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 therapeutic product registration.
Pre-submission preparation
The following are important considerations before you register your therapeutic product.
| Considerations |
Options |
| Identify which application type to apply for.
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- New drug application (NDA-1, NDA-2, NDA-3).
- Generic drug application (GDA-1, GDA-2).
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| Know which evaluation route to choose. You can decide on this within the registration guides later.
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- Full (NDA only).
- Abridged.
- Verification.
- Verification-CECA (GDA only).
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| Choose an application dossier format. You can decide on this within the registration guides later.
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You may choose to submit your application dossiers in one of the following formats:
- International Council for Harmonisation Common Technical Document (ICH CTD).
- ASEAN Common Technical Document (ACTD).
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Note:Different formulations, dosage forms and strengths of the same chemical or biologic entity are considered different products, and will require separate registrations.
Product types
Therapeutic products could contain either chemical or biological entities as the active ingredients.
A chemical entity refers to any chemical element, naturally occurring chemical material or chemical product obtained by chemical change or synthesis. This includes macromolecules produced by chemical synthesis, such as peptides and oligonucleotides, or any metabolites from a micro-organism, such as antibiotics.
A biological entity refers to any macromolecule extracted from an organism, such as proteins, nucleic acids, proteoglycans, cytokines and growth factors. It can also refer to any substance derived from a biological system, including:
- A whole cell or micro-organism, such as a whole virus or bacterium used as a vaccine.
- A part of a micro-organism, such as a sub-unit vaccine.
- A plasma-derived product.
- A biotechnology-derived substance, such as a protein or polypeptide.
Forensic classifications
You may register your therapeutic product under the following forensic classifications, which determine the level of access control:
- Prescription-Only Medicines (POM):A therapeutic product that can only be obtained from a doctor or a dentist, or from a pharmacist with a prescription from a doctor or a dentist. The condition to be treated needs to be diagnosed and treated by a doctor. It can also have serious side effects which require a doctor's monitoring or follow up.
- Pharmacy Only Medicines (P): A therapeutic product that can be obtained from a pharmacist at a retail pharmacy. The condition is self-limiting and can be assessed and treated by pharmacists.
- General Sale List (GSL): A therapeutic product that can be freely obtained from any retailer. It can be used safely by the public without medical supervision and intended for short term self-treatment only.
Overseas manufacturers of therapeutic products
All new overseas manufacturers who intend to register therapeutic products in Singapore after 1 April 2004 will be subjected to a Good Manufacturing Practice (GMP) conformity assessment by us.