Adverse drug reaction reporting process and reporting time limit

Adverse drug reaction reporting process and reporting time limit means that all medical institutions, production enterprises and other relevant units need to report adverse drug reactions to the drug regulatory authorities within the specified time. The declaration process includes preliminary identification, verification, evaluation and announcement, aiming at effectively ensuring the safety of people's medication.

Adverse drug reaction reporting process and reporting time limit is also an important aspect in the field of drug management, which is mainly reflected in the stages of adverse drug reaction information collection, reporting, processing, evaluation and feedback. Specifically, medical institutions and pharmaceutical production enterprises must complete online reports within 24 hours after discovering adverse drug reactions, and fill in relevant data and information on the platform for collecting adverse drug reaction information in accordance with the technical standards of the health administrative department of the State Council, and keep patient information confidential. According to the types of reporting content and the roles of participants, the reporting process can be roughly divided into drug information collection, information monitoring, targeted investigation, archiving and reporting management step by step. Through the corresponding evaluation and monitoring system, adverse drug reactions and problems are found in time, and corresponding measures are taken to solve them in time to ensure the safety of people's medication.

How should doctors prompt patients to report possible adverse drug reactions? Doctors should explain their doubts to patients and provide relevant help. It mainly includes informing patients about the actual drug use, drug information to be collected, data collection standards, work arrangements and precautions for not revealing personal privacy. At the same time, it can also provide the consultation telephone number and contact channel of the drug supervision department, so as to facilitate patients and their families to receive technical guidance in time.

Effectively promoting the reporting process and reporting time limit of adverse drug reactions is not only a necessary measure to protect national health rights and interests, but also reflects the scientific and standardized process of drug management industry. In the daily supervision work, all levels should continue to carry out information exchange and cooperation, constantly improve the process of each link and stage, optimize the means of information feedback, and better protect the people's drug safety and health.

Legal basis:

"Drug Administration Law of People's Republic of China (PRC)" Article 56 The drug supervision and administration departments at all levels shall establish an adverse drug reaction monitoring network to collect and analyze adverse drug reactions.