What are the core responsibilities of a pharmaceutical export general agent?

Pharmaceutical Export General Agent (Exclusive Export Agent) asThe first person legally responsible., shall undertake the following core obligations:

• Product Registration and Filing: Responsible for the preparation and submission of drug registration documents for target markets.
• Quality System Maintenance: Ensuring compliance with the GMP certification requirements of importing countries (such as registration in the EU EudraGMDP database).
• Logistics Full Traceability: Establish a Cold Chain Transportation Monitoring System Compliant with WHO Standards
• Adverse Reaction Monitoring: Implementation of Pharmacovigilance System Management

What are the legal differences between a regular distributor and a general agent?

According to the regulations that will take effect in 2025,"Convention on the Allocation of Liability in International Pharmaceutical Trade"The legal differences between the two are primarily reflected in:

• Responsible entity:
  • The general agent directly assumes product liability.
  • The distributor is only liable for breach of contract.
• Regulatory Obligations:
  • The general agent shall establish a quality traceability system.
  • Distributors only need to verify the legality of the product.

What new regulatory challenges will the pharmaceutical export industry face in 2025?

Global pharmaceutical regulation exhibits three major trends:

• Electronic traceability becomes mandatory: 94 countries require UDI.Medical EquipmentUnique identifier
• Stricter Data Compliance: EU MDR New Regulations Require 10-Year Clinical Data Retention
• Environmental Standards Upgrade: WHO Introduces New Indicator for Recyclability Rate of Pharmaceutical Packaging (Effective July 2025)

Typical case: A Chinese API manufacturer was fined 200% of the cargo value by its Brazilian general agent for failing to complete GLP certification by ANVISA.

How to evaluate the compliance capability of potential partners?

It is recommended to establish an evaluation matrix from three dimensions:

• Qualification verification:
  • Check the filing status with regulatory agencies such as the FDA/EMA.
  • Verify ISO 13485 Medical Device Quality Management Certification
• Risk prevention:
  • Please provide the audit reports for the last three years.
  • Verify the GDP certification qualifications of logistics partners.

What key clauses must be included in a pharmaceutical general agency contract?

According to the 2023 ruling of the Court of Justice of the European Union (Case C-621/22), it is recommended to focus on:

• Liability Allocation Clause: Clearly define the responsibility attribution mechanism for product defects.
• Data Sovereignty Clause: Specifies the ownership and usage rights of clinical trial data.
• Emergency Handling Clause: Establish specific procedures for product recalls and a cost-sharing mechanism.

Special Notice: Legislation in multiple countries in 2025 mandates that contracts must includeArtificial Intelligence Review Terms, used for monitoring supply chain anomalies.