ESG Report 2025

73 8.6.1 Pharmacovigilance Management System All drug marketing authorisation holder companies under The United Laboratories have established independent pharmacovigilance departments, with team members possessing professional backgrounds in medicine, pharmacy or related fields, ensuring the professionalism and reliability of pharmacovigilance work. The core responsibilities of the pharmacovigilance department include: Systematically collecting, processing and reporting suspected adverse drug reaction information; Conducting signal detection and risk assessment, promptly identifying and controlling potential drug risks; Organising and implementing post-marketing safety studies of drugs, continuously tracking the long-term safety profiles of drugs; Coordinating pharmacovigilance-related education and training, preparing and updating management documents, and continuously improving the overall management standard. In addition, the Group has established a Drug Safety Committee, composed of representatives from multiple relevant departments, which is responsible for the assessment and decision-making of major drug risks, emergency response to major or urgent drug safety incidents, approval of risk control measures, and deliberation of significant pharmacovigilance-related matters. All departments maintain efficient collaboration and information exchange, forming a closed loop for the monitoring, identification, assessment and control of adverse drug reactions and other harmful reactions related to drug use. 8.6.2 Adverse Reaction Monitoring and Risk Control The United Laboratories has established a multi-channel, multi-dimensional information collection network for adverse drug reactions, ensuring full-process coverage of relevant parties including doctors, pharmacists and patients: Sales personnel interact with medical institutions and drug distributors in their daily work to collect clinical feedback in a timely manner; The drug leaflets clearly display contact telephone numbers and fax numbers to facilitate direct feedback from medical professionals and patients; A suspected adverse reaction feedback email address has been set up on the official website, with designated personnel responsible for receiving and processing submissions; Dedicated personnel are assigned to answer adverse reaction feedback telephone calls, ensuring that information channels remain open; Domestic and international academic literature and relevant websites are regularly searched to proactively capture safety information from clinical applications and academic research. In terms of risk identification and control, the Group conducts a systematic safety analysis of adverse reaction monitoring for each product category annually, and prepares an analysis report accordingly. At the same time, in accordance with the internally developed schedule for the submission of periodic safety reports and the annual plan, the Group completes the preparation and submission of reports within the prescribed time limits, ensuring continuous compliance with regulatory requirements. For collected adverse drug reaction events, the Group strictly follows the procedures for recording, analysing and handling. Depending on the severity of the event, reports are submitted to the national adverse drug reaction monitoring agency, the drug regulatory authority or the health administrative authority within the time limits prescribed by laws and regulations. In the event of a serious adverse drug reaction or a cluster adverse event, the Group will immediately initiate the drug recall procedure, issue a public announcement in a timely manner, and submit a summary report of the drug recall, ensuring that public health risks are minimised. 1 2 3 4 1 2 3 4 5 The United Laboratories International Holdings Limited 2025 Environmental, Social and Governance Report