不良事件/反应报告

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不良事件/反应报告

Leaders from Pudong New Area Health Commission and Health Supervision Institute Conduct Official Inspection at Shanghai Zerun Biotech

2023.11.01

On October 19, 2023, Yu Donghai, Deputy Director of the Pudong New Area Health Commission, led an official delegation from the Health Commission and Health Supervision Institute to Shanghai Zerun Biotechnology Co., Ltd. (hereinafter referred to as “Shanghai Zerun”) for a roundtable discussion on occupational health and biosafety management in biopharmaceutical R&D enterprises. Deputy Director Miao Jiakui of the Health Supervision Institute and other officials attended the discussion, along with Dr. Zhou Chenliang, Executive Vice President of Shanghai Zerun, and other company representatives.

 

 

Dr. Zhou Chenliang extended a warm welcome to the visiting leaders and expressed gratitude for the guidance and recognition from regulatory authorities. He provided an overview of the company’s current development, occupational health management, and biosafety measures in its secondary pathogenic microorganism laboratory. Dr. Zhou also introduced Shanghai Zerun’s bivalent HPV vaccine, which has been included in several "public welfare initiatives" across China, such as HPV vaccination pilot programs for school-aged girls. As more provinces and cities launch cervical cancer elimination vaccination campaigns, he expressed confidence that Shanghai Zerun’s bivalent HPV vaccine would contribute to the health of more age-eligible girls.

 

Deputy Director Yu Donghai acknowledged Shanghai Zerun’s achievements in occupational health and biosafety in recent years. He noted that, as a long-standing R&D enterprise in Zhangjiang, Pudong, Shanghai Zerun has demonstrated strong innovation capabilities and delivered significant scientific outcomes. He encouraged the company to further enhance its management by strengthening accountability, standardizing practices, and improving training and evaluation systems. Additionally, Deputy Director Yu expressed high hopes for Shanghai Zerun’s HPV vaccine, encouraging the company to actively support the WHO’s "Global Strategy to Accelerate the Elimination of Cervical Cancer" and contribute to China’s efforts in this regard. He emphasized that regulatory authorities should support enterprises in developing and launching such products, while the Health Supervision Institute should foster a favorable business environment through compliance-based and rigorous enforcement, solicit feedback from enterprises, and elevate health supervision standards in the biopharmaceutical industry to promote its healthy growth.

 

Deputy Director Miao Jiakui also encouraged the company to provide more suggestions. He stressed that enterprises must not only fulfill their primary responsibilities in occupational disease prevention and biosafety but also strengthen employee care and implement self-inspection and correction mechanisms.

 

Following the discission, the leaders from the Health Commission and Health Supervision Institute toured Shanghai Zerun’s laboratories to gain further insights into its R&D team and scientific advancements.

 

 

 

The visit concluded with a group photo of all participants.