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”
Category: PV
Pharmacovigilance news and updates
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”
Highlights from the recent PRAC meeting
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) have unveiled highlights of their meeting from 30th September – 3rd October 2019. Read more “Highlights from the recent PRAC meeting”
MHRA provides update on pharmacovigilance system requirements if there is a no-deal Brexit
The Medicines and Healthcare products Regulatory Agency (MHRA) have updated their guidance on the qualified person responsible for pharmacovigilance (QPPV) including the pharmacovigilance system master files (PSMF) in a no-deal Brexit. Read more “MHRA provides update on pharmacovigilance system requirements if there is a no-deal Brexit”
FDA finalises postmarketing safety reporting requirements guidance for combination products
The United States (US) Food and Drug Administration (FDA) have finalised guidance which details the postmarketing safety reporting (PMSR) requirements for combination products and their constituent parts. Read more “FDA finalises postmarketing safety reporting requirements guidance for combination products”