When RPS Does Not Mean Rock Paper Scissors
By Scott Mackey | September 9, 2010
Google the term, RPS, and the first two pages of search results are dominated by links about the two-handed child’s game, Rock Paper Scissors (and what is now an international adult sporting event).
However, in our world, RPS stands for Regulated Product Submissions – the highly anticipated replacement for eCTD (Electronic Common Technical Document), which is currently the electronic standard for submissions to the FDA.
You could say that RPS has something in common with the more commonly known acryonm for the fist-shaking game– insofar as the adoption of an electronic submission process that leverages RPS means a pharmaceutical company can…
- ROCK their profitability goals…
- by automating inefficient PAPER processes…
- which significantly SCISSORS their costs!
The new submission standard, RPS, was developed by HL7, the global authority on standards for interoperability of health IT, with members in 55+ countries. RPS builds on the achievements of the eCTD, which was developed by the ICH, the joint work of European, US and Japanese pharma experts who discuss product registration.
Pharmaceutical companies sell drugs to the market for the betterment of society and to turn a profit. Before they can do that, though, their substances must be rigorously tested and documented. The result is an organized collection of documents and data that the regulatory body – such as the FDA in the US – must review and approve.
Attention to detail, quality of content and ease of navigation can all serve to make the FDA reviewers’ life easier – accelerating the review and approval process, so that Big Pharma can get their product to market faster. Getting a new drug to market can mean more than $1 million a day to the manufacturer, not to mention that drug patents expire in a limited window of time – so time is of the essence.
Electronic submission standards dictate the structure of the XML “backbone” file which provides metadata about content files (submission-ready PDFs and SAS datasets) and lifecycle instructions for the receiving system. It allows the submission to be created by the pharma company, then imported into the review tools used by the FDA, making it easier for them to navigate the submission.
Life sciences live and breathe PDF as a centralized component of their regulatory submission process. If you’ve got 4 minutes, watch my video that expands on the role of submission-ready PDFs.
The newer kid on the standards block, Regulated Product Submission, promises to make the submission process easier to share across multiple stakeholders. RPS does not change the basic contents of the submission, which is comprised of high-quality linked PDFs and datasets.
I’m looking forward to talking more about the RPS, eCTD and how Big Pharma is optimizing their use of electronic submissions by leveraging PDF rendering solutions, including the PDF archive standard, PDF/A, in a couple of weeks at LORENZ userBridge conference in Germany.
About the Author
As a senior executive, Scott has spent the last 20 years building Adlib into the thriving organization it is today. Scott has held customer-focused leadership roles spanning success, professional services, marketing, and support. He is passionate about business growth, the human impact of technology, and the pursuit of an ideal customer experience measured in the customers’ terms.