Pharmaceuticals Registration Submission Format in Singapore

L

LQ. Fanny Lozano

#1
Hi everyone!!

Just for supporting: I know that Singapore has its "very own" format for Pharmaceuticals registration, however this format is based on the ASEAN (ACTD) format for registration of Pharmaceuticals for Human use, so.....I'm submiting a product in Singapore but on Malaysia too, can I use the ACTD format respecting its order but including Singapores' "own" requirements? Could I get in trouble with Singapores regulatory authorities for doing this?
Thank you so much, have a nice day!! :)
 
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Stijloor

Staff member
Super Moderator
#2
Hi everyone!!

Just for supporting: I know that Singapore has its "very own" format for Pharmaceuticals registration, however this format is based on the ASEAN (ACTD) format for registration of Pharmaceuticals for Human use, so.....I'm submitting a product in Singapore but on Malaysia too, can I use the ACTD format respecting its order but including Singapore's "own" requirements? Could I get in trouble with Singapore's regulatory authorities for doing this?

Thank you so much, have a nice day!! :)
Can someone with this expertise help Fanny?

Thank you very much!!

Stijloor.
 

sreenu927

Quite Involved in Discussions
#3
Hi,

As long as you provide the documents in ASEAN CTD format and submitting the supporting declaration letters or whatever it is, as provided in the website, then you are safe. See below url for your reference:
http://www.hsa.gov.sg/publish/hsapo..._regulation/western_medicines/guidelines.html

If there is anything missing that is major, then they "may" reject your application. Else they seek further information through "input request".

Regards,
Sreenu
 
L

LQ. Fanny Lozano

#4
Thanks Sreenu!!

I would do my best for not missing a single document in order to avoid rejection.
Thanks, regards!
 
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