Literature Screening
Literature Screening Definition Literature report is any adverse drug reactions reported in Published abstracts or Articles in medical/scientific journals Unpublished manuscripts involving case reports Important safety findings or clinical studies including posters, letters to the editors, and associated communication from scientific meetings. Regulatory Guidance of EMA and FDA According to the European Medicines Agency (EMA), […]
Management System
Management System Pharmacovigilance System Master File (PSMF) PSMF is a comprehensive document that describes the pharmacovigilance system of a company or organization involved in the development, manufacturing, and distribution of medicinal products. The purpose of the PSMF is to provide regulatory authorities with an overview of the company’s pharmacovigilance system and to demonstrate compliance with […]
Comparison Between China PV and Europe PV
Comparison Between China PV and Europe PV Comparison of China GVP and EMA GVP The European Medicines Agency (EMA) has developed 12 modules (I to XVI) for pharmacovigilance processes. The EMA has already covered the topics for Modules XI to XIV in other guidance documents, and thus they are null. The remaining modules play a […]
MAH Responsibility
MAH Responsibility MAH responsibilities elucidated in China GVP China GVP predominantly emphasizes the responsibilities of the Marketing Authorization Holder (MAH), as a substantial portion of its articles are dedicated to the comprehensive obligations. Reference: 1. China Good Pharmacovigilance Practice Announcement of the NMPA on the Publication of China Good Pharmacovigilance Practice (No. 65 of […]
PV Safety Databases
PV Safety Databases ArisG Safety Database ArisG uses artificial intelligence to automate case processing, facilitate decision-making and make safety workflows more efficient. It is a cloud-based solution that allows for easy updating to new regulatory standards and global PV teams to operate in one real-time system. You can visualize reporting measures and quickly generate compliance […]
FAQs
FAQs Case Reporting (ICSR Reporting) What are the requirements for reporting overseas adverse drug reactions (ADRs) in pharmacovigilance? According to the Provision for Adverse Drug Reaction Reporting and Monitoring (Order No.81 of the Ministry of Health), for Serious adverse drug reactions (including those collected by the spontaneous reporting system, those found in post-marketing clinical studies […]
China Pharmacovigilance History
China Pharmacovigilance History Pharmacovigilance in China: Milestones and Advancements China pharmacovigilance regulatory reform has a history dating back to 1980’s with the building of ADR monitoring networks in China to more significant evolution after China joined ICH in 2017 which is now the foundation and commitment towards an internationally harmonised PV system. China strengthened pharmacovigilance […]
China’s Good Pharmacovigilance Practices (GVP)
China’s Good Pharmacovigilance Practices (GVP) An essential Guide to China’s Good Pharmacovigilance Practices (GVP) China’s National Medical Products Administration (NMPA), formerly knownasCFDA, released the China Good Pharmacovigilance Practice (GVP)guidelines in May 2021. These China GVP guidelines are designed to improveand align China’s pharmacovigilance regulations and practices withinternational standards set by the International Council for Harmonization(ICH).The […]