Table 1.

Phases, Milestones, and Intervals Used for Calculating the Swissmedic Timelines as Mapped in Fig. 1

Phase	Type	Swissmedic milestones	Process map interval (Fig. 1)
Validation	Agency and company time	Submission date—accepted for review	A → B
Scientific assessment
Scientific assessment I	Agency time only	Accepted for review—list of questions (LoQ) or preliminary decision sent to applicant (if no LoQ is issued)	B → C
Applicant response to agency questions	Company time only	LoQ sent to applicant—applicant’s answers to LoQ received	C → D
Scientific Assessment II	Agency time only	Applicant’s answers to LoQ received—preliminary decision sent to applicant	D → E
Authorisation (Swissmedic Labelling Phase)
Applicant’s response to agency’s last Preliminary Decision	Company time only	Last preliminary decision sent to applicant—applicant’s answers to the last preliminary decision received	E → F
Assessment of applicant’s response to the last Preliminary Decision	Agency (and company time in case of additional “labelling loops”)	Applicant’s answers to preliminary decision received—official approval letter sent to applicant (granting of marketing authorisation)	F → G
Total approval	Agency and company time	Submission date—official approval letter sent to applicant (granting of marketing authorisation)	A → G
Total agency scientific assessment	Agency time only	Scientific assessment I + scientific assessment II	(B → C) + (D → E)
Total agency and company scientific assessment	Agency and company time	Start of scientific assessment I—preliminary decision sent to applicant	B → E