Types of evaluation routes
Each therapeutic product registration is done via a specific evaluation route. The evaluation route of your therapeutic product depends on:
- Type of your therapeutic product.
- Whether your therapeutic product has been approved by any overseas drug regulatory agencies.
The evaluation route of your therapeutic product will determine the turn-around-time (TAT), fees and documents required for registration.
Eligibility
- Any new product that has not been approved by any drug regulatory agency.
- This evaluation route only applies to new drug applications (NDA)
Pre-submission notification
Notify us at least two months before your NDA full evaluation submission with the following information:
- Product name.
- Active ingredients.
- Summaries of quality, non-clinical and clinical data.
- Planned submissions in other countries.
- Planned date of submission to HSA.
Note: You may request for a pre-submission consultation meeting with us only if it is necessary to discuss specific areas of concerns related to your application. Your meeting request to us must be made at least three 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.
Eligibility
- Any new or generic product that has been approved by at least one drug regulatory agency.
- This evaluation route applies to both new drug applications (NDA) and generic drug applications (GDA).
Priority review
You can request for a priority review for a life-saving drug if the drug is intended for treating:
- A serious life-threatening condition and can address local unmet medical needs such as:
- The absence of a treatment option.
- Lack of safe and effective treatments, such that the drug would be a significant improvement compared to available marketed products, as demonstrated by:
- Evidence of increased effectiveness in treatment, prevention, or diagnosis of a disease.
- Elimination or a substantial reduction of a treatment-limiting adverse reaction.
- Disease conditions of local public health concern, such as cancer and infectious diseases like dengue, tuberculosis, hepatitis and malaria.
To request for a priority review, state the request in the Introduction document of the application dossier and attach the relevant justifications and evidence such as:
- The seriousness of the disease condition, local and worldwide mortality rates, anticipated morbidity and debilitation as a consequence of the disease.
- Local epidemiology data and volume of requests through the exemption route on a named-patient basis.
- The unmet needs, current available treatment options and standard therapies, and the inadequacy of current therapies.
- The extent to which the product is expected to have a major impact on medical practice, its major benefit, and how it addresses the unmet needs.
- Clinical evidence supporting the claims of significant improvement compared to available treatments.
Eligibility
- Any new or generic product that has been approved by our reference drug regulatory agencies.
- This evaluation route applies to both NDA and GDA.
| NDA | 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.
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| GDA | You may register your generic drug via the verification evaluation route if it meets the following criteria: - Has been approved by at least one of our reference drug regulatory agencies at the time of submission.
- Has been approved within two years by the chosen reference agency.
- Has a declaration letter by the product owner or applicant stating that all aspects of the product’s quality are identical to that currently approved by the chosen reference agency. This includes the compulsory submission of the unredacted and unedited assessment reports and supporting documents from the chosen reference agency.
- Has not been rejected, withdrawn or approved via appeal process or pending deferral by a drug regulatory agency for safety or efficacy reasons.
Note: If a drug master file (DMF) is submitted, you must submit the unredacted and unedited assessment reports for the DMF and provide a separate declaration stating that the DMF you submitted is identical to the one submitted to the chosen reference agency. Refer to the Submission of Drug Master File for more information. Verification-CECA You may register your generic drug via the verification-CECA evaluation route if it meets the following criteria: - Same eligibility requirements as verification applications listed above.
- Generic drug must be manufactured in India.
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Fees
For new drug applications (NDA) and generic drug applications (GDA), two types of fees are payable:
- Screening fee, payable upon successful online application submission via PRISM.
- Evaluation fee, payable upon dossier acceptance for evaluation.
You may refer to the detailed therapeutic product fees and turn-around-time for more information.
Note: If payment is not made through GIRO, both screening and evaluation fees have to be paid upfront during submission. In this scenario, the evaluation fee will be refunded if the application is not accepted for evaluation.
Reference drug regulatory agencies
Our reference drug regulatory agencies consist of the following:
- US Food and Drug Administration (FDA)
- European Medicines Agency (EMA) via the Centralised Procedure
- Health Canada (HC)
- UK Medicines and Healthcare Products Regulatory Agency (UK MHRA)
- Swissmedic
- Australia Therapeutic Goods Administration (TGA)