The US Food and Drug Administration (FDA) have published an updated guidance on post-marketing adverse event reporting for medical products and dietary supplements during a pandemic. Read more “FDA guidance on adverse event reporting during a pandemic”
Category: PV
Pharmacovigilance news and updates
Improving patient safety through integrated Yellow Card reporting
93% of GP practices in the UK will now be able to use their clinical IT system for integrated Yellow Card reporting of suspected adverse drug reactions (ADR) to the Medicines and Healthcare products Regulatory Agency (MHRA). Read more “Improving patient safety through integrated Yellow Card reporting”
Did you know the ISO adverse drug reaction reporting format will be mandatory by June 2022
The European Medicines Agency’s (EMA) management board has agreed to make the International Organisation for Standardisation’s (ISO) individual case safety report (ICSR) format mandatory for suspected adverse drug reaction (ADR) reporting to EudraVigilance. Read more “Did you know the ISO adverse drug reaction reporting format will be mandatory by June 2022”
Pilot for Reporting Illicit Drug Reactions to be discontinued
Public Health England (PHE) have decided to close the 2017 Reporting Illicit Drug Reactions (RIDR) pilot programme by 28 February 2020. Read more “Pilot for Reporting Illicit Drug Reactions to be discontinued”
A 4-year overview of pharmacovigilance activities in the EU
A report carried out by the European Medicines Agency (EMA) in collaboration with national competent authorities of European Union (EU) Member States, has shown that the EU pharmacovigilance (PV) system is robust and effective at ensuring the safety of medicines. Read more “A 4-year overview of pharmacovigilance activities in the EU”
The projected changes to pharmacovigilance in the next decade
A recent article published by the European Medicines Agency (EMA) in “Clinical Pharmacology and Therapeutics”, predicts the outlook for pharmacovigilance (PV) in 2030. Read more “The projected changes to pharmacovigilance in the next decade”
A report on the experience of monitoring medicines under the EU Black Triangle scheme
The European Commission (EC) had published a report for the European Council, on the European Medicines Agency’s (EMA) and Member States’ (MS) experiences of monitoring the safety of medicines that are subject to additional monitoring. Read more “A report on the experience of monitoring medicines under the EU Black Triangle scheme”
How does the EMA plan to improve the quality of pharmacovigilance reporting systems for ADRs?
The regulatory drive to increase the amount of data and improve the quality of pharmacovigilance (PhV) reporting systems is key to maintaining the databases at the forefront of signal detection. Read more “How does the EMA plan to improve the quality of pharmacovigilance reporting systems for ADRs?”
Introducing a new form for drug safety signals regarding human medicinal products
The Swiss Agency of Therapeutic Products (Swissmedic) has created a new Signal Notification Form as part of its plan to make safety data collection more efficient. Read more “Introducing a new form for drug safety signals regarding human medicinal products”
The FDA plans to implement e-submission of safety reports for investigational new drug (IND) applications
The United States (US) Food and Drug Administration (FDA) is taking steps towards making electronic submission of safety reports for investigational new drug applications (INDs) into their Adverse Event Reporting System (FAERS), a requirement. Read more “The FDA plans to implement e-submission of safety reports for investigational new drug (IND) applications”