What regulatory steps are required to obtain approval for a new drug in Singapore under the Medicines Act?

Hello,

Thank you for reaching out. I understand you are developing a new medicinal product and are seeking to understand the regulatory requirements for obtaining marketing approval in Singapore. Below is a detailed overview of the process, which I hope you will find helpful.

Regulatory Authority and Framework
In Singapore, the Health Sciences Authority (HSA) is the regulatory body responsible for evaluating and approving new drugs. The primary legislation governing the registration of therapeutic products is the Health Products Act (HPA).​

Regulatory Pathway and Dossier Requirements
To market a new drug in Singapore, you must submit a New Drug Application (NDA) to the HSA. The application and supporting documents are submitted electronically through the HSA's online portal, the Pharmaceutical Regulatory and Information System (PRISM). You will need an active Company Registration for e-Services account to access PRISM.​

The application dossier should be prepared in the Common Technical Document (CTD) or eCTD format. The required documentation depends on whether the drug has been approved by other regulatory agencies. There are three main types of evaluation dossiers:​

Full Evaluation Dossier: Required for new drugs that have not been evaluated or approved by any other regulatory agency.

Abridged Evaluation Dossier: For drugs that have been approved by at least one major regulatory agency.

Verification Evaluation Dossier: For drugs approved by a stringent regulatory authority with no significant differences from the approved product.

Clinical Data and GMP Compliance
Your application must include comprehensive data to support the quality, safety, and efficacy of the drug. This includes preclinical and clinical data. The HSA also requires evidence of Good Manufacturing Practice (GMP) compliance for the drug substance manufacturer. Acceptable GMP evidence includes:​

A GMP certificate or inspection report from a Pharmaceutical Inspection Co-operation Scheme (PIC/S) authority.​

A valid Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP).

As of October 1, 2024, providing GMP compliance evidence for drug substances is a mandatory requirement for all new and generic drug applications​.

Evaluation Process and Timelines
The HSA evaluates the dossier to ensure it meets the required standards. The evaluation process generally follows these steps:​

Pre-Submission Consultation: You have the option to consult with the HSA before submitting your application to clarify any requirements.​

Application Submission: The application is submitted via the PRISM portal.​

Screening: The HSA conducts an initial screening for deficiencies. If any are found, you have 20 working days to provide the requested information.​

Evaluation: The HSA's multidisciplinary experts conduct a scientific review of the dossier.​

Regulatory Decision: Based on the evaluation, the HSA will decide whether to grant marketing authorization.​

The target processing timelines vary depending on the type of dossier submitted:​

Full evaluation dossiers: 270 working days.

Abridged evaluation dossiers: 120-240 working days.

Verification evaluation dossiers: 60-120 working days.

For life-saving drugs that address unmet medical needs, a priority review may be granted, which can shorten the review timeline.​

Associated Costs
The fees for a new drug application vary depending on the evaluation route. As of July 1, 2024, the application fee for a new drug application is S$560. The evaluation fees for a full route application can range from S$3,900 to S$12,000, and up to S$75,600 for a product containing a registrable drug. Please note that fees are subject to change, and the most current fee schedule is available on the HSA website.​

I hope this overview provides a clear understanding of the regulatory landscape in Singapore. The process can be complex, and the specific requirements will depend on the nature of your product.

For more detailed and personalized guidance tailored to your specific product, I would be happy to offer a consultation service via WhatsApp at a competitive rate. Please feel free to reach out to discuss your needs further.

Best regards.

Hello,

Thank you for reaching out. I understand you are developing a new medicinal product and are seeking to understand the regulatory requirements for obtaining marketing approval in Singapore. Below is a detailed overview of the process, which I hope you will find helpful.

Regulatory Authority and Framework
In Singapore, the Health Sciences Authority (HSA) is the regulatory body responsible for evaluating and approving new drugs. The primary legislation governing the registration of therapeutic products is the Health Products Act (HPA).​

Regulatory Pathway and Dossier Requirements
To market a new drug in Singapore, you must submit a New Drug Application (NDA) to the HSA. The application and supporting documents are submitted electronically through the HSA's online portal, the Pharmaceutical Regulatory and Information System (PRISM). You will need an active Company Registration for e-Services account to access PRISM.​

The application dossier should be prepared in the Common Technical Document (CTD) or eCTD format. The required documentation depends on whether the drug has been approved by other regulatory agencies. There are three main types of evaluation dossiers:​

Full Evaluation Dossier: Required for new drugs that have not been evaluated or approved by any other regulatory agency.

Abridged Evaluation Dossier: For drugs that have been approved by at least one major regulatory agency.

Verification Evaluation Dossier: For drugs approved by a stringent regulatory authority with no significant differences from the approved product.

Clinical Data and GMP Compliance
Your application must include comprehensive data to support the quality, safety, and efficacy of the drug. This includes preclinical and clinical data. The HSA also requires evidence of Good Manufacturing Practice (GMP) compliance for the drug substance manufacturer. Acceptable GMP evidence includes:​

A GMP certificate or inspection report from a Pharmaceutical Inspection Co-operation Scheme (PIC/S) authority.​

A valid Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP).

As of October 1, 2024, providing GMP compliance evidence for drug substances is a mandatory requirement for all new and generic drug applications.​

Evaluation Process and Timelines
The HSA evaluates the dossier to ensure it meets the required standards. The evaluation process generally follows these steps:​

Pre-Submission Consultation: You have the option to consult with the HSA before submitting your application to clarify any requirements.​

Application Submission: The application is submitted via the PRISM portal.​

Screening: The HSA conducts an initial screening for deficiencies. If any are found, you have 20 working days to provide the requested information.​

Evaluation: The HSA's multidisciplinary experts conduct a scientific review of the dossier.​

Regulatory Decision: Based on the evaluation, the HSA will decide whether to grant marketing authorization.​

The target processing timelines vary depending on the type of dossier submitted:​

Full evaluation dossiers: 270 working days.

Abridged evaluation dossiers: 120-240 working days.

Verification evaluation dossiers: 60-120 working days.

For life-saving drugs that address unmet medical needs, a priority review may be granted, which can shorten the review timeline.​

Associated Costs
The fees for a new drug application vary depending on the evaluation route. As of July 1, 2024, the application fee for a new drug application is S$560. The evaluation fees for a full route application can range from S$3,900 to S$12,000, and up to S$75,600 for a product containing a registrable drug. Please note that fees are subject to change, and the most current fee schedule is available on the HSA website.​

I hope this overview provides a clear understanding of the regulatory landscape in Singapore. The process can be complex, and the specific requirements will depend on the nature of your product.

For more detailed and personalized guidance tailored to your specific product, I would be happy to offer a consultation service via WhatsApp at a competitive rate. Please feel free to reach out to discuss your needs further.

Best regards.