Pharmaceutical Research and Manufacturers of America (PhRMA), the trade federation representing the US pharma industry, has called out several countries for failing to uphold data exclusivity and live by international trade obligations.
While China has agreed to uphold a six year period of regulatory data protection (RDP) under World Trade Organization rules, PhRMA says that in practice the country’s policies are “ambiguous, inconsistent, and unevenly applied.”
As a result, “China’s regulatory environment provides an unfair advantage to competing firms to freeload off our safety and efficacy data.”
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