Table 1.

Target Timelines for MCC Review Procedures.

Process	Target
Validation	15 calendar days
Scientific assessment	90 calendar days
Sponsor response time (quality data)	180 calendar days
Sponsor response time (safety and efficacy data)	180 calendar days
Expert committee(s)	60 calendar days
Authorization procedure	60 calendar days
Notification of decision	7 calendar days
Overall review time (fast track)	NASs: 250 calendar days
Overall review time	NASs: No target

Abbreviations: MCC, Medicines Control Council; NASs, new active substances.