What is Pharmacovigilance/Medical Device Vigilance in Original Translation Sharing? Official note from the WHO

英文原文来源：WHO global benchmarking tool rev. VI ver. 1, Vigilance (VL): indicators and fact sheets. Page 5 of 43

The translation is as follows:

Medical product vigilance (including pharmacovigilance, medical device vigilance) is defined as science and activities related to the monitoring, evaluation, understanding and prevention of adverse reactions or any other medical product-related issues, and vigilance work is essential to ensure the safe and effective use of high-quality medical products in the country. Vigilance activities should be carried out in countries based on a risk management approach.

A reporting system should be established to monitor the safety of medical products. One of the important functions of the reporting system is to monitor and evaluate side effects of pharmaceuticals/medical devices and other product-related safety issues (e.g., adverse reactions to drugs (ADR) and adverse events of vaccination (AEFI)). While common side effects may be monitored during clinical trials (Phase I, II, and III) prior to product approval, rare events are more likely to be observed after a medical product is marketed. Other unexpected events can also be caused by errors and can therefore occur at any time during product development and sales. The severity, causes, and public health consequences of side effects can vary. It is therefore recommended that each State establish its own vigilance system. In general, a vigilance system should monitor all types of patient injuries that may be associated with medical products, whether due to inadequate product quality, improper use (e.g., medication errors), or adverse reactions inherent in the product.

Serious adverse effects, such as AEFI, often attract public attention and can reduce confidence in medical products and the regulatory and health systems as a whole. If not handled properly, these issues can have a significant negative impact on public health. Therefore, it is crucial to establish a post-market medical product vigilance system.

Networking and collaboration with other international agencies and regulatory agencies is a reasonable way to obtain, share and exchange information about the safety of medical products. This information, in turn, helps to make informed scientific decisions. In order to facilitate networking and exchange of information with other international agencies and regulatory bodies, countries are expected to harmonize vigilance systems and security reporting requirements in accordance with agreed international standards.