The Urgent Use Program is a unique initiative implemented by the Chinese government in the Hainan province, one of the free trade zones in China. This program is designed to expedite the approval process for innovative medical devices and pharmaceuticals that are urgently needed for clinical use, even if they have not yet received market approval in China.
Urgent Use Program in Hainan
Objective: The program aims to provide timely access to innovative medical devices and drugs that address unmet clinical needs, particularly for life-threatening diseases with no effective treatment available.
Eligibility: The Urgent Use Program mainly targets innovative products that have received market approval in the US, EU, or Japan but are still awaiting approval by China’s National Medical Products Administration (NMPA).
Process: Once a product is listed under the Urgent Use Program, it can be used in designated hospitals in Hainan province. This allows healthcare providers to use these products for patients in need, while also generating real-world data that can potentially support the product’s full market approval process in China.
Benefits: The program not only accelerates access to innovative treatments for patients in need, but also provides medical device companies with a unique pathway to introduce their products to the Chinese market. By participating in this program, companies can gather real-world data and gain invaluable first-hand experience in China’s healthcare landscape.
Remember, while the Urgent Use Program offers a promising opportunity, it requires careful navigation given its unique nature and stringent regulations. We can provide support and expertise to guide your company through this process, ensuring your products reach patients in need as swiftly and efficiently as possible.