Committee for Medicinal Products for Human Use (CHMP) opinion
Day 277 European Commission decision granting Marketing Authorisation
Teams from across Idorsia collaborate to develop a robust and comprehensive dossier for submission to the health authorities. The data included is wide-reaching: preclinical research, such as compound screening, animal models and all pharmacology, pharmacokinetics and toxicology data; technical descriptions of the properties and chemical synthesis of the drug substance, as well as quality controls and procedures for pharmaceutical manufacturing; and complete results and analysis of each of the clinical studies and safety data collected over the course of clinical phases – in other words, the story of each molecule from bench to bedside.
EU regulatory standard review – EMA
Month 9 Late cycle meeting
Month 12 PDUFA date, or deadline for the FDA to review New Drug Application
By day 74 FDA issues application filing confirmation decision
Month 5
Mid-cycle meeting
Primary review
FDA sends questions to Idorsia on ongoing basis
Day 60 FDA filing decision
Month
In some cases: 90 days after PDUFA date US Drug Enforcement Administration (DEA) publishes scheduling.
Day 0 Submit New Drug Application (NDA)
Day 0
Teams from across Idorsia collaborate to develop a robust and comprehensive dossier for submission to the health authorities. The data included is wide-reaching: preclinical research, such as compound screening, animal models and all pharmacology, pharmacokinetics and toxicology data; technical descriptions of the properties and chemical synthesis of the drug substance, as well as quality controls and procedures for pharmaceutical manufacturing; and complete results and analysis of each of the clinical studies and safety data collected over the course of clinical phases – in other words, the story of each molecule from bench to bedside.
Day 90
Scheduling depends upon the drug's acceptable medical use and the drug's abuse or dependency potential.
Day
Day 14 Administrative
validation of dossier
Day 19 Start date
Day 120
List of questions to Idorsia
“Clock stop” ~3 months to respond to questions
Day 121
Clock starts when Idorsia responds to question list
Day 180
List of outstanding questions to Idorsia
“Clock stop”
Day 181
Clock starts when Idorsia responds
Day 210
CHMP opinion
Day 277 European Commission decision granting Marketing Authorisation
Day 0 Submission of Marketing Authorization Application (MAA)
Day 0
Teams from across Idorsia collaborate to develop a robust and comprehensive dossier for submission to the health authorities. The data included is wide-reaching: preclinical research, such as compound screening, animal models and all pharmacology, pharmacokinetics and toxicology data; technical descriptions of the properties and chemical synthesis of the drug substance, as well as quality controls and procedures for pharmaceutical manufacturing; and complete results and analysis of each of the clinical studies and safety data collected over the course of clinical phases – in other words, the story of each molecule from bench to bedside.