ESG Report 2021

Pharmacovigilance Quality Management Standard Training In order to regulate pharmacovigilance analyzed how to do a good risk control from activities throughout the life cycle of drugs, the perspective of pharmacovigilance with t h e N a t i o n a l M e d i c a l P r o d u c t s reference to actual work experience. The Administration of the PRC issued and training provided employees with solid required the implementation of the Good pharmacovigilance knowledge, and played Pharmacovigilance Practice (“GVP”). The an active role in promoting all employees to GVP clearly regulates that drug marketing participate in product quality assurance. authorization holders and drug registration The Group will continue to enhance the applicants shall establish and continuously awareness of pharmacovigilance of all improve the pharmacovigilance system as employees, actively implement the main required, and carry out pharmacovigilance r e s p o n s i b i l i t y o f d r u g m a r k e t i n g activities. a u t h o r i z a t i o n h o l d e r s , b u i l d a In order to effectively implement the pharmacovigilance team, formulate a sound preparation work related to the GVP, the pharmacovigilance system, establish a quality department of the Group invited pharmacovigilance quality system covering experts in the pharmacovigilance field to information collection, data analysis, signal provide employees with training on the management, risk control, adverse reaction establishment and operation of the GVP monitoring, identification, evaluation and system and related content of the GVP. Mr. reporting, and continuously improve the Liu Defu, the Group's Quality Director, and o p e r a t i o n e f f i c i e n c y o f t h e leaders and employee representatives from pharmacovigilance system to ensure that factories and different departments pharmacovigilance activities continue to attended the training. Experts meet the requirements of relevant laws and the knowledge of pharmacovigilance from regulations. various aspects such as the interpretation of pharmacovigilance system in the Drug Administration Law of the People's Republic of China ( 《中華人民共和國藥品管理法》 ), the Vaccine Administration Law of the People's Republic of China ( 《中華人民共和 國 疫 苗 管 理 法 》 ), the Measures for the Supervision and Administration of Drug Production ( 《藥品生產監督管理辦法》 ), the origin of pharmacovigilance concept, the introduction of the Good Pharmacovigilance Practice ( 《藥物警戒質量管理規範》 ), the exchange of views and thinking, and popularised Product Labelling and Description The Group has formulated and implemented relevant the Provisions on the Administration of management systems for label packaging materials Pharmaceutical Directions and Labels and are in accordance with laws and regulations. All package subject to examination, filing and approval by the inserts and labels comply with the requirements in National Medical Products Administration. 47 Environmental, Social and Governance Report 2021 The United Laboratories International Holdings Limited