RPS (Regulated Product Submission): The eCTD Successor?

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.

With this in mind, it is my feeling that companies that either 1) have a large product scope beyond just drug products and biologics (think P&G, etc) and 2) smaller organizations that focus on regulated products that cannot currently leverage eCTD (animal healths, OTCs, consumer health, etc.) have the most to gain from RPS and therefore will be the first to move towards adopting it.

For more information:

RPS Page at the National Cancer Institute
RPS Page at FDA
An Intro to RPS eBook

CBER to Require SPL?

One of the rumors coming out of DIA Annual is that CBER may soon (October timeframe) require all biologics marketing applications to use Structure Product Labels (SPL) for their labeling requirements.

This would be another interesting move forward as FDA continues to lead the way as far as electronic submissions go globally. We'll have to wait to find out exactly when this becomes a reality but if so remember you heard it hear first. :)

EU 1.3 Spec Released

The EU M1 1.3 Specification has been released. Here's the link to the information.

From the transition guidance document:

The Specifications and DTD of the eCTD EU Module 1 v1.3 include several changes to v1.2.1 (see Release Notes for EU M1 v1.3), but the principal change is alignment to the 2008 updated version of the CTD guidance, specifically to include section 1.10 for the information relating to paediatrics. The CTD M1 guidance and eCTD EU M1 specification are published simultaneously.

Applicants are given 6 months from the date of publication to implement EU M1 v1.3 for all European procedures, and eCTD applications submitted after 31st December 2008 using any previous version of the EU M1 specification (i.e. v1.0, v1.1 or v1.2.1) will not be accepted.

The 6 month deadline applies not only to new applications, but also to all lifecycle
sequences/submissions for applications ongoing at the time. Please note that, for existing applications, it is not expected that all existing submissions will be updated to EU M1 v1.3 and re-submitted; it is, however, expected that authoring and review tools will allow for a change in DTD mid-lifecycle.