Replies to post #454620 on Anavex Life Sciences Corp (AVXL)

[Steady_T]

It is my understanding that large portions of NDAs are frequently contracted out to companies that specialize is preparing NDAs and MAAs.

I would expect Anavex to so the same. Maybe they will do it all in house. I don't know.

Sections of the applications such as the drug history, the manufacturing, trial results, MOA etc. will be the same. There has been an effort to "harmonize" the process between the EU and the US.

CTD (Common Technical Document)
In 2003, the members of ICH (International Council of Harmonization) have agreed to assembly all quality, safety and efficacy information in a common format which used to be called CTD. The CTD is a format/structure for Modules 1 through 5 of the NDA (New Drug Application), MAA (Marketing Authorization Application), and global medicinal applications. Module 1 contains administrative regional information which is differ for each country. Modules 2, 3, 4 and 5 are common for all regions. The CTD structure applies to both investigational and commercial applications (IND (Investigational New Drug) and NDA (US); IMPD (Investigational Medicinal Product Dossier) and MAA (EU), and global applications).

The CTD was primarily used for new marketing applications such as NDA, BLA (Biologics License Application), MAA, NDS (New Drug Substance), JNDA (Japanese New Drug Application), etc. With additional guidance and guidelines from the FDA and EMA, the CTD is now required for all applications, including those for clinical trials—IMPD and INDs. All Drug Master Files (DMF) and Active Substance Master Files (ASMF) must follow the structure of the CTD. The process of submitting regulatory dossier is regulated by Code of Federal Regulations (CFR) (Law in US) and Directives (Law in EU).