Declaring psychotropic drug imports and exports: NMPA-GACC Announcement 2026 No. 84

2026-09-03 Healthcare & Pharma / 医药医疗

• The National Medical Products Administration (NMPA) and the General Administration of Customs (GACC) jointly published Announcement 2026 No. 84 on 28 August 2026, providing the customs HS commodity numbers to reference when declaring import or export of newly controlled medicinal psychotropic substances.
  2026年8月28日，国家药监局与海关总署联合发布2026年第84号公告，就新列入管制范围的药用类精神药品的进出口申报，公布供通关申报参考的海关商品编号。

• The announcement follows a separate joint decision by NMPA, the Ministry of Public Security and the National Health Commission adding three substances to the medicinal psychotropic substance catalogue: methoxyetomidate, leretomidate and sonanfetomide — with exceptions for drug preparations approved for marketing in China.
  公告之前，国家药监局、公安部、国家卫生健康委联合发布调整公告，将甲氧依托咪酯、乐瑞托咪酯、索安非托增列入药用类精神药品目录（在中国境内批准上市的相应药品制剂除外）。

• The published commodity numbers cover only part of the controlled goods; importers and exporters whose actual goods fall outside the listed numbers must declare truthfully rather than assume exemption.
  公布的编号仅包含管制商品中的部分商品；实际进出口商品超出相关商品编号范围的，应当如实申报，而非推定不涉管制。

• The rules anchor to the Drug Administration Law and the Customs Law: medicinal psychotropic substances remain subject to import/export permit and reporting disciplines administered by NMPA and customs.
  新规以《药品管理法》《海关法》为法律依据：药用类精神药品进出口仍适用由国家药监局与海关管理的准许证与申报纪律。

• The announcement takes effect on 1 October 2026, giving pharmaceutical importers, exporters and CRO/logistics partners a one-month window to update screening and declaration procedures.
  公告自2026年10月1日起施行，为医药进出口企业、研发外包与物流伙伴留下约一个月时间更新筛查与申报流程。

• For pharmaceutical companies shipping controlled APIs or finished drugs in or out of China, the practical task is to verify each SKU against the expanded catalogue and the new commodity numbers, and to keep records showing the actual substance and formulation status.
  对进出境受管制原料药或制剂的企业而言，实操要点是逐一核对产品品目是否落入扩围后的目录与新商品编号，并留存能证明实际物质与制剂状态的记录。

Declaring psychotropic drug imports and exports: NMPA-GACC Announcement 2026 No. 84 | 药用类精神药品进出口申报新规：国家药监局 海关总署2026年第84号公告解读

Overview

On 28 August 2026 the National Medical Products Administration (NMPA) and the General Administration of Customs (GACC) published Announcement 2026 No. 84 — Matters Concerning the Declaration of Import and Export of Medicinal Psychotropic Substances (国家药监局 海关总署关于药用类精神药品进出口申报事项的公告). The announcement sets out the customs HS commodity numbers to reference when declaring imports or exports of varieties that were recently added to the medicinal psychotropic substance catalogue, and takes effect on 1 October 2026.

The announcement sits on top of an earlier regulatory step: NMPA, the Ministry of Public Security and the National Health Commission jointly issued a decision adjusting the medicinal psychotropic substance catalogue, adding methoxyetomidate, leretomidate and sonanfetomide to the list — except for drug preparations containing these substances that have been approved for marketing in China. Announcement 2026 No. 84 was then issued under the Drug Administration Law and the Customs Law to give traders concrete reference numbers for customs declaration.

Why this matters

China exercises strict control over psychotropic substances under its drug-control system, and the import and export of such substances requires permits and compliant declaration. The significance of this announcement is twofold:

1. The control scope just widened. Three substances — methoxyetomidate, leretomidate and sonanfetomide — have been added to the medicinal psychotropic substance catalogue. Any company shipping these substances into or out of China (outside the China-approved formulation carve-out) now falls within the controlled-substance regime.
2. Customs now has published reference codes. By giving HS commodity numbers for the newly added varieties, NMPA and GACC intend to reduce ambiguity at the border so that declarations are consistent and shipments are not held up by classification disputes.

The key provisions

• Reference commodity numbers. The announcement publishes the customs commodity numbers for the newly listed varieties, for reference in customs declaration.
• Partial coverage. The announcement expressly states that the commodity numbers cover only *part* of the controlled goods. If the actual goods being imported or exported fall outside the listed commodity-number range, the declarant must still declare truthfully.
• Legal basis. The announcement is issued under the Drug Administration Law, the Customs Law and related laws and regulations.
• Effective date. 1 October 2026.

The honest-declaration clause is the operative discipline: the commodity numbers are a facilitation tool, not a safe harbour. A shipment containing a newly controlled substance but classified under a different HS number remains subject to the controlled-substance rules, and the declarant bears the duty to reflect the true nature of the goods.

Context: the wider psychotropic-substance framework

Medicinal psychotropic substances are regulated separately from narcotic drugs but within the same family of controlled-substance rules. Imports and exports generally require permits issued through the drug-administration system, and customs releases goods against those permits together with normal declaration documents. Companies trading in active pharmaceutical ingredients (APIs) or finished drugs that touch the controlled list must:

• verify whether each product contains a catalogue substance;
• confirm whether a China-approved formulation exception applies;
• obtain the appropriate permits before shipment; and
• declare accurately at customs using the published reference codes where applicable.

What companies should do before 1 October 2026

For pharmaceutical importers and exporters — including foreign companies shipping APIs into China for contract manufacturing, or exporting controlled finished products — the practical checklist is:

• Re-screen the product portfolio. Compare every SKU in the import/export pipeline against the expanded medicinal psychotropic catalogue, paying attention to the three new substances by both Chinese and international names.
• Map the formulation exception. The catalogue addition excludes drug preparations approved for marketing in China. Confirm whether the product you ship is such an approved preparation and keep supporting registration documents in the compliance file.
• Update declaration masters. Where a controlled substance is involved, update product masters, customs-classification records and the reference commodity numbers so that declarations after 1 October use the correct codes.
• Check permit status. Confirm that the necessary import/export permits are in place and that the responsible internal or third-party declarant understands the split of duties between NMPA permits and customs release.
• Prepare for audits. Regulators and customs may test whether declared goods match actual substance content. Retain certificates of analysis, formulation sheets and supply-chain records that demonstrate the true state of each shipment.
• Brief logistics and CRO partners. If a third party handles declaration or cross-border logistics, circulate the announcement so screening updates are applied across the chain, not only at the licence holder.

Practical notes for foreign pharmaceutical companies

Foreign companies most affected are those that supply or buy the three newly controlled substances — or that manufacture medicines where these substances appear as intermediates or impurities above applicable thresholds. Points worth noting:

• The announcement is a border-declaration facilitation measure; it does not by itself change the permit regime, which continues to apply to controlled substances.
• The “approved formulation” carve-out is narrow: it protects drug preparations approved for marketing in China, not raw substances or unapproved preparations.
• Given the 1 October effective date, any shipment booked for late September and arriving in October should be screened under the new scope to avoid a compliance gap.

Sources

• 国家药品监督管理局 — 国家药监局 海关总署关于药用类精神药品进出口申报事项的公告（2026年第84号）: https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20260902092356142.html
• 中华人民共和国海关总署 — 政务公告列表（含2026年第84号、第128号、第129号等）: http://www.customs.gov.cn/
• 医药魔方 — 药用类精神药品进出口申报事项公告（品种与施行日期摘要）: https://bydrug.pharmcube.com/news/detail/484ba2600ed6d80d29192ad8ba49dca8

Related reading

• see also: China’s 2026 customs clearance guide for the ninth CIIE (370-ciie-2026-customs-clearance-guide)
• see also: Guangdong’s international medical services pilot and pharma investment (329-guangdong-international-medical-services)

药用类精神药品进出口申报新规：国家药监局 海关总署2026年第84号公告解读

概述

2026年8月28日，国家药品监督管理局与海关总署联合发布《关于药用类精神药品进出口申报事项的公告》（2026年第84号），就近期增列入药用类精神药品目录的品种，公布供进出口通关申报参考的海关商品编号。公告自2026年10月1日起施行。

公告建立在更早一步的监管动作之上：国家药监局、公安部、国家卫生健康委联合发布调整药用类精神药品目录的公告，将甲氧依托咪酯、乐瑞托咪酯、索安非托增列入药用类精神药品目录（在中国境内批准上市的含上述物质的药品制剂除外）。随后，依据《药品管理法》《海关法》等法律法规，2026年第84号公告出台，为贸易企业提供具体的通关申报参考编号。

为何重要

中国在药物管制体系下对精神药品实行严格管控，此类物质的进出口需取得准许证并合规申报。本次公告的意义有二：

1. 管制范围刚刚扩大。 甲氧依托咪酯、乐瑞托咪酯、索安非托三个品种被增列入药用类精神药品目录。任何将上述物质运入或运出中国的企业（中国批准上市制剂除外），如今均落入管制物质制度范畴。
2. 海关有了公开的参考编码。 通过为新增品种提供海关商品编号，国家药监局与海关总署意在减少口岸的归类不确定性，使申报口径一致，避免货物因归类争议而被滞留。

主要条款

• 参考商品编号。 公告公布新增列品种的海关商品编号，供通关申报参考。
• 部分覆盖。 公告明确，公布的编号仅包含管制商品中的部分商品。实际进出口商品超出相关商品编号范围的，仍应当如实申报。
• 法律依据。 公告依据《药品管理法》《海关法》等法律法规制定。
• 施行日期。 2026年10月1日。

“如实申报”条款是操作性纪律：商品编号是便利工具，而非安全港。一批含有新管制物质但归入其他HS编码的货物，仍适用管制物质规则，申报人有义务如实反映货物的真实属性。

背景：更宽的精神药品监管框架

药用类精神药品与麻醉药品分列管制，但同属管制物质规则体系。其进出口一般需通过药监系统取得准许证，海关凭准许证及常规申报文件放行。经营涉及管制清单的原料药或制剂的贸易企业，必须：

• 核实每个产品是否含有目录内物质；
• 确认是否适用”中国批准上市制剂”例外；
• 在发货前取得相应准许证；
• 在口岸按公布的参考编码如实准确申报。

2026年10月1日前应做的事

对医药进出口企业——包括向中国境内合同生产方供应原料药、或出口受管制成品的外国公司——实用核查清单如下：

• 重新筛查产品组合。 将进出境管线中的每个品目与扩围后的药用类精神药品目录逐一比对，重点关注三个新增品种（中英文名称均需核对）。
• 核实制剂例外。 目录增列不包含在中国境内批准上市的药品制剂。请确认你所运产品是否属于此类获批制剂，并在合规档案中留存注册证明文件。
• 更新申报主数据。 若涉及管制物质，更新产品主数据、海关归类记录与参考商品编号，确保10月1日后的申报使用正确编码。
• 核查准许证状态。 确认必要的进出口准许证已就位，并让内部或第三方申报人清楚理解药监准许证与海关放行之间的职责分工。
• 备妥审计材料。 监管部门与海关可能核查申报货物与实际物质含量是否一致。留存检验报告、制剂配方单与供应链记录，以证明每批货物的真实状态。
• 同步物流与外包伙伴。 若由第三方代理申报或负责跨境物流，应转发公告，使筛查更新贯穿整个链条，而不只停留在持证人一端。

给外国药企的实务提示

受影响最大的外国公司，是那些供应或采购上述三种新管制物质的企业，或在其药品中将此类物质作为中间体、杂质（超过适用阈值）出现的企业。值得注意：

• 本公告属口岸申报便利化措施，本身并不改变准许证制度，管制物质仍须适用该制度。
• “批准制剂”例外范围较窄：它保护在中国获批上市的药品制剂，不涵盖原料物质或未获批制剂。
• 鉴于10月1日生效，凡9月下旬订舱、10月到港的货物，都应按新范围筛查，避免出现合规空档。

来源

• 国家药品监督管理局 — 国家药监局 海关总署关于药用类精神药品进出口申报事项的公告（2026年第84号）: https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20260902092356142.html
• 中华人民共和国海关总署 — 政务公告列表（含2026年第84号、第128号、第129号等）: http://www.customs.gov.cn/
• 医药魔方 — 药用类精神药品进出口申报事项公告（品种与施行日期摘要）: https://bydrug.pharmcube.com/news/detail/484ba2600ed6d80d29192ad8ba49dca8

相关阅读

• 见：第九届进博会海关通关须知（370-ciie-2026-customs-clearance-guide）
• 见：广东国际医疗服务试点与医药投资（329-guangdong-international-medical-services）