As an important component of traditional Chinese medicine, Chinese medicines are increasingly attracted to the attention and favour of countries around the world. Despite growing market demand, the export process of Chinese medicines is full of challenges, especially with strict international quality standards and complex export regulations. This article aims to explore the key requirements and processes of Chinese medicines exports to help better understand and comply with relevant regulations and ensure that Chinese medicines reach the global market smoothly.

A. Supervisory authorities and their responsibilities

Chinas pharmaceutical exports are strictly regulated in China, and the main regulatory authorities include the General Administration of Customs and its subordinate inspection and sanitation departments. These agencies are responsible for ensuring that the pharmaceutical exports comply with domestic and foreign legal regulatory requirements, as well as specific standards of the importing country.

General Department of Customs:Responsible for formulating and implementing the export policy of Chinese pharmaceutical materials, and overseeing compliance in the export process.
2) Inspection of the health department:Specifically carry out the inspection and sanitation work of Chinese pharmaceutical materials to ensure that all exported Chinese pharmaceutical materials meet international quality and safety standards.

Regulatory Requirements for Exported Drug Materials

According to the Import and Export Medicines Inspection and Supervision Management Measures, exported medicines must meet a series of strict requirements, these requirements cover quality control, enterprise qualification and product standards and many other aspects.

Quality and safety standards:
All exported pharmaceutical materials should be listed in the Peoples Republic of China Pharmaceutical Code, ensuring their quality meets the national pharmaceutical standards.

Qualification requirements for export production enterprises:
Production enterprises must establish a complete quality management system, including detailed records of all aspects of raw material procurement, production processing, product inspection, etc. They must be equipped with full-time sanitation managers to ensure that every aspect of the production process complies with regulatory requirements.

Export Regulations Declaration:
Exportors or their agents must submit export declarations through Chinas single window of international trade, ensuring the authenticity and completeness of all information. Relevant contracts, invoices, packaging documents and other documents must be provided, as well as the factory certificate issued by the manufacturing enterprise.

Qualification Assessment and Attention

In order to ensure the smooth export of Chinese pharmaceutical materials, exporters must pass a series of qualification assessment procedures and pay attention to some special export notices.

Qualification assessment procedure:
Customs will conduct inspection and inspection of exported medicinal materials in accordance with the relevant laws and regulations; qualified Chinese medicinal materials will receive a certificate of inspection, allowing the exit; non-compliant products must be disposed of or refused to exit.
2 points of attention:
Exported medicinal materials should comply with the laws and regulations of the relevant country or region if they involve wild or endangered fauna and flora.

Exporting pharmaceuticals is a process involving multiple legal regulations and complex procedures. For exporters, understanding and strict compliance with these regulations is key to ensuring Chinese pharmaceuticals are exported smoothly. Through effective quality management and standardized export operations, potential legal risks can not only be avoided, but also the competitiveness of Chinese pharmaceuticals in the international market can be enhanced, further promoting the global spread of Chinese pharmaceutical culture.