What Good is eCTD If It’s Not Global?

We cover a lot about eCTD here at Applied Clinical Trials. This is because it is an emerging and large-scale global initiative that has the potential to transform the clinical trial submission process for the better.

But what advantages are there to eCTD if it doesn’t fulfill its intended benefits of being a globalized standard for submissions?

Clearly getting the entire world on the same page with regulatory submissions is a long-term task, one that does not hold any guarantee for success. So far, however, the United States, European Union, Japan, and Canada have adopted the eCTD format.

“Ten years ago when sponsor’s looked to market their product globally, they would need to compile their applications individually according to each country’s specific format. Now, with CTD and eCTD, they’re minimizing the rework for at least 6-10 countries. That’s a huge time and cost savings,” noted Michelle Perez, Principal Consultant of Regulatory Consulting Services at ISI.

But what about those countries that have not embraced eCTD?

“We find globally that they’re accepting [eCTD submissions], but they’re not necessarily looking at them,” Carol Rutkowski, senior director of global regulatory operations for Shire Pharmaceuticals, noted at a roundtable discussion of early eCTD adopters that Applied Clinical Trials covered back in March.

“We sent out about a half dozen applications and have not heard back,” added Albert Edwards, PharmD, RAC, the director of regulatory operations for Takeda Global Research & Development Center, and also a member of the roundtable discussion. “We are taking it as a good sign,” he joked.

While eCTD may make the submission process easier within the countries that have adopted it, there still exists global barriers to drug development due to regulatory agencies only responding to their domestic submission format.

With the intention to make the submission process easier for all stakeholders, why wouldn’t all regions want to jump on board?

“Looking at the major emerging regions (Latin America, Brazil, Russia, India, China, The Association of Southeast Asian countries, and countries of the former Soviet Republic), each country involved is in agreement in principle with adopting the concept of global harmonization,” said Perez. “However, making that transition and changing regulations that fit the scope of that transition is a huge undertaking.”

Perez pointed to technical infrastructure and an overall lack of submission rules and laws as major challenges that many countries yet to implement eCTD face.

Some countries have gone on to implement their own electronic format, like Venezuela and its eFormat, which was introduced in October of 2008. While Perez told us that this new requirement makes sense in regards to the countries’ review challenges, she also noted that it would make the transition to eCTD that much harder.

Another stumbling block is when countries implement CTD, but not eCTD. “One thing that makes it difficult in Europe, they’re using CTD, but not necessarily electronic. They think they’re using CTD, but you change to electronic and it’s completely different,” explained Mike McGraw, manager of regulatory affairs for Teva Neuroscience, who was also present at the roundtable discussion.

For the undertaking that eCTD is, there has been a successful amount of progress. But, maybe a global push isn’t enough. Is it time that the eCTD-adopted regions begin to only accept these types of format?