Pharmacovigilance and drug safety remains a dynamic clinical and scientific discipline. KeywordsĪdverse drug reaction, pharmacovigilance, international classification of disease, FDA adverse event reporting system, eudravigilance Abbreviation:ĪDR: Adverse Drug Reaction USFDA: United States Food and Drug Administration FDA: Food and Drug Administration FAERS: FDA Adverse Event Reporting System WHO: World Health Organization PMS: Post Marketing Surveillance ICH: International Conference on Harmonization ICD: International Classification of Disease ICDA: International Classification of Disease Adapted ICPM: International Classification of Procedures in Medicines SRS: Spontaneous Reporting System EMA: European Medicine Agency EU: European Union EEA: European Economic Area PRAC: Pharmacovigilance Risk Assessment Committee CHMP: Pharmacovigilance Risk Assessment Committee UMC: Uppsala Monitoring Centre EMEA: European Medicines Evaluation Agency Introduction European Union drug regulating authorities Pharmaco vigilance (Eudra Vigilance) is the European data processing network management system for reporting and studying the suspected adverse reaction during new drug development. FDA Adverse Event Reporting System (FAERS) and the data available always require substantial duration before using and various strategy are applied for cleaning the data. In United States of America U.S Food and Drug Administration (FDA) helps to study and find the adverse drug reaction data in the system and this data is publically available. The spontaneous reporting of ADR and using collected data related every product is used for hypothesis generation and also for validation of new approaches. ADR identification is needed for the surveillance of drug safety.
2 Guru JambheshwarUniversity Science and Technology, Haryana, India Corresponding Author: Kavita BahmaniĪdverse Drug Reaction (ADR) identification is the most important goal during the post marketing phase.