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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eCTD Adoption Among Major Reforms Underway in China Pharmaceutical Market
Jan21

eCTD Adoption Among Major Reforms Underway in China Pharmaceutical Market

If history is any indication, the China Food and Drug Administration’s (CFDA) adoption of eCTD will also outpace anything previously seen at other regional health agencies. Moving to eCTD submissions is just one of many initiatives currently underway in China as part of an effort to reform regulation of the pharmaceutical industry.

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FDA New Module 1 Implementation Delayed Until Q2 2014

The new US eCTD Module 1 first appeared on the Federal Register (FR) docket in October 2011. After the required comment period, a final version appeared in 2012 and a public meeting was held. Currently, the stated timeline to accept submissions containing the new Module 1 is September 2013. While the FDA has made significant progress on Module 1, we anticipate the announcement of a revised timeline later this summer. Why is this...

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Drug Development Costs Rise to $1.3 Billion

The cost of bringing a new drug to market is often cited as $1.3B according to a Tufts University study from several years ago. In this study, the $1.3B estimate is an increase of 60% from the previous estimate of $800M. Much of the cost associated with drug development is attributed to resources invested in drugs that never make it to market. Only one out of 10 drugs that are used as part of a clinical trial will become a marketed...

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Simultaneous eCTD Submissions to Multiple Regions

Traditionally, a pharmaceutical company would seek to have a drug approved in one region, and then move to other regions around the world to seek approval. Typically, companies would seek approval in their country of origin, then pursue the biggest markets, and finally focus on the rest of the world. The advent of CTD provided a common organizational structure to create submissions around the world. The ability to reuse large parts of...

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