2024年以来，北京市天竺综合保税区新增了24个药品品种进口，园区药品进口规模全国领先。去年年底以来，天竺综保区积极推动探索形成了罕见病药品保障先行区，推出创新性的"白名单"制度，进一步打通了未注册罕见病药品的市场准入壁垒。

中国美国商会会员企业高度重视天竺综合保税区的药械申报准入政策，以及园区内投资发展机会。因此，中国美国商会计划于 12 月 30日举办与北京市天竺综合保税区座谈交流会。我们很荣幸邀请到天竺综合保税区领导分享有关天竺开发区的罕见病药品备货，申报国际上市而国内未上市药品的临床应用渠道，未来是否会扩展其他药品、器械、设备、耗材"先行先试"，以及外资诊所相关政策。此外，北京市药品监督管理局领导也将出席并对药品申报与审批路径进行政策解读。

请参与本次圆桌讨论会的企业提前准备好贵司在药品、器械等申报和审批领域的诉求或者感兴趣的政策话题，以便于更高效地开展线下交流。

活动信息

• 会议形式： 仅线下
• 时间地点：12月30日，星期一 （具体时间待定），北京市顺义区天竺综合保税区（具体会址待定）
• 语言：中文
• 联系人：Xi Wang, xwang@amchamchina.org

Since 2024, the Beijing Tianzhu Comprehensive Bonded Zone has introduced 24 new drug varieties for import, making its pharmaceutical import volume the leading one nationwide. Since the end of last year, the Tianzhu Comprehensive Bonded Zone has actively explored and developed a pioneering initiative to ensure access to medications for rare diseases. This includes introducing an innovative "whitelist" system, which further breaks down market access barriers for unregistered rare disease drugs.

AmCham China member companies highly value the drug and device registration and access policies of the Tianzhu Comprehensive Bonded Zone, as well as the investment and development opportunities within the zone. Therefore, AmCham China plans to host a roundtable discussion with the Beijing Tianzhu Comprehensive Bonded Zone on December 30. We are honored to invite officials from the Tianzhu Comprehensive Bonded Zone to share insights on the stocking of rare disease drugs, clinical application channels for drugs registered internationally but not yet domestically, potential future expansions to include other drugs, medical devices, equipment, and consumables under pilot programs, as well as policies related to foreign-funded clinics. Additionally, officials from the Beijing Municipal Medical Products Administration will attend to provide policy interpretations on drug registration and approval pathways.

We kindly request participating companies to prepare in advance any specific needs or topics of interest regarding drug and medical device registration and approval. This will facilitate more efficient and productive in-person exchanges during the roundtable discussion.

Event Details

• Event format: In-person
• Time & Date: December 30th, Monday (TBD), the Beijing Tianzhu Comprehensive Bonded Zone (TBD)
• Language: Chinese
• Contact: Xi Wang, xwang@amchamchina.org