Table 2.

Target Timelines for Swissmedic, EMA, and FDA Standard Review Processes for New Active Substances

Phase	Validation	Scientific assessment	Authorisation
Swissmedic	30 days + 60 days for applicant in case of an incomplete dossier	Agency—210 days total	60 days for applicant to respond to Preliminary Decision
		120 days for scientific assessment I
		90 days for scientific assessment II	90 days for agency to respond to applicant’s response on preliminary decision
		Applicant: 90 days for applicant response to LoQ
EMA	13 working days +  ~ 2 months for applicant reply	Agency (210 days total):	67 days for European Commission
		120 days for scientific assessment I
		90 days for scientific assessment II
		Applicant: 2 months clock stop after Sci. Assessment I can be extended up to 6 months
FDA	60 days for filing notification to applicant	Agency: 10 months first cycle review (scientific assessment I)	Not applicable [the FDA action letter to approve is signed (FDA action date)]. This is equivalent to the regulatory approval, and therefore for FDA, time from acceptance of submission to end scientific assessment and time from acceptance of submission to approval are the same
		Up to 6 months for resubmission evaluation (scientific assessment II)
		Applicant: 30 days to respond to complete response letter and request extension