RPS Working Group Reviews ICH Requirements

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The RPS (Regulated Product Submissions) Working Group met last week in Atlanta. The main discussion points were around ICH requirements, multi product submission, facility submissions, linking to other applications, multi regulator submission and how should the project be managed going forward.

All current ICH requirements were reviewed. Most of the requirements are already met. Some more requirements need to be addressed.

I expect both Europe and Japan, in regards to human pharmaceutics, to submit new requirements in the next 3-6 months either through ICH or directly. I would not expect these requirements to be ground breaking.

Device attendance was lower than I hoped; but they were present. To gather more support within the device community, the device folks would like to have a joint project with ISO TC 210 Quality management and corresponding general aspects for medical devices. This is different TC that the human pharmaceutics folks are accustomed to work with, namely, ISO TC 215 Health Informatics.

There was a small change to the management process; that is, less phone calls.

The next milestone for the project is the January DSTU ballot. I would expect the FDA to test the draft standard, and depending on the test results, implement.


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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