药械产业出海
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上海22条新政赋能创新药械,入院周期、产品出海全面提速
Di Yi Cai Jing· 2025-11-26 12:29
Core Viewpoint - Shanghai is implementing a series of measures to enhance the efficiency of the approval and application processes for innovative drugs and medical devices, aiming to reduce the hospital admission process for critical new drugs from 30 days to 15 days [1][2]. Group 1: Policy Measures - The newly issued "Several Measures" includes six areas with a total of 22 items aimed at promoting the development of the pharmaceutical and medical device industry through regulatory reforms [1][2]. - Key areas of focus include supporting research and development innovation, enhancing review and approval efficiency, expanding high-level open cooperation, and constructing a full lifecycle regulatory framework [2][4]. Group 2: Innovation Acceleration - The measures emphasize accelerating the application of innovative products by optimizing the listing services for new drugs and exploring efficient mechanisms for the transition from research to application [2][3]. - Shanghai aims to become the first province to list new innovative drugs, which could serve as a reference for other regions [3]. Group 3: Internationalization and Standards - The measures propose to align with international standards to facilitate the export of domestic pharmaceutical and medical device products, including supporting international clinical trials and enhancing the recognition of domestic testing institutions [5][6]. - The importance of addressing regulatory challenges faced by companies during international expansion is highlighted, with a focus on improving service levels and introducing high-quality overseas resources [6].
深圳成立首个药械产业出海联合体
news flash· 2025-05-24 23:39
Core Insights - The establishment of Shenzhen's first pharmaceutical and medical device industry overseas joint venture aims to connect local companies with global markets, enhancing export capabilities [1] - Shenzhen is a leader in high-end medical device exports, with significant metrics ranking it among the top in the country [1] - In 2024, Shenzhen's pharmaceutical and medical device industry is projected to have the highest export total among major cities, accounting for 12.9% of the national total [1] Group 1 - The joint venture consists of manufacturers, professional service institutions, and industry associations [1] - The initiative is part of Shenzhen's "Double Hundred Action" to accelerate the overseas expansion of its pharmaceutical and medical device sectors [1] - The joint venture aims to create an accelerator for local pharmaceutical and medical device companies to explore international markets [1] Group 2 - Shenzhen's performance in the high-end medical device export sector is highlighted as particularly strong [1] - The city's export total for the pharmaceutical and medical device industry is expected to lead among major cities in 2024 [1] - The national export share of Shenzhen's pharmaceutical and medical device industry is projected to be 12.9% [1]
深圳成立首个药械产业出海联合体 助力企业“借船出海”“抱团出海”
Shen Zhen Shang Bao· 2025-05-24 17:42
Core Insights - Shenzhen has established its first pharmaceutical and medical device industry overseas joint venture to enhance global market access and accelerate the internationalization of local enterprises [1][2] Group 1: Industry Overview - Shenzhen's pharmaceutical and medical device exports are projected to lead major cities in China in 2024, accounting for 12.9% of the national total [1] - The total export value of medical devices from Shenzhen reached 29.8 billion yuan, with a year-on-year growth of 12.3%, representing 21.3% of the national export share [1] - Pharmaceutical exports from Shenzhen totaled 11.5 billion yuan, with a continuous increase in national share, reaching 6.4% in 2024 [1] Group 2: Joint Venture Structure - The joint venture is initiated by leading companies such as Kexing Pharmaceutical and Mindray Medical, along with other prominent firms like Health元 and Haipru [2] - It includes collaboration with professional service institutions in insurance, consulting, legal, and logistics sectors to create a comprehensive support ecosystem for overseas expansion [2] - The joint venture will establish specialized committees for pharmaceutical and medical device exports, facilitating access to international resources and market entry [2] Group 3: Future Initiatives - The joint venture plans to conduct a series of activities including brand promotion, training, and participation in international exhibitions to showcase Shenzhen's pharmaceutical and medical device innovations [2] - It aims to organize training on legal regulations, product registration, and market analysis, enhancing the capabilities of local enterprises for international operations [2] - The initiative will focus on collective participation in international exhibitions across regions such as Europe, South America, and Central Asia to enhance the global visibility of Shenzhen's pharmaceutical and medical device industry [2]