Registration overview
Product registration is required for Class 2 CTGTP. Understand the registration process before submitting your application.
Last updated 2 April 2026
Application types
There are three application types to register a Class 2 CTGTP:
List of application types
Application | Conditions |
|---|---|
NDA-1 | For the first strength of a product containing a new CTGTP. This means the CTGTP is currently not registered in Singapore. |
NDA-2 |
OR
|
NDA-3 | For subsequent strengths of a CTGTP that has been registered or submitted as an NDA-1 or NDA-2. |
If your application is identified to be more appropriately submitted under a different application type during screening, you will be informed of the change via an input request.
Evaluation routes
Applications are processed via a specific evaluation route, which will determine the documents required, fees and evaluation turnaround time:
List of evaluation routes
Evaluation | Conditions |
Full | Any new CTGTP that has not been approved by any of our comparable overseas regulators at the time of submission. |
Abridged | Any new CTGTP that has been approved by at least one of our comparable overseas regulators at the time of submission. |
Comparable overseas regulators
HSA's comparable overseas regulators consist of the following:
Australia Therapeutic Goods Administration (TGA)
Health Canada (HC)
US Food and Drug Administration (FDA)
European Medicines Agency (EMA)
UK Medicines and Healthcare Products Regulatory Agency (UK MHRA)
Pre-submission notification
Notify us at least two months before you submit your full evaluation application via email to HSA_CTGTP@hsa.gov.sg with the following information
Product name
Active ingredients
Summaries of quality, non-clinical and clinical data e.g. Module 2.4 Non-clinical Overview, Module 2.5 Clinical Overview
Planned submissions in other countries
Planned date of submission to HSA
Fees and turnaround time
Refer to CTGTP fees and turnaround time for more information.
You are encouraged to make payment via GIRO (apply eGIRO).
GIRO deductions will be triggered as follows:
Screening fee, payable upon successful online application.
Evaluation fee, payable upon dossier acceptance for evaluation.
A notification on the successful GIRO deductions will be sent to the applicant’s email indicated in the application. All fees paid are non-refundable.
For non-GIRO applicants, an invoice will be sent to the applicant’s email indicated in the application.
GMP conformity assessment of overseas manufacturers
All new overseas manufacturers who intend to register CTGTP in Singapore will be subjected to a Good Manufacturing Practice (GMP) conformity assessment by us.
RMP submission
A risk management plan (RMP) must be submitted as part of the application dossier for all NDA-1 for CTGTP.
For other application types, including NDA-2/3 or variation applications, an RMP is to be submitted only upon HSA’s request during application review.
Environmental Risk Assessment (ERA)
The Genetic Modification Advisory Committee (GMAC) recommendation is required for CTGTP containing genetically modified organisms, e.g. viral vectors. You need to submit documentation of your GMAC application for ERA with the NDA application dossier and provide the GMAC assessment outcome once it is available.