Japan and eCTD: What We Know
Mar29

Japan and eCTD: What We Know

Japan’s Pharmaceutical and Medical Devices Agency (PMDA), one of the earliest adopters of eCTD, adheres to a number of unique business rules which create a unique implementation of the eCTD specifications. Information available on eCTD best practices is also limited for this region, primarily due to lower levels of submission activity. What do we already know about submitting eCTDs in Japan and what can we expect later this decade as they implement eCTD v4.0?

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ICH Working Group Making Progress on Next Major Version of eCTD

Last week I was at the ICH meeting in Japan. If you haven’t been to Japan, I highly recommend a visit to this beautiful country and its very friendly people. We had a productive meeting. My time was split between working on eCTD and ICSR. The eCTD group focused on change requests and requirements for the next major version. While there were no significant changes made, we are working hard to include Module 3 Q&A as soon as...

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Japan Presentation Compares eCTD to RPS

I was not able to attend the HL7 Working Group meeting in Japan last week, but I did give an RPS education session remotely. The agenda including the background of RPS, the foundation of the standard, document lifecycle, release two of the standard and a comparison of RPS to eCTD. In the background section we discussed the goal, scope, how the project was initiated and the project’s acomplishments. In the foundation section we...

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Top 10 Validation Errors for Health Canada

  The AAPS Workshop on Strategic Management of CMC Dossiers in the eCTD Format: What CMC Professionals Need to Know Now! was held March 9-11, 2009. There were some great presentations, and best of all they are publically available. The agenda contains links to the presentations. All the presentations were good but some of the highlights for me appear below. There’s great information on Japan and Health Canada that has been rather...

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Updates on eCTD Specification in Europe, Japan

EMEA and PMDA provided an update on eCTD status at the traditional “Update on Regulatory Authority Experience” session. Tim Buxton was the speaker from EMEA. He provided the following statistics on eCTDs received between July and December 2007: Centralised Procedure: 14 new applications, 80 variations National Procedures (as reported by national compentent authorities): 659 new applications, 611 variations Mr. Buxton also...

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