Registration of Class 2 CTGTP

  1. Registration overview

Registration overview

Product registration is required for Class 2 CTGTP. Understand the registration process before submitting your application.

Application types

There are three application types to register a Class 2 CTGTP:

Application
type		 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
  1. For the first strength of a product containing:
    • New combination of registered CTGTP or
    • Registered CTGTP in either of the following:
      • New dosage form, such as suspension for intravenous infusion and powder for injection
      • New presentation, such as single-dose vials, freezing bags and pre-filled syringes
      • New formulation
      • New route of administration

      OR

  2. For products that do not fall under the requirements for NDA-1 or NDA-3.
NDA-3 For subsequent strengths of a CTGTP that has been registered or submitted as an NDA-1 or NDA-2.

The product name, dosage form, indication, dosing regimen and patient population should be the same as that for the NDA-1 or NDA-2 submission.

Evaluation routes

Applications are processed via a specific evaluation route, which will determine the documents required, fees and evaluation turnaround time:

Evaluation
route		 Conditions
Full

Any new CTGTP that has not been approved by any of our comparable overseas regulators at the time of submission.

Pre-submission notification is required for this route (details below).
Abridged

Any new CTGTP that has been approved by at least one of our comparable overseas regulators at the time of submission.

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.

Next Application submission