Regulatory Open Forum

Dear RA community:

I'm filing a CTN Australia for a small molecule, which is an NCE. Recognizing in Australia a CTD Module 2.6 and Module 4 are not required, the only document that contains preclinical data is the investigators brochure (IB). 

In the U.S., normally it is required to generate preclinical Pharmacology, Safety Pharmacology, Pharmacokinetics, and GLP repeat dose Toxicology data before initiating first in human studies. While Australia observes ICH, is it really required/enforced to do all the same preclinical studies, or would basic PK and GLP Tox be sufficient. 

Thank you! 

Dear RA community:

I'm filing a CTN Australia for a small molecule, which is an NCE. Recognizing in Australia a CTD Module 2.6 and Module 4 are not required, the only document that contains preclinical data is the investigators brochure (IB). 

In the U.S., normally it is required to generate preclinical Pharmacology, Safety Pharmacology, Pharmacokinetics, and GLP repeat dose Toxicology data before initiating first in human studies. While Australia observes ICH, is it really required/enforced to do all the same preclinical studies, or would basic PK and GLP Tox be sufficient. 

Thank you! 

tx Harri. Can you please advise hoe CMC package is added in IB package in Australia. Is there different template for IB for TGA submission. 

Dear RA community:

I'm filing a CTN Australia for a small molecule, which is an NCE. Recognizing in Australia a CTD Module 2.6 and Module 4 are not required, the only document that contains preclinical data is the investigators brochure (IB). 

In the U.S., normally it is required to generate preclinical Pharmacology, Safety Pharmacology, Pharmacokinetics, and GLP repeat dose Toxicology data before initiating first in human studies. While Australia observes ICH, is it really required/enforced to do all the same preclinical studies, or would basic PK and GLP Tox be sufficient. 

Thank you! 

It's just a normal CMC section of an IB, i.e. a few pages. No need to go into too many details.

Harri Jarvelainen, DVM, PhD, MBA, DABT, ERT, Adj Prof

http://www.biotechgo.com/

https://www.linkedin.com/in/pharmaentrepreneur/<o:p></o:p>

tx Harri. Can you please advise hoe CMC package is added in IB package in Australia. Is there different template for IB for TGA submission. 

Dear RA community:

I'm filing a CTN Australia for a small molecule, which is an NCE. Recognizing in Australia a CTD Module 2.6 and Module 4 are not required, the only document that contains preclinical data is the investigators brochure (IB). 

In the U.S., normally it is required to generate preclinical Pharmacology, Safety Pharmacology, Pharmacokinetics, and GLP repeat dose Toxicology data before initiating first in human studies. While Australia observes ICH, is it really required/enforced to do all the same preclinical studies, or would basic PK and GLP Tox be sufficient. 

Thank you!