It is critical for Drug Marketing Authorization Holders (MAH) outside China to ensure that your Local Agent in China is fully compliant with the National Medical Products Administration (NMPA) standards.

A China Local Agent or distributor is responsible for establishing a comprehensive pharmacovigilance system, including the creation of SOPs for deviations and corrective actions (CAPA). They must provide the necessary documentation to the MAH to assist in creating the Pharmacovigilance System Master File (PSMF) and appoint both primary and secondary personnel for domestic pharmacovigilance. They must also configure a secure database, monitor and process all local safety data, conduct regular screenings of digital media, and identify relevant local scientific and medical reviews. The China agent is also tasked with evaluating and timely submitting Individual Case Safety Reports, developing and submitting regular safety reports, and planning for the submission of Risk Management Plans (RMPs). They must notify the MAH of any responses from regulatory authorities, ensure staff training, regularly test the continuity of pharmacovigilance activities, provide updates on regulations, and establish a system for handling Medical Information Queries (MIQs) with designated personnel.

To ensure that China agents are fully compliant, a PV audit would typically check these responsibilities as part of its evaluation process. The audit aims to ensure that all pharmacovigilance activities are compliant with regulatory requirements and are being executed effectively.

Cisema conducts thorough PV audits to ensure your China local agent complies with Chinese and Global GxP. Find out how we can help solve your China PV challenges below.