MEDTECH NEWS

China Beijing has announced a new initiative to streamline the import process for urgently needed drugs and medical devices on September 20, 2024. The Beijing Municipal Medical Products Administration, along with three other departments, has issued a trial implementation plan to create a "green channel" for the temporary import of clinically urgent medications and medical equipment.

China's National Medical Products Administration, in collaboration with the National Health Commission, has implemented regulations for the temporary import and use of essential medical devices in response to urgent clinical needs. The guidelines prioritize public health, outlining responsibilities, application processes, and usage requirements for medical institutions. The directive targets second and third-class medical devices unavailable domestically for critical life-saving treatments. Furthermore, the initiative ensures adherence to quality standards and patient safety in leading medical institutions. Ongoing support and training initiatives are planned to address specific medical needs effectively.

The Guangdong Provincial Drug Administration has launched the "Guangdong-Hong Kong-Macao Greater Bay Area (GBA) Medical Pass," a pioneering policy initiative aimed at enhancing real-world medical research within the region. This policy facilitates the use of cutting-edge, clinically urgent medical products in designated institutions, thereby accelerating the approval processes and integrating real-world evidence into regulatory assessments. The initiative was highlighted through the introduction of the PROEM study at a conference in Guangzhou, focusing on the real-world efficacy and safety of Lemborexant in treating insomnia. The robust biopharmaceutical infrastructure in Guangdong supports a range from basic research to clinical applications, underpinning the region's leadership in drug and medical device innovation. As of March 2024, significant progress has been made with 19 institutions approved to participate and 59 types of medical products sanctioned for use, benefiting over 5,000 patients. Looking forward, Guangdong aims to further consolidate its role as a global biopharmaceutical hub by leveraging its industrial strengths and integrating resources across the GBA. This initiative not only underscores the region's commitment to scientific advancement and patient care but also sets a precedent for regulatory innovation in medical research across China.

Xiong'an New Area introduces comprehensive measures to support the life sciences and biotechnology sectors, including financial incentives for the industrialization of medical devices, support for international registration and certification of drugs and devices, subsidies for public service platform establishment, encouragement of special medical food industry development, and promotion of pharmaceutical clinical application and research, aiming to foster innovation and position the area as a leading hub in these fields.