How to choose a reliable pharmaceutical export general agent?

Key considerations when selecting a pharmaceutical export general agentThree major certifications:

• Pharmaceutical business license (must include import/export qualifications)
• ISO13485Medical DevicesQuality Management System Certification
• GSP/GMP compliance records for target markets (such as EU GDP certificate)

It is recommended to require the agent to provide records from the past 3 yearsExport cases of similar products, especially customs clearance records for target markets such as Europe, America, and ASEAN. The latest requirements for 2025 require confirmation of whether the agent has completedICH Q12 guidelinesCompliance upgrade.

What qualification documents are needed for general agent cooperation?

Basic document package must include:

• ManufacturersPharmaceutical production licenseandGMP certificate
• Product registration documents (including Chinese and English versions)
• CompleteCOA quality analysis report
• Newly added from 2025:Drug traceability coding systemFiling Certificate

Special attention: According toWTO-TBT AgreementLatest revision: Additional documentation required for medicines exported to the EUSCHEER risk assessment report.

What are the special requirements for pharmaceutical export logistics?

Pharmaceutical product transportation must meet:

• Complete temperature control records (cold chain products must comply withWHO-TRSPP standards) is
• Special dangerous goods packaging certificate (applicable to special categories such as biological preparations)
• Compliance withGDP transportation standardsDelivery acceptance process

Key market regulatory changes for 2025: US FDA begins implementation ofDSCSA regulationsFull-process traceability. It is recommended to choose providers withBlockchain logistics systemAgent service providers

How to avoid international payment risks?

Recommended adoptionPhased paymentMethod:

• 30% advance payment (based on proforma invoice)
• 40% payment against copy of bill of lading
• 30% payment after goods acceptance inspection

Priority use ofLC letter of creditSettlement. For 2025, it is recommended to choose options supportingDigital trade financingBanking channels. Special attention should be paid toOFAC sanctions listReal-time verification to avoid transactions involving sensitive countries

What to look for in emerging markets?

For emerging markets such as Africa and Southeast Asia:

• Apply in advanceWHO prequalification
• Prepare localized labels (including ingredient descriptions in local languages)
• Confirm target countryFiling with drug regulatory authoritiesRequested

Key notice for 2025: According toRCEP agreementUpgrade clause: ASEAN countries have generally reduced import tariffs by 3-8 percentage points. Priority is recommended for those already established in the regionBonded warehousing networkAgent service providers