北京市促进临床急需药械临时进口，建立绿色通道

为促进北京市临床急需药品和医疗器械的进口、建立审批绿色通道，北京市药监局于8月7日发布了《北京市促进临床急需药械临时进口工作实施方案（试行）》（征求意见稿）（以下简称“方案”），向社会公开征求意见。意见反馈截止日期为 8月13日。

 《方案》强调四项重点任务和两项保障措施。重点任务包括：

• 一是由北京市卫健委负责指导医疗机构申请临床急需药械，同时建立相应的收集和指导机制。

• 二是北京市药监局和北京市卫健委在国家相关部门指导下，开展提前评估，形成联合评估机制。

• 三是简化非首次进口评估程序，提高审批效率。

• 四是提升通关便利化，允许医疗机构分批申请通关文件，由北京海关加快办理通关文件。

作为保障措施，《方案》提出建立联席工作机制，由北京市药监局定期召集北京市卫健委、北京海关和北京市医保局召开联席会议；各部门要主动满足患者需求，支持临床急需药械及创新产品在北京上市，并纳入普惠险，以减轻患者负担。

自2018年国务院加快境外已上市新药上市审批、简化临床急需药品上市要求以来，北京市药监局采取了多项措施，支持临床急需药品进口：在天竺设立分局及专门的药品通关窗口，提供24小时不间断服务，特别针对抗癌药、罕见病药等境外急需药品实施快速通关。

2024年上半年，北京地区医药材及药品进口总额达到645.6亿元，居全国首位。其中，罕见病药品进口额为14.4亿元，占全国罕见病药品进口总额的46.4%。北京天竺罕见病药品保障先行区建设成效显著。今年上半年，天竺罕见病药品进口额达12.9亿元，增长15.5%，占同期北京罕见病药品进口总额的89.8%。

《方案》的最终发布实施将进一步促进北京尤其是天竺先行区药品进口，满足临床需求，惠及广大罕见病、癌症患者。

On August 7, the Beijing Municipal Medical Products Administration (BMMPA) issued the draft Implementation Plan for Promoting Temporary Import of Urgently Needed Drugs and Devices in Clinical Settings (draft for comments) (“Trial Plan”) to promote the import of urgently needed drugs and medical devices in Beijing and establish a dedicated green channel for their approval. The call for comments closed on August 13. 

The Trial Plan outlines four key tasks: 

• First, the Beijing Municipal Medical Insurance Bureau (BMMIB) will establish the procedures for submitting and collecting applications for urgent drug imports and will guide medical institutions in the submission process. 

• Second, a joint assessment mechanism will be established between national and municipal health and drug regulators to conduct preliminary evaluations of medical institutions' needs. 

• Third, authorities will simplify the assessment procedure for non-first-time or follow-up import applications to expedite approval. 

• Fourth, medical institutions can submit bulk import applications, and the Beijing Customs District (BCD) will expedite the customs clearance process for these items.  

The Trial Plan proposes that the BMMPA regularly convene with the BMHC, BCD, and Beijing Medical Insurance Bureau (BMICB) and establish a joint working mechanism among these departments. The plan specifically emphasises that government departments at all levels should proactively address patient needs by supporting the import of drugs and devices urgently needed in Beijing, promoting the marketing registration of innovative products, and exploring ways to alleviate patients’ financial burdens, such as through commercial health insurance (CHI).

In 2018, the State Council expedited the marketing registration of overseas new drugs and simplified applications for urgently needed drugs. Since then, BMMPA has taken several steps to support the import of urgently needed drugs by opening a branch and special drug clearance window in Tianzhu comprehensive Free Trade Zone, providing 24-hour service, and expediting customs clearances for urgently needed drugs, especially for cancer and rare disease treatments.

During the first half of 2024, Beijing imported CNY 64.56 billion worth of medicinal materials and drugs, the highest in China. Of this total, CNY 1.44 billion was for rare disease drugs, representing 46.4 percent of China's rare disease drug imports. 

Beijing's implementation of a pilot zone for rare disease drugs further boosted Tianzhu’s imports. In the first half of the year, rare disease drugs imported through Tianzhu reached CNY 1.29 billion, marking a 15.5 percent increase compared to the same period last year and representing 89.8 percent of Beijing's total rare disease drug imports.

The final release of the Trial Plan will add new momentum to Beijing’s drug imports and promote patient access to much-needed rare diseases drugs.