;   Medical Translation Insight: eCTD vs. RPS - ForeignExchange Translations

eCTD vs. RPS

eCTD vs. RPSOh no, say it isn't so: Just as the electronic common technical document (eCTD) is gaining traction as the required format for electronic regulatory submissions, the Food and Drug Administration is changing the game, says Bio-IT World.

The threat (or improvement, depending on how you look at it) comes in the form of Regulated Product Submissions (RPS). RPS seems to offer advantages to pharma companies that either 1) have a large product portfolio beyond drugs and biologics (e.g., P&G) or 2) are smaller and cannot currently leverage eCTD (e.g., animal health, OTC, consumer health). It promises to have a more flexible approach to structure that would allow the CTD to be submitted as an RPS.

RPS could represent a substantial cost to an industry which is already having a hard time implement the eCDT format. However, anyone in pharmaceutical regulatory affairs should pay close attention to this.

Similarly, translation service providers that are just getting used to the eCTD structure and interface may need to broaden their knowledge.

The good news? RPS won't be in production use at FDA until September 2011.

ForeignExchange Translations provides specialized medical translations for electronic as well as paper-based regulatory submissions. Contact us to find out more.


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