Pharmacovigilance is the ongoing monitoring of the safety of medicines after they are authorised, and the set of activities used to detect, assess, understand, and prevent adverse effects. In the European Union it is coordinated by the European Medicines Agency and national competent authorities, supported by the EudraVigilance database of suspected adverse reactions. Marketing authorisation holders must operate a pharmacovigilance system, submit periodic safety update reports, run signal detection, and carry out risk management planning. When a safety signal is confirmed, regulators can update product information, restrict use, or withdraw a product. Pharmacovigilance is a core part of the pharmaceutical regulatory lifecycle because a medicine's full safety profile only emerges once it is used in large and diverse patient populations in real-world conditions.
What is pharmacovigilance?
Pharmacovigilance is the science and activity of detecting, assessing, and preventing adverse effects and other problems related to medicines.
Who is responsible for pharmacovigilance in the EU?
Responsibility is shared between the European Medicines Agency, national competent authorities, and marketing authorisation holders, who must operate their own pharmacovigilance systems.
Updating of the information sheet Guidance for Industry on the electronic exchange of ICSRs in E2B(R3) format through B2B gateway
Updated guidance on electronic exchange of individual case safety reports in E2B(R3) format via B2B gateway.
Swissmedic · SwitzerlandEstablishment of a Quantitative Medicine Innovation Network: Scope, Feasibility, and Opportunities; Request for Information
FDA CDER requests feedback on developing a cross-sector collaborative platform to advance quantitative medicine approaches in drug development and regulatory science.
US Federal Register - FDA Notices · United StatesSpecial Registrations for Telemedicine and Limited State Telemedicine Registrations
DEA establishes Special Registration framework for telemedicine practitioners to prescribe controlled substances without in-person evaluation, with heightened recordkeeping and reporting requirements.
US Federal Register - DEA Telehealth Rules · United StatesEuropean Biotech Act: amendments 2802–2985 to draft report on strengthening Union biotechnology and biomanufacturing sectors
Parliamentary amendments to draft legislation establishing a framework for strengthening EU biotechnology and biomanufacturing, amending food, ATMP, clinical trials, veterinary, and related regulations.
European Parliament - SANT Subcommittee (Public Health) · EU-wideEuropean Biotech Act: amendments 2522–2801 to draft report on strengthening Union biotechnology and biomanufacturing sectors
Parliamentary amendments to draft legislation establishing a framework for strengthening EU biotechnology and biomanufacturing, amending food, ATMP, clinical trials, veterinary, and related regulations.
European Parliament - SANT Subcommittee (Public Health) · EU-wideM15 General Principles for Model-Informed Drug Development; ICH Guidance for Industry
FDA finalizes ICH M15 guidance on model-informed drug development planning, evaluation, documentation, and regulatory submission.
US Federal Register - FDA Guidance Notices · United StatesDrug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities—Questions and Answers; Revised Draft Guidance for Industry
Revised draft guidance on manufacturer communications of health care economic information about approved drugs and devices to payors and formulary committees.
US Federal Register - FDA Guidance Notices · United StatesBiosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts; Draft Guidance for Industry
FDA draft guidance on developing container closure systems and device constituent parts for biosimilar and interchangeable biosimilar products.
US Federal Register - FDA Guidance Notices · United States