In 1974, Pharmacovigilance, PV was born in France. The former “Thalidomide Tragedy” has epoch-making significance for the international pharmacovigilance work. All countries have started to set up laws and regulations to supervise and continuously undergo improvement.
In 1999, with the release of the Measures for the Administration of Adverse Drug Reaction Monitoring (Trial Implementation) by the Chinese government, China’s PV formally entered the stage. As of Decree 81 of 2011, the Chinese government must expressly stipulate that enterprises must carry out new drug monitoring and monitoring of first import of drugs within 5 years, which necessitated the PV and also indicated the complete operation, normative and practical requirements of PV work.
However, at present, compared with more than one million reports received by the CFDA each year, the number of safety reports from pharmaceutical companies is quite small. The reason is the incomplete PV system in companies, a relatively low level of coordination among relevant departments and a lack of effective data collection methods.
In view of the status quo of such industries, we have in-depth interpretation of China's PV policies and regulations. With reference to the recognized PV process, technical guidelines and relevant policies and regulations, we have taken the lead in developing "eSafety PV system" in compliance with regulatory standards. Such electronic information management and standardization of operational processes solve practical problems and also has some predictability, so that companies can calmly deal with all types of surveillance.
The collection of adverse events and safety information data is crucial to the PV workflow, which requires close cooperation of grassroots personnel as well as system interconnection and integration after data upload.
Based on the gradual upgrade of eSafety system, we have rapidly developed “PV system mobile” to solve this fundamental problem. Today, eSafety Mobile 2.0 comes online.
The “mobile PV system”, mainly designed for front-line personnel (marketing, sales, medical affairs), aims at reducing the workload and improving convenience by quickly recording safety-relevant information on the mobile device site. In addition to its voice entry function, which has greatly reduced the time spent on manual input. Its other critical functions, such as embedded new reports, report alerts, query reports, supplementary questions and other key features, are easy to learn and operate, greatly reducing the workload and effectively improve the cooperation of pharmaceutical sales staff.
Mobile data information can be uploaded directly to eSafety PV system so that the PV personnel can gain access to first-hand information.