京药监发〔2026〕147号 — Policy dissemination

Country-interest evidence · pilot

Trade inferences use UN Comtrade, with China as reporter. Country connections indicate potential trade relevance, not measured harm, firm-level exposure or legal applicability. Inward measures concern exporters to China; competition with Chinese exports in third markets is not assessed.

Inspect implementing jurisdictions and partner evidence · 48 relationships

Argentina: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 50904 · recorded trade USD 44,821,220

Australia: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 50904 · recorded trade USD 190,772,765

Austria: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 50904 · recorded trade USD 1,044,775,913

Belgium: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 50904 · recorded trade USD 777,232,606

Bulgaria: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 50904 · recorded trade USD 6,249,157

Brazil: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 50904 · recorded trade USD 35,795,239

Canada: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 50904 · recorded trade USD 390,698,824

Switzerland: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 50904 · recorded trade USD 3,589,655,743

Cyprus: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 50904 · recorded trade USD 1,767,752

Czech Republic: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 50904 · recorded trade USD 1,406,293

Germany: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 50904 · recorded trade USD 6,195,588,545

Denmark: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 50904 · recorded trade USD 1,370,004,064

Spain: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 50904 · recorded trade USD 775,419,753

Finland: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 50904 · recorded trade USD 224,379,331

France: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 50904 · recorded trade USD 2,477,967,868

United Kingdom: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 50904 · recorded trade USD 945,928,200

Greece: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 50904 · recorded trade USD 318,901,689

Hong Kong, China: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 50904 · recorded trade USD 516,823,625

Croatia: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 50904 · recorded trade USD 4,553,038

Hungary: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 50904 · recorded trade USD 69,391,077

Indonesia: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 50904 · recorded trade USD 3,796,846

India: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 50904 · recorded trade USD 132,571,994

Ireland: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 50904 · recorded trade USD 4,958,676,527

Israel: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 50904 · recorded trade USD 27,077,390

Italy: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 50904 · recorded trade USD 3,286,190,246

Japan: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 50904 · recorded trade USD 1,987,698,872

Korea, Rep.: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 50904 · recorded trade USD 151,744,054

Lithuania: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 50904 · recorded trade USD 4,510,422

Mexico: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 50904 · recorded trade USD 3,560,612

Netherlands: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 50904 · recorded trade USD 622,460,583

Norway: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 50904 · recorded trade USD 22,769,898

New Zealand: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 50904 · recorded trade USD 21,823,619

Poland: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 50904 · recorded trade USD 61,269,217

Portugal: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 50904 · recorded trade USD 8,485,589

Romania: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 50904 · recorded trade USD 15,509,416

Russian Federation: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 50904 · recorded trade USD 1,666,759

Singapore: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 50904 · recorded trade USD 139,364,769

Slovak Republic: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 50904 · recorded trade USD 1,402,342

Slovenia: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 50904 · recorded trade USD 205,907,646

Sweden: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 50904 · recorded trade USD 1,988,941,999

Thailand: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 50904 · recorded trade USD 14,075,515

Turkey: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 50904 · recorded trade USD 10,464,822

Chinese Taipei: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 50904 · recorded trade USD 230,161,489

Uruguay: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 50904 · recorded trade USD 14,508,770

United States: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 50904 · recorded trade USD 5,837,763,637

Vietnam: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 50904 · recorded trade USD 3,376,037

South Africa: Trade-based inference; exporters to China; summed product trade > USD 1m; 2025 trade; broad sector headings; computed, not analyst-reviewed · intervention 50904 · recorded trade USD 18,223,586

Implementing jurisdiction: China · intervention 50904

Assessment states

Trade-based partners recorded

Measures

Local registration condition

Provincial · locality: Local firms · CPC 352 · in force from 2026-07-31 · until 2026-12-31 · Keyword screen (unreviewed)

Implemented by China (subnational) · affects 47 partners (inferred from trade data, 2025 trade): Germany, United States, Ireland, Switzerland, Italy, France …

申请单位应为本市注册的生物医药企业（研发机构），且为报关单实际收货人或者消费使用单位。

Asymmetric provisions

Local registration / tax (本地注册, 纳税)

Disadvantages: firms from other regions · Keyword screen (unreviewed)

申请单位应为本市注册的生物医药企业（研发机构），且为报关单实际收货人或者消费使用单位。

Full text

京药监发〔2026〕 147 号北京经济技术开发区管委会，各区科技主管部门、经济和信息化主管部门、商务主管部门、市场监管部门、各隶属海关，市药品监督管理局各分局，各有关单位：为进一步激发我市生物医药产业创新活力，在总结生物医药研发用物品进口试点工作经验基础上，依托国家服务业扩大开放综合示范区和自由贸易试验区，持续服务我市生物医药领域研发用物品进口工作，支持我市生物医药企业（研发机构）开展创新产品研发，现将《北京市生物医药研发用物品进口工作方案》印发给你们，请遵照执行。特此通知。北京市药品监督管理局北京市科学技术委员会、中关村科技园区管理委员会（北京市科学技术委员会代章）北京市经济和信息化局北京市商务局中华人民共和国北京海关 2026年7月30日北京市生物医药研发用物品进口工作方案为激发我市生物医药产业创新活力，依托国家服务业扩大开放综合示范区和自由贸易试验区，打造具有全球影响力的医药产业创新高地，推动本市生物医药产业高质量发展迈上更高台阶，根据《中国(北京)自由贸易试验区条例》《北京市生物医药全产业链开放实施方案》，制定本方案。一、工作目标根据“协同创新、便利通关、风险联控”的原则，开展生物医药领域研发用物品进口便利通关工作，建立本市生物医药企业（研发机构）进口研发用物品“白名单”（以下简称“白名单”）制度，对于纳入“白名单”的物品进口，申请单位无需申领《进口药品通关单》，进一步提升进口便利化。二、适用范围 “白名单”由申请单位和进口物品两部分组成，申请单位与进口物品需要一一对应。申请单位应为本市注册的生物医药企业（研发机构），且为报关单实际收货人或者消费使用单位。申请单位应当具备与研发工作相匹配的研发能力，负责所进口物品在研发过程中的科学、合理、安全使用，具有对进口物品全流程追溯的能力；具备良好的信用记录，进口申请前两年内无违法违规和严重失信记录。进口物品范围为生物医药企业（研发机构）研发过程中，作为临床前研究、过程物料或者辅料但未在国内外按照药品批准规定上市销售的物品，因商品编号列入《进口药品目录》范围，但不符合《药品进口管理办法》（国家食品药品监督管理局、海关总署令2003年第4号）规定的情形，无法取得《进口药品通关单》导致无法通关放行。进口物品不包含列入国家禁止和限制进口的物品，以及麻醉药品、精神药品、放射性产品及易制毒化学品。对属于《药品进口管理办法》规定情形的物品、符合一次性进口办理条件的物品，仍需按照法定程序办理进口备案手续。进口物品仅限申请单位在本市范围内开展研发自用，不得用于临床试验、销售、赠与、交换等其他用途。三、工作机制（一）建立本市“白名单”制度联合推进机制建立由市药监局牵头，市科委中关村管委会、北京海关、市商务局、市经济和信息化局共同参与的本市“白名单”制度联合推进机制，加强部门联动，整合资源要素，形成工作合力。联合推进机制办公室设在市药监局。（二）“白名单”的认定 1.本市企业（研发机构）按“白名单”申请资料要求和办理程序（见附件）向联合推进机制办公室提出进口申请。联合推进机制办公室向相关责任部门分派“白名单”的认定任务。 2.市科委中关村管委会负责“白名单”申请单位研发条件和追溯能力的认定工作，必要时可组织申请单位属地科技主管部门和专家参与认定。 3.市药监局负责“白名单”物品的属性认定工作，必要时组织专家参与认定。（三）“白名单”的发布 “白名单”的认定工作完成后，由联合推进机制办公室汇总，经联合推进机制成员单位共同确定，由五部门联合向社会即时公布并动态调整。同一申请单位再次进口相同物品时，对于研发用途和进口物品属性均与前次申请一致的，申请人在提交进口申请后，联合推进机制成员单位免于认定，由五部门联合向社会直接公布。“白名单”自公布之日起有效期12个月，申请单位应在有效期内办理通关手续，有效期限届满后，申请单位需重新提出申请。（四）便利化通关对纳入“白名单”的申请单位和进口物品，申请单位应当在有效期内向北京海关申报进口。在北京口岸进口时，申请单位无需申领《进口药品通关单》即可办理通关手续。（五）事中事后监管研发结束后，申请单位应当将未使用的“白名单”物品做无害化处理，并在研发结束后1个月内向联合推进机制办公室报告“白名单”物品使用情况和无害化处理情况。进口物品的台账、无害化处理记录等体现物品实际流向的原始管理记录资料，自研发项目结束之日起应当至少保存5年，法律法规规章规定资料档案保管时限超过5年的，按照法律法规规章相关规定执行。市商务局负责牵头，定期组织市区两级相关部门开展“白名单”物品使用情况的检查工作，形成闭环管理。如发现违规行为，将申请单位和进口物品移出“白名单”，两年内不再接受申请单位“白名单”申请。加强信用监管，提升监管效能，违法违规信息按本市有关规定纳入企业信用记录。涉及刑事犯罪的，将移送司法机关依法处理。四、保障措施（一）强化统筹协调市药监局、市科委中关村管委会、北京海关、市商务局、市经济和信息化局建立“白名单”联席会议制度，定期召开联席会议，协调、统筹、推进“白名单”评价工作，加强信息互通，及时通报进展，协调解决工作中出现的问题。（二）强化申请单位主体责任申请单位应当具备对进口物品的全流程追溯能力、风险防控和处置能力，严格按照申请用途开展研发工作，负责所进口物品的科学、合理、安全使用，防止流弊。申请单位应当建立进口物品采购、储存、使用以及处置台账，并接受进口物品全流程监管。（三）强化主动服务市药监局负责牵头，组织开展“白名单”制度的宣传指导，积极开展政策宣讲等相关工作。市经济和信息化局负责通过走访和集中座谈等方式，深入企业（研发机构）调研，多渠道收集企业（研发机构）需求，进一步完善和优化“白名单”制度。五、其他事项（一）关于生物医药领域研发用物品进口，国家另有规定的,从其规定。（二）本方案自发布之日起实施。《北京市生物医药研发用物品进口试点方案》（京药监发〔2022〕166号）实施期间发布的进口物品“白名单”有效期至2026年12月31日。附件 “白名单”申请资料要求和办理程序一、申请资料要求 1.申请表（附后）。 2.申请单位机构合法登记证明文件复印件（限首次申请）。 3.申请报告。内容应包括：拟申请进口物品的来源、具体用途、数量、使用计划；申请单位的研发条件（限首次申请）、使用管理（限首次申请）、追溯能力（限首次申请）、风险防控措施等情况说明和管理文件复印件。 4.承诺书（附后）。申请单位书面承诺所进口物品不得用于临床、上市销售、赠与、交换及申请用途以外的其他用途等内容。 5.拟进口物品的国外获准证明材料（如有）。 6.原产地证明复印件（如有）。 7.货物合同复印件。 8.其他认为需提交的材料。非首次申请应说明有关资料文件较上一次申请时是否发生变更并列明具体变更内容。已发生重大变更的，应补充提交变更后的资料文件。二、办理程序 1.符合范围的申请单位，按申请资料要求准备资料，向联合推进机制办公室（咨询电话：010-55526915）提出进口研发用物品的申请。 2.市科委中关村管委会应当在接到认定任务后10个工作日内完成“白名单”申请单位研发条件和追溯能力的认定；市药监局应当在接到认定任务后10个工作日内完成“白名单”物品的属性认定。 3.符合“白名单”要求的，即时向社会公布并动态调整；不符合要求的，书面告知申请单位。 4.对纳入“白名单”的物品，申请单位无需申领《进口药品通关单》，由北京海关办理通关手续。 “白名单”申请表承诺书本单位郑重声明：我单位保证申请资料和提交的证明材料真实、完整、准确，翻译件、复印件内容与原件内容一致。所申请进口物品仅供本单位研发使用，不用于临床、上市销售、赠与、交换及申请用途以外的其他用途。如违反本承诺，我单位将承担相应法律责任及由此造成的一切后果。法定代表人（签字）单位（公章）年月日

Ask the evidence.

北京市药品监督管理局等单位关于印发《北京市生物医药研发用物品进口工作方案》的通知

Country-interest evidence · pilot

Measures

Asymmetric provisions

Full text