Verification evaluation route for new drug application

Eligibility

You can submit a NDA to register your therapeutic product via the verification evaluation route if it:

• Has been approved by at least two of our reference drug regulatory agencies at the time of submission. The product has received full marketing approval by the reference agencies following a complete independent scientific assessment.
• Has been approved within three years by the chosen primary reference agency.
• Has a declaration letter by the product owner/applicant stating that all aspects of the product’s quality are identical to that currently approved by the primary reference agency. This includes the compulsory submission of the unredacted and unedited assessment reports and supporting documents from the chosen primary reference agency.
• Does not need an independent assessment by HSA to contextualise the benefit-risk profile due to local disease epidemiology, medical practice and/or public health considerations. Examples of products that may require such contextualised assessment are anti-infectives, vaccines, etc.
• Has not been rejected, withdrawn or approved via appeal process or pending deferral by a drug regulatory agency for safety or efficacy reasons.

NDA-3 applications

You may register the subsequent strength of a currently-registered therapeutic product as a NDA-3 via the verification evaluation route under one of the following conditions:

• Has been evaluated and approved by only one of our reference drug regulatory agencies, the NDA-3 must be submitted within two years from the date of approval of that reference drug regulatory agency.
• Has been evaluated and approved by at least two of our reference drug regulatory agencies, the NDA-3 must be submitted within three years from the date of approval by the chosen primary reference agency.

Note:

• The proposed indication, dosing regimen, patient group, and direction for use must be identical to the corresponding approved NDA-1 and NDA-2 products.
• The proposed PI/PIL are consistent with that currently approved for the corresponding NDA-1 and NDA-2 products.

Submission requirements

Application dossier requirements

You must submit the application dossier within 2 working days of the PRISM application and organise it in either an International Council for Harmonisation (ICH) Common Technical Document (CTD) or ASEAN CTD (ACTD) format. You need to submit all documents in English.

All administrative documents under Module 1 (ICH CTD) or Part I (ACTD) must be submitted in soft copy in PRISM.

The other parts of the ICH CTD or ACTD may be submitted online via PRISM or in a CD/DVD labelled with the following information:

• PRISM application number.

• PRISM submission date.

• Product name.

• Application type.

• Contents of the CD/DVD (e.g. Module 2 and 5).

Documents from primary reference agency

For an application submitted under this route, you need to declare one of the reference drug regulatory agencies as the primary reference agency from which the qualifying supporting documents will be submitted. This includes the compulsory submission of the unredacted and unedited assessment reports and supporting documents from the chosen primary reference agency. 

Note:

• If these documentary requirements for the verification route are not fulfilled, the application should be withdrawn. Any fees paid will not be refundable. A new application can then be submitted via the abridged route.