Compound Documents Left Out of RPS Standard

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Compound documents will not be part of the Regulated Product Submissions (RPS) standard. The decision was recently announced by the International Conference on Harmonisation’s (ICH) M8 working group which had been deliberating on a number of negative ballot comments registered in September 2013.

Next for RPS, destined to become Electronic Common Technical Document (eCTD) v4.0, is another round of HL7 balloting in August/September. Implementation based on the current timeline wouldn’t take place until 2016 at the earliest, and is likely to include a pilot program.

The removal of compound documents from the RPS standard is a victory for simplicity and favors the majority of industry stakeholders. Compounds documents represents one way to meet the requirement of re-using documentation in different sequences. However, all parties involved are in agreement that the reuse requirement can be accomplished with publishing software without including compound documents in the RPS standard.

Innovation and flexibility on the publishing side would have been impaired if vendors and sponsors were beholden to an RPS standard that included compound documents.

Author: Jason Rock

Jason Rock is a pioneer in the field of electronic submissions. Mr. Rock has an extensive background working with global life sciences companies and regulatory agencies to promote eCTD adoption through the development of advanced applications. The commercial software Mr. Rock originally developed, and continues to improve, in his role as Chief Technical Officer for GlobalSubmit, is used exclusively by the U.S. Food & Drug Administration to review and validate all eCTD submissions the FDA receives.

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