In February 2025, the inhalation preparation production base of CF PharmTech located in Suzhou successfully passed the Qualified Person (QP) audit of the European Union (EU) and obtained a compliance audit report issued by the QP. This marks that CF’s quality management system and production capacity have met t he EU Good Manufacturing Practice (GMP) standards, laying a solid foundation for the company to further expand its international market presence.

The EU QP audit was conducted in accordance with EudraLex Volume 4 (EU GMP Guidelines for Medicinal Products) and relevant guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). It covered a comprehensive review of CF’s production management system, quality control system, plant facilities and equipment, data integrity, and computerized systems. The auditors highly recognized the company’s high-standard quality management system, advanced facilities and equipment, as well as its professional technical team, and confirmed that the production base complies with EU GMP requirements.

Passing the EU QP audit is a crucial step in the company’s internationalization strategy. It not only serves as recognition of the company’s quality management system but also further strengthens its competitive advantages in the global inhalation preparation sector. In the future, CF will continue to adhere to the philosophy of "Quality First" and remain committed to providing high-standard and high-quality inhalation preparation products to global customers. Meanwhile, the company will further accelerate its global layout, promote more innovative drugs to enter the international market, and provide more high-quality treatment options for patients around the world.