Electronic records are everywhere these days - healthcare providers, patients, and now event manufacturers face that change. More and more pharmaceutical and medical device companies are preparing to submit applications to regulators electronically.
The healthcare IT standards organization Health Level Seven International (HL7) is creating a standard that will include guidelines on how to submit applications electronically for regulated drugs and medical devices to authorities around the world.
The most recent issue of AAMI News reports that HL7 plans to test the regulated product submission (RPS) in the fall of 2011, and the International Organization of Standardization plans to adopt the standard as early as 2013.
The article contains an interesting quote from Medtronic:
If anybody has ever looked at an XML file, it is scary. Software is going to be required for manufacturers to create submissions. There could be many different software packages that you could use, and some of them haven't been developed yet.Beyond the fear factor, other challenges remain. The May 2011 status report [PPT link] given to the HL7 WGM in Orlando points out that RPS requirements will be "phased in" because eCTD is already in place and that, in any case, EMA and Japan will not accept a new standard until it is an ISO standard.
It sounds like there is some time, yet, for manufacturers to overcome their fears of XML.
[Hat tip to Eisner Safety]
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