Pharmacovigilance Resources & Regulatory Guidance
The following resources represent a selection of internationally recognised regulatory and scientific references relevant to Clinical Development, Clinical Safety and Pharmacovigilance.
EMA – Good Pharmacovigilance Practices
The central European source for current GVP modules, annexes and product- or population-specific pharmacovigilance guidance.
European Medicines Agency – Good Pharmacovigilance Practices
EMA – Risk Management Plans (RMPs)
Official EMA information on the content, preparation and use of risk management plans, including safety concerns, pharmacovigilance activities and risk-minimisation measures.
European Commission
Information on the European legal framework governing the monitoring and management of medicinal-product safety.
Pharmacovigilance Risk Assessment Committee (PRAC)
Heads of Medicines Agencies
Pharmacovigilance information and regulatory resources from the network of national medicines authorities in the European Economic Area.
European ADR Reports
Public access to aggregated reports of suspected adverse reactions submitted to the European EudraVigilance system
Uppsala Monitoring Centre – WHO Collaborating Centre for International Drug Monitoring
The WHO Collaborating Centre supporting global pharmacovigilance through scientific methods, international safety data, research, training and analytical tools.
CIOMS
International working-group reports and recommendations covering signal management, benefit–risk assessment, risk minimisation and other pharmacovigilance topics.
MedDRA
The official source for the internationally standardised medical terminology used to code, retrieve, analyse and communicate regulatory safety information.
ICH
The official collection of ICH efficacy guidelines, including the E2 series covering clinical safety-data management and pharmacovigilance reporting.
ECDC /BfArM
European public-health information on vaccination programmes, vaccine-preventable diseases, epidemiological surveillance and immunisation policy.
Paul-Ehrlich-Institut – Pharmacovigilance
Official information on pharmacovigilance and medicinal-product safety, particularly for vaccines and biomedicinal products.