USFDA's eCTD 4.0 Update: Key Takeaways

The regulatory landscape has been abuzz with anticipation for the USFDA's update on eCTD v4.0. Regulatory professionals and life sciences companies have been eagerly awaiting news on the next steps for this critical submission format. Finally, a few months ago, the USFDA announced that, starting from September 16, 2024, they would support the electronic submission of eCTD v4.0 for new applications.

Paperless Regulatory Submissions in China - A Big Market Opportunity

China’s pharmaceutical industry has seen substantial growth since its entry into the World Trade Organization (WTO). As of 2021, China holds a 12% share of the global pharmaceutical market, making it the second largest contributor. According to Xinhua News Agency, the Chinese pharmaceuticals market generated 708.75 billion yuan in 2021, while the Chinese domestic medicinal companies amassed 502 billion USD in profit.