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.
- Any new product that has not been approved by any drug regulatory agency.
- This evaluation route only applies to new drug applications (NDA).
- Any new or generic product that has been approved by our reference drug regulatory agencies.
- This evaluation route applies to both NDA and GDA.
- Any generic product manufactured in India which has been approved by our reference drug regulatory agencies.
- This evaluation route only applies to GDA of products manufactured in India.
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:
- Australia Therapeutic Goods Administration (TGA)
- Health Canada (HC)
- US Food and Drug Administration (FDA)
- European Medicines Agency (EMA) via the Centralised Procedure
- UK Medicines and Healthcare Products Regulatory Agency (UK MHRA)
- This approval must be based on MHRA's own evaluation of the product via their own national procedure, or when they acted as the Reference Member State (RMS) to other EU countries via the Mutual Recognition Procedure or the Decentralised Procedure on or prior to 31 January 2020 when the UK has formally left the European Union.