News
Standardized Development of MAH Pharmacovigilance System | The 19th Taizhou Pharmaceutical Regulatory Salon Event Successfully Held at Wanbangde
Date:
07 Nov,2023
To further enhance the overall quality management standards in pharmaceutical production in Taizhou City, the 19th Taizhou Pharmaceutical Regulatory Salon, themed "Standardized Construction of MAH Drug Vigilance Systems," was held on the morning of November 2 at Wanbangde. The event focused on addressing current challenges and uncertainties that companies are facing in building their vigilance systems. Attendees included Zhang Haijun, Director of the Drug Production Division at the Provincial Drug Administration; Ye Xingfu, a Level-3 Researcher at the Taizhou Municipal Market Supervision Bureau; Chen Bin, Director of the Drug Production Division; Tong Qingbo, Secretary and Director of the Wenling Municipal Market Supervision Bureau; Hong Liang, Vice President of the Taizhou Institute of Food and Drug Control; Zhu Keqiang, Member of the Party Committee and Deputy Director of the Wenling Bureau; as well as over 60 participants, including drug production regulators from various county (city, district) bureaus, heads of ADR monitoring centers, MAH representatives responsible for drug vigilance from Taizhou-based companies, and key personnel from medical institutions overseeing ADR oversight.
Director of the Drug Production Division, Provincial Drug Administration Bureau
Zhang Haijun delivers an important speech
Director Zhang pointed out that the country places great emphasis on implementing the pharmacovigilance system. Pharmacovigilance is not only a professional task but also everyone’s responsibility, and he outlined five key requirements:
● First, enhance ideological awareness and continuously strengthen the primary responsibility for pharmacovigilance.
● Second, proactively take responsibility and fulfill duties diligently, contributing to the company's high-quality development.
● Make sure to effectively implement measures, uphold the unity of knowledge and action, and comprehensively enhance the standards of pharmacovigilance work.
● We must strengthen comprehensive oversight across the entire lifecycle of pharmaceuticals—covering research and development, market approval, usage, and eventual withdrawal from the market.
● We must strengthen cross-regional cooperation and exchanges to jointly address the challenges and issues facing pharmaceutical safety.
Party Secretary and Director of Wenling Municipal Bureau
Tong Qingbo delivers a speech
Director Tong presented an overview of Wenling City's pharmacovigilance efforts, expressing his concern and support for advancing the standardization of pharmacovigilance practices. He also extended heartfelt gratitude and a warm welcome to leaders, experts, and scholars from various drug regulatory agencies, pharmaceutical manufacturers, and academic institutions.
ADR Inspection Report
Li Weihong, Deputy Head of the Adverse Drug Reaction Monitoring Division at the Taizhou Institute for Food and Drug Control, briefed and analyzed the status of drug adverse reaction monitoring and pharmacovigilance inspections over the past three years, and offered the following recommendations:
● Pharmacovigilance officers and dedicated staff in the pharmacovigilance department need to further familiarize themselves with the regulations and thoroughly study the specific provisions outlined in the rules.
● The legal representative or chief executive of MAH prioritizes PV activities, allocates sufficient resources, establishes a robust system, and ensures the effective implementation of pharmacovigilance efforts.
● Regulatory authorities need to further clarify the ambiguous provisions and provide technical guidance to sponsors on conducting PV activities.
Experience Sharing
▲ Zhang Shuxian from Huahai Pharmaceutical shared insights on the establishment and operation of a drug vigilance sentinel enterprise system, focusing on Huahai's pharmacovigilance practices, as well as the development and implementation of its pharmacovigilance system framework.
▲ Zhao Guanjia from Wanbangde Pharmaceutical Group shared his experience in ADR signal analysis and evaluation, covering four key aspects: the definition of signals, signal detection methods, signal analysis and assessment techniques, and illustrative examples aided by computer systems.
Seminar and Exchange
At the conclusion of the event, participants engaged in a panel discussion and exchange regarding the "Guidelines for the Establishment and Operation of the MAH Pharmacovigilance System (Draft for Comment)" and the "Pilot Manual for Individual Case Drug Adverse Reaction Evaluation and Signal Detection," both drafted jointly by the Wenling City Market Supervision Bureau, the Wenling City ADR Monitoring Center, and the Taizhou City Market Supervision Bureau.
Pharmacovigilance refers to the monitoring, identification, assessment, and control of adverse drug reactions and other harmful events related to medication use—covering every aspect of such reactions. Pharmacovigilance plays a critical role in pharmaceutical risk management. Actively promoting pharmacovigilance is a powerful tool in pharmaceutical regulation, helping to ensure proper and safe medication practices, strengthening the robust defense of patient safety, minimizing healthcare risks, and driving continuous improvements in drug quality.
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