The Medicines and Healthcare products Regulatory Agency (MHRA) have introduced pack size restrictions, age warnings and new safety warnings on labelling of over-the-counter (OTC) stimulant laxatives such as bisacodyl and senna. Read more “New measures to support safe use of stimulant laxatives”
Category: PV
Keep up to date with the latest pharmacovigilance news in the pharmaceutical and regulatory affairs industry.
Post-transition guidance from the MHRA: Pharmacovigilance, QPPV and PSMF
On 01 September 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) laid out the future UK requirements for submission of pharmacovigilance data at the end of the Brexit Transition period, as well as guidance on the qualified person responsible for pharmacovigilance (QPPV) and pharmacovigilance system master files (PSMF). Read more “Post-transition guidance from the MHRA: Pharmacovigilance, QPPV and PSMF”
EU agencies clarify PV expectations during pandemic
A joint question and answer (Q&A) document features three new questions related to pharmacovigilance (PV). Read more “EU agencies clarify PV expectations during pandemic”
An update from the EMA EudraVigilance Registration Manual
The EudraVigilance XCOMP Test System has been aligned with Production in an update to the Registration Manual. Read more “An update from the EMA EudraVigilance Registration Manual”
New PV inspection follow-up procedures in the EU
The European Medicines Agency (EMA) have explained EU wide follow-up procedures for pharmacovigilance (PV) inspections in a 15-page guidance. Read more “New PV inspection follow-up procedures in the EU”
Regulators issue warnings for use of malaria drugs for COVID-19
Chloroquine and hydroxychloroquine have been touted as potential treatments for COVID-19 patients, however clinical data is still very limited and the beneficial effects of these medicines in COVID-19 have not been demonstrated. Read more “Regulators issue warnings for use of malaria drugs for COVID-19”
COVID-19 impact on Pharmacovigilance
Here is a roundup of the impact of the current pandemic on global pharmacovigilance (PV) practices in both clinical trials and post-marketing. Read more “COVID-19 impact on Pharmacovigilance”
New appointments in our PV team…
We are very pleased to introduce two new members of our PV team.
FDA guidance on adverse event reporting during a pandemic
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”
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”