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Provectus Biopharmaceuticals, Inc.

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Msg  32347 of 38097  at  6/28/2016 10:42:51 PM  by

canis_star


Australia

I find this website has lot of information about australia regulatory approval process. One thing i find very interesting about approved drugs in australia is that splnsor of every drug that approved has registered company in australia (pty limited).

https://www.tga.gov.au/prescription-medicines

https://www.tga.gov.au/australian-regulation-prescription-medical-products

https://www.tga.gov.au/prescription-medicines-registration-new-chemical-entities-australia

First sponsor need to submit eCTD before any approval ? Then the question is the submission of eCTD ( equivalent of NDA) application is an 8K material ?



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Recs: 8     Views: 470
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Replies
Msg # Subject Author Recs Date Posted
32348 Re: Australia vorlon1966 0 6/28/2016 11:01:03 PM
32354 Re: Australia agrossfarm 3 6/29/2016 12:31:41 AM
32380 Re: Australia travisnye 2 6/29/2016 1:51:19 PM
32384 Re: Australia travisnye 1 6/29/2016 2:14:43 PM


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