Here is the list of fees and turnaround time to help you with your cell, tissue and gene therapy products (CTGTP) transactions.
Fees: $95, payable at the point of application submission.
Turnaround time: The outcome of notification can be expected within 14 working days of your notification submission.
Click for application types and evaluation routes descriptions.
Click for submission guide for MAV-1 applications.
Click for submission guides for MIV applications.
MIV-1 application
MIV-2 application
All dealers dealing in minimally manipulated CTGTP are required to notify HSA on their activities prior to commencing the import, manufacture or wholesale of the CTGTP.
Fees: The applicable fees for a new dealer’s notice submission is $95. No fees are applicable for changes to a dealer’s notice.
All dealers dealing in a CTGTP which is not minimally manipulated are required to hold valid importer's or wholesaler's licence to import or wholesale the CTGTP, respectively.
All manufacturers are required to hold valid manufacturer’s licence to manufacture a CTGTP which is not minimally manipulated.
HSA may conduct a Good Manufacturing Practice (GMP) conformity assessment on overseas manufacturers as part of the product registration requirements.
Local dealers may voluntarily apply for the following certificates subject to compliance with the relevant standards:
Regulatory overview
Class 1 CTGTP notification
Register a Class 2 CTGTP
Variation applications
Dealer's notice
Dealer's licensing and certification
Risk management plan requirements
Report adverse events
Report or recall defective products
Clinical trials
Product consultation
Advertisements and promotions
Certificate of a Pharmaceutical Product
Duties And Obligations
Guidance documents
Fees and turnaround time
Notified Class 1 CTGTP
Register of Class 2 CTGTP
Register of Licensed CTGTP Importers, Wholesalers and Manufacturers
CTGTP E-services