Alright, so if you're reading this blog, you probably buy into the eCTD as a viable standard. I know I certainly do, and the eCTD certainly has changed the way that drug applications are formatted, assembled, and trasmitted to the agencies. However, this blog also is very frank that eCTD is not the only bag in town when it comes to drug submissions. For right or wrong, and for reasons technical, cultural, legal, and beyond submissions formats such as paper CTD, NeeS, and others still exist and serve to prevent an across the board standardzation.
So, we see that eCTD still has room to grow as an established and mature standard...if that's the case, why even muddy the waters further by looking beyond eCTD?
- Scope. Since it's inception, eCTD was modeled off of the CTD formatting that existed in Europe to standardize submission structure for drugs and biologics. Well, there are many of types of regulated submissions out there beyond this: OTC, Consumer Products, Animal Health, Devices, etc. RPS promises to have a more flexible approach to structure that would allow the CTD or other structures to be submiteed as an RPS.
- Lifecycle. eCTD lifecycle is a one way street: sponsor to regulator. You submit your eCTD sequence to the regulator as a nicely organized dossier, and they get back to you via largely uncontrolled communication -- email, phone call, face-to-face meeting, etc. The RPS allows for a two-way street. You (as a sponsor) send a transmission to the regulator, the regulator in turn sends you a transaction back with their feedback comments, etc. This could relate much as eCTD lifecycle does -- at the document level so you could select a node and perhaps see sponsor feedback related to that sequence.
For more information:
RPS Page at the National Cancer Institute
RPS Page at FDA
An Intro to RPS eBook
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