My luminous padlet by Ernest Ng https://padlet.com/19012211/4q01kcosodi4fm95 Made with ♥ en-us 2020-11-19 04:43:10 UTC 2020-11-19 06:10:46 UTC hello@padlet.com No rmahaa1405 https://padlet.com/19012211/4q01kcosodi4fm95/wish/939838175 2020-11-19 04:50:10 UTC https://padlet.com/19012211/4q01kcosodi4fm95/wish/939838175 Is the product registered in Singapore? rmahaa1405 https://padlet.com/19012211/4q01kcosodi4fm95/wish/939838817 2020-11-19 04:50:31 UTC https://padlet.com/19012211/4q01kcosodi4fm95/wish/939838817 Yes peggyseahy https://padlet.com/19012211/4q01kcosodi4fm95/wish/939839519 2020-11-19 04:50:56 UTC https://padlet.com/19012211/4q01kcosodi4fm95/wish/939839519 Essentially similar to a currently registered product? rmahaa1405 https://padlet.com/19012211/4q01kcosodi4fm95/wish/939840500 2020-11-19 04:51:31 UTC https://padlet.com/19012211/4q01kcosodi4fm95/wish/939840500 Contain new chemical or biological entity? peggyseahy https://padlet.com/19012211/4q01kcosodi4fm95/wish/939840885 2020-11-19 04:51:44 UTC https://padlet.com/19012211/4q01kcosodi4fm95/wish/939840885 Post-approval process, chapter F 19012211 https://padlet.com/19012211/4q01kcosodi4fm95/wish/939841608 2020-11-19 04:52:08 UTC https://padlet.com/19012211/4q01kcosodi4fm95/wish/939841608 NDA-1 rmahaa1405 https://padlet.com/19012211/4q01kcosodi4fm95/wish/939846662 first strength of a product containing new chemical or biological entity ]]> 2020-11-19 04:54:56 UTC https://padlet.com/19012211/4q01kcosodi4fm95/wish/939846662 No peggyseahy https://padlet.com/19012211/4q01kcosodi4fm95/wish/939846962 2020-11-19 04:55:07 UTC https://padlet.com/19012211/4q01kcosodi4fm95/wish/939846962 NDA-2 rmahaa1405 https://padlet.com/19012211/4q01kcosodi4fm95/wish/939847051 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
]]> 2020-11-19 04:55:10 UTC https://padlet.com/19012211/4q01kcosodi4fm95/wish/939847051 No peggyseahy https://padlet.com/19012211/4q01kcosodi4fm95/wish/939847976 2020-11-19 04:55:43 UTC https://padlet.com/19012211/4q01kcosodi4fm95/wish/939847976 Yes 19012211 https://padlet.com/19012211/4q01kcosodi4fm95/wish/939848238 2020-11-19 04:55:51 UTC https://padlet.com/19012211/4q01kcosodi4fm95/wish/939848238 First strength of product? 19012211 https://padlet.com/19012211/4q01kcosodi4fm95/wish/939850735 2020-11-19 04:57:10 UTC https://padlet.com/19012211/4q01kcosodi4fm95/wish/939850735 Yes peggyseahy https://padlet.com/19012211/4q01kcosodi4fm95/wish/939851196 2020-11-19 04:57:26 UTC https://padlet.com/19012211/4q01kcosodi4fm95/wish/939851196 GDA-1 19012211 https://padlet.com/19012211/4q01kcosodi4fm95/wish/939856189 For the first strength of a generic chemical product]]> 2020-11-19 05:00:03 UTC https://padlet.com/19012211/4q01kcosodi4fm95/wish/939856189 GDA-2 19012211 https://padlet.com/19012211/4q01kcosodi4fm95/wish/939856515 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]]> 2020-11-19 05:00:13 UTC https://padlet.com/19012211/4q01kcosodi4fm95/wish/939856515 Yes 19012211 https://padlet.com/19012211/4q01kcosodi4fm95/wish/939856733 2020-11-19 05:00:19 UTC https://padlet.com/19012211/4q01kcosodi4fm95/wish/939856733 No 19012211 https://padlet.com/19012211/4q01kcosodi4fm95/wish/939856882 2020-11-19 05:00:24 UTC https://padlet.com/19012211/4q01kcosodi4fm95/wish/939856882 Application dossier requirements rmahaa1405 https://padlet.com/19012211/4q01kcosodi4fm95/wish/939861254 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.]]> 2020-11-19 05:02:52 UTC https://padlet.com/19012211/4q01kcosodi4fm95/wish/939861254 Pre-submission 19012211 https://padlet.com/19012211/4q01kcosodi4fm95/wish/939880957 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 ]]> 2020-11-19 05:13:30 UTC https://padlet.com/19012211/4q01kcosodi4fm95/wish/939880957 Evaluation route 19012211 https://padlet.com/19012211/4q01kcosodi4fm95/wish/939893261 2020-11-19 05:20:07 UTC https://padlet.com/19012211/4q01kcosodi4fm95/wish/939893261 Full evaluation route 19012211 https://padlet.com/19012211/4q01kcosodi4fm95/wish/939900836 New product has not been approved by any drug regulatory agency
Only new drug application (NDA)]]> 2020-11-19 05:23:58 UTC https://padlet.com/19012211/4q01kcosodi4fm95/wish/939900836 NDA-3 19012211 https://padlet.com/19012211/4q01kcosodi4fm95/wish/939912346 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]]> 2020-11-19 05:30:26 UTC https://padlet.com/19012211/4q01kcosodi4fm95/wish/939912346 Abridged evaluation route rmahaa1405 https://padlet.com/19012211/4q01kcosodi4fm95/wish/939922743 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)]]> 2020-11-19 05:35:53 UTC https://padlet.com/19012211/4q01kcosodi4fm95/wish/939922743 Verification evaluation route 19012211 https://padlet.com/19012211/4q01kcosodi4fm95/wish/939929787 Any new or generic product that has been approved by our reference drug regulatory agencies
Evaluation route applies to both NDA and GDA]]> 2020-11-19 05:39:39 UTC https://padlet.com/19012211/4q01kcosodi4fm95/wish/939929787 Verification CECA evaluation route rmahaa1405 https://padlet.com/19012211/4q01kcosodi4fm95/wish/939930665 generic product manufactured in India which has been approved by our reference drug regulatory agencies.
only applies to GDA of products manufactured in India.]]> 2020-11-19 05:40:07 UTC https://padlet.com/19012211/4q01kcosodi4fm95/wish/939930665 Application screening and evaluation stages 19012211 https://padlet.com/19012211/4q01kcosodi4fm95/wish/939947545 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. 
]]> 2020-11-19 05:49:03 UTC https://padlet.com/19012211/4q01kcosodi4fm95/wish/939947545 completed 19012211 https://padlet.com/19012211/4q01kcosodi4fm95/wish/939952589 2020-11-19 05:51:43 UTC https://padlet.com/19012211/4q01kcosodi4fm95/wish/939952589 Regulatory Decision rmahaa1405 https://padlet.com/19012211/4q01kcosodi4fm95/wish/939958064 2020-11-19 05:54:34 UTC https://padlet.com/19012211/4q01kcosodi4fm95/wish/939958064 Post-approval changes rmahaa1405 https://padlet.com/19012211/4q01kcosodi4fm95/wish/939959236 2020-11-19 05:55:14 UTC https://padlet.com/19012211/4q01kcosodi4fm95/wish/939959236 Approval rmahaa1405 https://padlet.com/19012211/4q01kcosodi4fm95/wish/939960288 2020-11-19 05:55:47 UTC https://padlet.com/19012211/4q01kcosodi4fm95/wish/939960288 Non-approval withdrawal rmahaa1405 https://padlet.com/19012211/4q01kcosodi4fm95/wish/939961061 2020-11-19 05:56:11 UTC https://padlet.com/19012211/4q01kcosodi4fm95/wish/939961061