,Are New US-China Data Rules Putting Your Regulatory Submissions at Risk?
Recent changes in international data-sharing regulations could create significant roadblocks for your Regulatory Submissions and derail your product's journey to market. Since the U.S. Department of Justice announced stricter rules on December 27, 2024, regarding information exchange with China and other nations, life sciences companies face new, complex challenges in managing sensitive patient and clinical data.
Navigating these cross-border data transfer regulations is now critical for timely and successful regulatory approvals.
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What's at Stake?
For companies reliant on US-China data sharing or cross-border partnerships, failing to adapt to these new pharmaceutical data compliance rules can have severe consequences. Your organization could face:
Critical Delays and Rejections
A non-compliant submission or a missed deadline can lead to outright rejection from health authorities, delaying your product’s approval by months or even years.
Severe Fines and Penalties
Failure to comply with clinical data regulations can result in substantial financial penalties and increased regulatory scrutiny, jeopardizing your financial stability.
Loss of Market Access
A failure to meet current eCTD publishing and data security standards could result in the denial of market approval in key regions like the United States and Europe.
Brand Reputation Damage
A mishandled submission involving sensitive data can inflict lasting damage on your company’s reputation and stakeholder trust.
Why Global Life Sciences Leaders Trust Freyr
Freyr's regulatory publishing experts specialize in managing complex US-China data sharing restrictions, ensuring your submissions are secure and compliant. We partner with leading pharmaceutical firms in the US, EU, and Japan, providing expert consultation and seamless eCTD 4.0 adoption.
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