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Registration overview of Class 2 CTGTP

  1. Registration process

Registration process

Understand the registration process for your Class 2 CTGTP before you submit your application.

Who can register

You will need to be a local company registered with the Accounting and Corporate Regulatory Authority (ACRA) in order to proceed with a product registration.

Pre-submission preparation

The following are important considerations before you register your Class 2 CTGTP.

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

(a)  For the first strength of a product containing:

    • New combination of registered CTGTP.
    • Registered CTGTP in either of the following:
      • New dosage form, such as capsules and injectables.
      • New presentation, such as single-dose vials, multi-dose vials and pre-filled syringes.
      • New formulation, such as preservative-free.
    • Registered CTGTP for use by a new route of administration.

(b)  For products that do not fall under the requirements for NDA-1 or NDA-3.

NDA-3 For subsequent strengths of a product that has been registered or submitted as a 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

Each product registration is done via a specific evaluation route. The evaluation route will determine the turn-around-time (TAT), fees and documents required for registration.

Evaluation route Eligibility
Full

Any new product that has not been approved by any comparable overseas regulator at the time of submission.

Abridged

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

Comparable overseas regulators

Our comparable overseas regulators are the following:

  • Therapeutic Goods Administration (TGA, Australia)
  • Health Canada (HC, Canada)
  • Food and Drug Administration (FDA, United States of America)
  • European Medicines Agency (EMA)
  • Medicines and Healthcare Products Regulatory Agency (MHRA, United Kingdom)

Pre-submission notification

Notify us at least two months before you submit your full evaluation application via email to HSA_CTT_Enquiry@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.

Note: You may request for a pre-market consultation with us if it is necessary to discuss specific areas related to your application, including the need for an overseas Good Clinical Practice (GCP) inspection, where relevant. Your meeting request to us must be made at least four weeks before the proposed meeting date, with the meeting agenda clearly stated. Relevant documents such as presentation slides and briefing documents should be provided at least one week before the meeting.

Application dossier

Application dossiers are technical documents accompanying your new CTGTP  registration (NDA). They should be submitted within two working days of the application submission.

Types of application dossier formats

Your application dossier submitted to us must be organised in either the International Council for Harmonisation Common Technical Document (ICH CTD) or the ASEAN CTD format. These formats use the modular framework described by the ICH Topic M4 and the ASEAN guidelines on the Common Technical Document for Registration of Pharmaceuticals for Human use: Organisation of the Dossier, respectively.

The table below summaries the organisation of each dossier format.

Documents Location in ICH CTD Location in ACTD
Administrative documents
Module 1
Part I
Common technical document overview and summaries
Module 2
Incorporated in Parts II, III and IV
Quality documents
Module 3
Part II
Non-clinical documents
Module 4
Part III
Clinical documents
Module 5
Part IV

Note: The CTD format cannot be changed once the application is submitted. Any subsequent variation applications for the product should follow the same format.

Overseas manufacturers of CTGTP

All new overseas manufacturers who intend to register CTGTP in Singapore will be subjected to a Good Manufacturing Practice (GMP) conformity assessment by us.

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