Abstract: Objective To explore modes and management methods of pharmacovigilance subcontracted by marketing authorization holders in China based on system requirements for marketing authorization holders stipulated by the Drug Administration Law and the Measures for the Supervision over and Administration of Pharmaceutical Production. Methods The laws and regulations enacted by drug regulatory authorities concerning pharmacovigilance subcontracted by marketing authorization holders in the United States, Europe, and the United Kingdom were studied and compared with those of China. Combined with the guidelines for pharmacovigilance entrustment agreements in China, opinions or suggestions on the development of pharmacovigilance commission activities were presented. Results & Conclusion To clarify the responsibilities and obligations of the holder and the trustee is the basis of pharmacovigilance commission. Holders should evaluate pharmacovigilance practices of trustees. Pharmacovigilance inspection by drug regulatory agencies should cover the inspection of trustees and focus on the inspection of compliance and management of drug safety data.

Key words: pharmacovigilance, commission, administration, marketing authorization holder