Core Expert Resource: Technical Expert of the European Pharmacopoeia Commission – Kou Guotong

Mr. Kou Guotong: Legal Representative, Executive Director and General Manager of the company. He is a Technical Expert of the European Directorate for the Quality of Medicines & HealthCare (EDQM) and a member of the drafting group for EP 12.0.

As the founder and Technical Director of Shijiazhuang Kairuide Pharmaceutical Technology Development Co., Ltd., he brings nearly twenty years of experience in drug research, clinical studies and regulatory submissions. He has been selected into the expert databases for U.S. FDA drug submissions and European drug submissions.

He has strategic collaboration experience with well-known domestic and international CROs, and has executed monitoring and auditing projects for international multi-center clinical trials, building compliance teams under GLP, GCP and GMP-like standards.

He has led the completion of dozens of projects including U.S. ANDA, 505(b)(2) new dosage form modifications, OTC drugs, ICH-compliant studies for APIs, and domestic generic drug consistency evaluations. He has organized the R&D and submission of more than thirty solid/liquid dosage form generic drugs and over twenty deficiency response studies, and has repeatedly participated as a technical expert in FDA Pre-Approval Inspections (PAI) and on-site inspections by the National Medical Products Administration (NMPA).

In 2024–2025, Mr. Kou Guotong serves as Chief Expert of the Pharmaceutical Excipients Branch of the China Chamber of Commerce for Import and Export of Medicines and Health Products. He has been continuously invited to deliver keynote speeches at national industry platforms such as the inauguration ceremony of the Pharmaceutical Excipients Branch of the Chamber of Commerce and the CPHI China Pharmaceutical Excipients Internationalization Salon. He is one of the few authoritative experts in China with full-lifecycle practical experience spanning “pharmacopoeia drafting – registration submission – on-site inspection” for innovative drugs.