Cross-Border Pharmaceutical Sales on E-commerce Platforms: The Legality Boundary and Core Risk Prevention Guide

Cross-Border Pharmaceutical Sales on E-commerce Platforms: The Legality Boundary and Core Risk Prevention Guide

With the restructuring of global pharmaceutical supply chains and the rise of digital trade, e-commerce platforms have become a significant channel for cross-border pharmaceutical sales. From 2021 to 2023, the global cross-border pharmaceutical e-commerce market grew at an average annual rate exceeding 40%, with the Chinese market, fueled by its vast consumer demand, ranking among the fastest-growing segments. However, as a special commodity, cross-border e-commerce sales of drugs constantly navigate between “policy dividends” and “compliance red lines.” On one hand, e-commerce provides consumers with more convenient access to overseas drugs, particularly meeting needs for medications not yet approved domestically and treatments for rare diseases. On the other hand, due to ambiguous regulatory policies, insufficient supply chain transparency, and challenges in quality control, disputes over legality and safety risks frequently arise. This article provides an in-depth analysis of the criteria for determining the legality of cross-border pharmaceutical sales via e-commerce platforms, outlines domestic and international regulatory frameworks, identifies core risk types, and proposes comprehensive compliance prevention strategies to support the industry’s规范 development.

I. Core Determination of Legality: The Compliance Boundary for Cross-Border E-commerce Pharmaceutical Sales

The legality of selling pharmaceuticals via cross-border e-commerce platforms fundamentally requires meeting the dual criteria of “regulatory authorization” and “risk control.” It revolves around four core dimensions: “Sales Entity Qualification, Product Access Scope, Transaction Model Compliance, and End-to-End Traceability.” The legality boundary varies significantly across different scenarios.

(1) Core Prerequisites for Legal Sales

• Entity Qualification Compliance:
  • The e-commerce platform must obtain relevant regulatory licenses. In China, platforms need an Internet Drug Information Service Certificate and Medical Device Online Sales Filing. Foreign platforms must appoint a domestic Authorized Representative (AR) in China to bear compliance responsibilities.
  • The药品 supplier must hold production and sales qualifications in the target market (e.g., FDA CGMP, EU GMP certification). Models using domestic保税 warehouses require a Drug Business License.
  • Case Example: Major platforms like JD Health and Alibaba Health have established themselves as benchmarks for legal cross-border pharmaceutical e-commerce by securing domestic pharmaceutical operation licenses and partnering with compliant pharmaceutical companies.
• Product Access Compliance:
  • Inclusion on the Cross-Border E-commerce Positive List: China currently only allows drugs listed on the Cross-border E-commerce Retail Import Commodity List to be sold via the “Bonded Online Import” model. This mainly covers low-risk categories like non-prescription drugs (OTC), such as antipyretics/analgesics, vitamin supplements, and dermatological medications.
  • Compliance with Target Market Standards: Drugs must hold marketing authorization in the exporting country (e.g., FDA registration, EMA authorization) or be WHO-prequalified. Quality standards must align with Chinese Pharmacopoeia, the importing country’s pharmacopoeia, and international standards.
  • Prohibited Categories: Prescription drugs (except under special approval), narcotics, psychotropic substances, radioactive drugs, and certain high-risk biologics are explicitly prohibited from cross-border e-commerce retail.
• Transaction Model Compliance:
  • Two Legal Models: “Bonded Online Import” (drugs pre-stored in domestic保税 warehouses, shipped upon order) and “Direct Purchase Import” (shipped from overseas upon order, cleared by customs). The “Bonded” model applies only to drugs on the Positive List. The “Direct Purchase” model, though popular, operates in a政策模糊 space and must satisfy requirements for personal use and reasonable quantity.
  • Illegal Models: “Daigou” (personal shopping代理), “group buying,” and other informal channels where unqualified individuals or entities sell overseas drugs via platforms are illegal.
• End-to-End Traceability Compliance:
  • Achieve “traceable source, trackable destination, accountable responsibility.” Drugs must carry unique traceability codes linking data across production, import, warehousing, logistics, and sales.
  • Provide data interface access to regulatory authorities for dynamic supervision and verification by Customs and the National Medical Products Administration (NMPA).

(2) Core Controversies Regarding Legality

• The Policy Ambiguity of the “Direct Purchase Import” Model:
  • Derived from Article 65 of China’s Drug Administration Law, which allows patients to legally obtain overseas drugs, this model is not explicitly incorporated into the cross-border e-commerce regulatory framework, creating a policy “gray area.”
  • Divergent Local Regulatory Attitudes: Some regions adopt a cautious approach, requiring platform filing and risk control plans. Others penalize activities as “illegal drug importation,” increasing industry compliance costs.
• The Lagging Expansion of the Positive List vs. Market Demand:
  • The current Positive List covers few categories, primarily low-risk OTC drugs, insufficient to meet consumer demand for unapproved drugs and rare disease treatments.
  • The industry widely advocates for dynamic list expansion to include more safe, widely needed OTC drugs and some urgently required处方 drugs under safety guarantees.

II. Domestic and International Regulatory Frameworks: The “Rule Red Lines”

Regulation involves multiple agencies (Customs, NMPA, National Health Commission). Domestic and international policies各有侧重 but are based on “Safety & Control, Facilitation of Circulation.”

(1) Core Requirements of China’s Regulatory Policy

• Core Laws & Regulations:
  • Drug Administration Law: Sets the legality baseline, mandating approval for drug imports and prohibiting imports without批准证明.
  • Cross-border E-commerce Retail Import Commodity List: Implements Positive List management for eligible drug categories.
  • Measures for the Administration of Internet Drug Information Service & Measures for the Supervision and Administration of Online Sales of Medical Devices: Regulate drug information发布 and online sales, obligating platforms to conduct qualification reviews, product checks, and risk warnings.
• Regulatory Agency Responsibilities:
  • Customs: Handles import clearance, verifying Positive List compliance, declaration authenticity, and quantity reasonableness. Levies duties and import VAT.
  • NMPA: Oversees drug quality, investigates counterfeit/substandard drugs, verifies platform/supplier qualifications, conducts unannounced inspections.
  • State Administration for Market Regulation (SAMR): Oversees market conduct, investigating false advertising, price fraud, and IP infringement.
• Recent Policy Developments:
  • The NMPA has stated it will cooperate in improving the Positive List,研究 feasible pathways for cross-border e-commerce drug imports, and strengthen事中事后 supervision.
  • Pilot Programs: Beijing and Henan have approved pilot programs for cross-border e-commerce retail drug imports via the保税 model, accumulating experience for nationwide推广.

(2) Core Requirements of International Regulatory Policies

• United States (FDA) Requirements:
  • Entity Qualification: Foreign platforms must register with the FDA, appoint a U.S. agent responsible for product quality.
  • Product Access: Drugs require FDA registration/approval. OTC drugs must comply with FDA labeling/insert requirements, displaying NDC codes.
  • Regulatory Focus: Aggressively targets cross-border sales of counterfeit/substandard drugs. Non-compliant platforms face Import Alerts, fines, and criminal prosecution.
• European Union (EMA) Requirements:
  • Entity Qualification: Foreign platforms must appoint an EU-based Authorized Representative (AR) with pharmaceutical business qualifications for regulatory communication.
  • Product Access: Drugs require EMA centralized or member-state authorization. APIs need CEP certificates. Labels/inserts must be in the importing member state’s language.
  • Regulatory Focus: Mandates platform traceability systems integrated with the EU Falsified Medicines Directive (FMD) platform for end-to-end traceability.
• WHO Requirements:
  • Develops guiding principles for cross-border pharmaceutical e-commerce, emphasizing “Safety, Efficacy, Quality.” Sold drugs should meet International Pharmacopoeia standards.
  • Promotes global regulatory harmonization and encourages developing countries to建立 traceability systems to prevent counterfeit drug influx.

III. Core Risk Types in Cross-Border E-commerce Pharmaceutical Sales and Case Analysis

Despite rapid growth, significant risks spanning legal compliance, quality safety, supply chain, and IP pose key bottlenecks.

(1) Legal Compliance Risk: The Most Direct “Red Line Risk”

• Common Issues: Lack of required licenses (platform/supplier); Selling beyond permitted scope (off-list drugs,处方 drugs, high-risk biologics); False customs declaration (misdeclared name, specs, quantity, composition).
• Case (2024): A platform was fined 5 million RMB by the NMPA for selling overseas处方 drugs not on the Positive List; products were confiscated. Another foreign platform had its drugs seized by Customs for lacking a domestic AR, leading to its placement on an “Import Dishonesty List” and suspended跨境 sales资格.

(2) Quality & Safety Risk: The Core “Public Health Risk”

• Common Issues: Counterfeit/substandard drugs (fake originators, expired drugs, off-spec content); Improper transport/storage (冷链 temperature excursions, inadequate shock/contamination protection reducing efficacy); Non-compliant labeling/inserts (incomplete info, lack of Chinese) leading to misuse.
• Case (2023): Imported antipyretics sold on a platform were found to have only 30% of the declared active content (substandard), rendering them ineffective for multiple consumers. The platform was ordered to rectify and compensate. In another case, a冷链 vaccine shipment became无效 due to a transport excursion (12°C), was destroyed by Customs, with the platform bearing the loss.

(3) Supply Chain Risk: The Most Concealed “Chain Risk”

• Common Issues: Low supply chain transparency (lax supplier vetting,无法 verifying drug origin); Poor保税 warehouse management (non-compliant storage conditions,混乱 inventory with expired drugs); Logistics risks (long transit times exceeding expiry, damaged/contaminated packaging).
• Case: A保税 warehouse’s temperature monitoring failed, storing冷藏 drugs (2-8°C) at 15°C for 24 hours, destroying the batch (loss >3 million RMB). Another platform’s supplier provided falsified credentials, supplying假药 from a domestic作坊. The platform, failing its审核 duty, was fined 10 million RMB by the NMPA.

(4) Intellectual Property Risk: The Most Overlooked “Infringement Risk”

• Common Issues: Trademark infringement (selling drugs with counterfeit originator trademarks); Patent infringement (selling generics infringing originator patents, especially during保护期); Copyright infringement (unauthorized copying of inserts/promotional materials).
• Case: A platform selling overseas generics was sued by an originator for trademark infringement, resulting in 8 million RMB damages and product delisting. Another platform selling unauthorized (non-MPP) generic COVID-19 oral drugs had shipments seized by Customs for patent infringement, landing the platform on an “IP Infringement Blacklist.”

(5) Consumer Rights Protection Risk: The Most Sensitive “Public Concern Risk”

• Common Issues: False advertising (exaggerated claims like “cure,” “miracle”); Difficult returns/refunds (denied due to drug特殊性, hindering维权 for defective products); Lack of post-sale咨询 (no professional pharmacist guidance on usage,禁忌, adverse reactions).
• Case: A merchant claimed its overseas保健品 could “cure diabetes,” misleading consumers. SAMR imposed a 2 million RMB fine. A consumer who experienced an allergic reaction to an imported dermatological drug purchased online was denied a return/refund by the platform, highlighting the high维权 cost for跨境 transactions.

IV. Comprehensive Compliance Prevention Strategies: A Practical Guide for Platforms and Pharmaceutical Companies

To address core risks, platforms and companies must build an end-to-end “Pre-Event Review, In-Process Monitoring, Post-Event Response” compliance system, precisely aligning with regulatory demands to balance risk control and business growth.

(1) Pre-Event Review: Fortifying the “First Line of Defense”

• Entity Qualification Review:
  • Platform: Obtain required licenses (Internet Drug Info Service Cert, etc.). Foreign platforms must appoint a domestic AR with clear mandate.
  • Supplier Review: Establish a supplier准入 mechanism, verifying production licenses (GMP), marketing authorizations (FDA/EMA), and cross-border sales授权 documents. Prioritize internationally certified正规药企.
  • Ban Personal Sellers: Prohibit individuals from selling跨境 drugs; only permit licensed enterprises.
• Product Access Review:
  • Whitelist System: Only allow Positive List drugs via the保税 model. Strictly vet “Direct Purchase” drugs against prohibited categories.
  • Product Quality Review: Require suppliers to provide per-batch CoA, Certificate of Origin, import declaration. Ensure quality standards are met.
  • Labeling/Insert Review: Labels must show Chinese name, strength, batch, expiry, manufacturer, domestic AR contact. Inserts require Chinese translation for clear consumer understanding.
• Supply Chain Review:
  • Select Compliant Logistics: Prioritize GDP-certified logistics providers with跨境医药 transport资格. For冷链, choose validated cold chain providers.
  • 保税 Warehouse Management Review: Ensure warehouses meet drug storage standards (temperature/humidity monitoring, ventilation, fire safety). Establish inventory management with regular stock-taking and expired drug disposal.

(2) In-Process Monitoring: Dynamic Risk Prevention

• Transaction Behavior Monitoring:
  • Personal Purchase Limits: Enforce “personal use, reasonable quantity” by setting per-user, per-order limits (e.g., OTC drugs not exceeding a 3-month supply) to prevent “group buying”/”daigou.”
  • Anomaly Detection: Use big data to flag suspicious orders (same user多次 purchases, large quantities, delivery to medical institutions) for verification/interception.
• Quality & Traceability Monitoring:
  • End-to-End Temperature Monitoring: For冷链, use dual-path data loggers with real-time uploads and alarms for excursions.
  • Traceability System: Build a platform linking full-process data (production to sale). Provide regulatory data接口.
  • Regular Sampling: Partner with third-party labs for periodic testing (content, impurities, microbial limits). Delist non-compliant products immediately.
• Advertising & Post-Sale Monitoring:
  • Prohibit False Advertising: Review promotional content, banning absolute claims (“cure,” “miracle,” “no side effects”). Claims must be基于 inserts/clinical data.
  • Provide Professional咨询: Employ licensed pharmacists for consumer guidance on usage,禁忌, adverse reactions.
  • Establish Returns/Refunds Mechanism: Define clear conditions and processes. Offer unconditional returns/refunds for defective/damaged products, covering associated costs.

(3) Post-Event Response: Rapid Action and Risk Closure

• Violation Handling:
  • For资质不全 or超范围 sales, immediately delist products and suspend/close merchant accounts. Report serious cases to regulators.
  • Upon consumer complaint/quality issue, launch immediate investigation, suspend sales, and implement refunds/compensation after verification.
• Emergency Response Plans:
  • Quality/Safety Emergency: Initiate recall for non-compliant drugs, notify consumers, retrieve/destroy products, and submit recall reports to regulators.
  • IP Infringement Emergency: Delist upon complaint, investigate, and cooperate with rights holders if infringement is confirmed.
  • Regulatory Inspection Emergency: Prepare proofs of qualifications, product docs, traceability data for unannounced inspections by Customs/NMPA.
• Risk Review & Optimization:
  • Conduct regular post-incident reviews of violations, quality issues, and complaints to identify compliance gaps and optimize processes.
  • Track policy changes (Positive List updates, new rules) and adapt business models/compliance strategies promptly.

(4) Long-Term Development Strategy: Embracing Regulation and Industry Collaboration

• Active Policy Engagement:
  • Platforms/companies, via industry associations, should provide feedback to regulators, advocating for dynamic Positive List expansion and clearer “Direct Purchase” rules to foster a transparent policy environment.
  • Participate in developing industry standards (e.g., for跨境 traceability, supply chain management) to elevate overall compliance.
• Technology-Enabled Compliance:
  • Use Blockchain for immutable跨境 drug traceability, enhancing supply chain transparency.
  • Apply AI to optimize reviews (e.g., detecting false ads, anomalous transactions) for efficiency.
  • Build a跨境 pharmaceutical e-commerce collaboration platform integrating suppliers, logistics, regulators, and consumers for information sharing and协同监管.
• Consumer Education & Guidance:
  • Conduct科普 on合法 purchase channels, risks, and维权途径.
  • Establish consumer feedback mechanisms to promptly address concerns and build trust.

Conclusion

Cross-border pharmaceutical sales via e-commerce platforms are an inevitable outcome of the convergence of digital trade and the pharmaceutical industry. They meet consumer demand for diversified medications while opening new global channels for drug companies. However, the特殊性 of drugs dictates that跨境 sales must be “compliance-first.” Any practice that bypasses regulation or neglects quality and safety will be淘汰 by the market.

Currently, the industry is in a phase where “policy refinement” and “high-risk incidence” coexist. Legal compliance, quality safety, and supply chain management remain key constraints. Platforms and companies must abandon the “wild growth” mindset, constructing end-to-end compliance prevention systems and precisely adapting to regulatory requirements. Regulators need to accelerate policy完善, clarify the legality boundary of the “Direct Purchase” model, and dynamically expand the Positive List to enhance drug accessibility while ensuring safety.

As policy frameworks clarify, technology empowers, and industry standards mature, cross-border pharmaceutical e-commerce will enter a new stage of规范化 development. In the future, only those platforms and companies that adhere to compliance底线, prioritize quality and safety, and focus on consumer needs will secure their place in the global cross-border pharmaceutical e-commerce market, providing consumers with safer, more convenient, and higher-quality跨境 pharmaceutical services.