Drug safety management-always on the road

Since the state officially began to implement the system of "direct reporting of adverse drug reactions by drug marketing license holders" in 2019, the construction of drug safety and alert system has become an important responsibility of safety management of pharmaceutical enterprises. In order to improve the ability and level of drug marketing license holders to monitor adverse drug reactions, the National Adverse Drug Reaction Monitoring Center and Jiangsu Adverse Drug Reaction Monitoring Center once again held the ''Drug Marketing Authorization "from July 17 to July 19, 2019. More than 600 representatives from national drug manufacturers, drug regulatory and medical institutions and other departments participated in the training.

Our leaders attach great importance to drug safety management and pharmacovigilance, and once again designate the company's pharmacovigilance department and full-time adverse drug reaction management office staff to participate in this special training.

In this study and training, experts from the National Adverse Drug Reaction Monitoring Center and Jiangsu Adverse Drug Reaction Monitoring Center respectively introduced the progress of adverse drug reaction monitoring in China and the analysis of key points in the establishment of the monitoring system for "drug marketing license holders", the interpretation of the revision points of the adverse drug reaction/event report form for marketing license holders (trial), the implementation ideas of the post-marketing case safety report E2B(R3) and the introduction of data elements, among them, MedDRA and other medical terms overview and application, MedDRA term selection and coding skills become the main points of learning, domestic pharmacovigilance experts also gave extensive and in-depth explanations and interpretations on the Guiding Principles for Clinical Safety Literature Evaluation of Listed Drugs (for Trial Implementation), literature resources and retrieval methods for drug safety evaluation, analysis and evaluation of multi-source safety data of listed drugs, and guidelines for writing annual reports on adverse reaction monitoring of listed drug holders.

Through this study, the full-time management personnel of our company's pharmacovigilance carried out targeted self-examination and combing of the collection, summary, analysis, and reporting of adverse reaction reports of key products to ensure that drug safety management work is more standardized and effective. This study provides legal and theoretical guarantee for the construction of the system system of "drug marketing license holder" such as timely discovery of drug risk signals, clinical rational application evaluation, early warning of safety risks, and ensuring the safety of patients' medication, and also plays a more active role in promoting the pharmacovigilance work of our company in the process of drug production, quality control, sales and application.