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Application screening and evaluation stages

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Application screening and evaluation stages

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Application screening to ensure application type is correct and the dossier is complete.
The screening will not be done if:

the entire dossier section not submitted

the submitted application is not compiled according to CTD format

Drug master file not submitted

assessment reports are not submitted

Screening time for NDA and GDA is 50 working days
There are 4 stages of evaluation stages and it only begins after the application is accepted upon screening.

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generic product manufactured in India which has been approved by our reference drug regulatory agencies.
only applies to GDA of products manufactured in India.

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Any new or generic product that has been approved by our reference drug regulatory agencies
Evaluation route applies to both NDA and GDA

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new or generic product that has been approved by at least one drug regulatory agency.
For new drug application (NDA) and generic drug application (GDA)

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product that as been submitted as an NDA-1 or NDA-2.
The product name, dosage form, indication, dosing regimen and patient population should be the same as NDA-1 or NDA-2

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New product has not been approved by any drug regulatory agency
Only new drug application (NDA)

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2 month before NDA full evaluation
Things to include
- product name
- active ingredients
- summaries of quality, non-clinical and clinical data
- planned submission in other countries
-planned date of submission to HSA

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Submit the application dossier within 2 working days of the PRISM application and organise it in either an ICH Common Technical document (CTD) or ASEAN CTD (ACTD) format.

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For subsequent strength(s) of the generic chemical product that has been registered or submitted as GDA-1. The product name and dosage form should be the same as that for the GDA-1

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For the first strength of a generic chemical product

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First strength of a product
- containing a new combination of registered chemical or biological entities
- contain registered chemical or biological entities in :

new dosage form

new presentation

new formulation

new route of administration

new indication, dosage recommendation or patient population

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first strength of a product containing new chemical or biological entity

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Contain new chemical or biological entity?

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Contain new chemical or biological entity?

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Essentially similar to a currently registered product?

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Essentially similar to a currently registered product?