The Medicines and Healthcare products Regulatory Agency (MHRA) has detailed the registration process for submitting applications and reports through national portals. Read more “Detailed guidance on the electronic submission process for applications to the UK”
Category: PV
Keep up to date with the latest pharmacovigilance news in the pharmaceutical and regulatory affairs industry.
EMA publishes second issue of their Clinical Trials Information System (CTIS) Highlights newsletter
The Clinical Trials Regulation (EU) 536/2014 was implemented to harmonise the process of conducting and monitoring clinical trials across the European Union (EU) whilst simultaneously improving transparency. The December 2020 CTIS highlights newsletter covers the key features and future developments in the CTIS. Read more “EMA publishes second issue of their Clinical Trials Information System (CTIS) Highlights newsletter”
The latest MHRA guidance surrounding clinical trials and Brexit
The Medicines and Healthcare Products Regulatory Agency (MHRA) has released their latest guidance on conducting clinical trials for investigational medicinal products (IMP) after the transition period. It sets out requirements for the registration, publication of summary results and amendments to clinical trials, as well as submitting clinical trial safety reports. Read more “The latest MHRA guidance surrounding clinical trials and Brexit”
MHRA reveal new Brexit guidance on QPPV and PSMF requirements
As of 31 December 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) have published new guidance on the qualified person responsible for pharmacovigilance (QPPV) and the pharmacovigilance system master files (PSMF) for existing marketing authorisation holders (MAH) in the United Kingdom (UK) in light of Brexit. Read more “MHRA reveal new Brexit guidance on QPPV and PSMF requirements”
MHRA release guidance on submitting clinical trial safety reports from 1 January 2021
How to submit Suspected Unexpected Serious Adverse Drug Reactions (SUSARs) and annual safety reports Development Safety Update Reports (DSURs) at the end of the Brexit transition period. Read more “MHRA release guidance on submitting clinical trial safety reports from 1 January 2021”
EMA publishes advice on Northern Ireland post-transition
The EMA have published a new question and answer guidance on the implementation of the Protocol on Ireland / Northern Ireland. Read more “EMA publishes advice on Northern Ireland post-transition”
MHRA update on Northern Ireland country code from 01 January 2021
In an update to their guidance on pharmacovigilance procedures post-Brexit transition, the Medicines and Healthcare products Regulatory Agency (MHRA) has added content covering country codes for Individual Case Safety Report (ICSR) submissions. Read more “MHRA update on Northern Ireland country code from 01 January 2021”
EMA lays out COVID-19 vaccine pharmacovigilance plan
The European Medicines Agency (EMA) has laid out its COVID-19 pharmacovigilance vaccine safety monitoring plan, as it continues a rolling review of vaccine candidates. Read more “EMA lays out COVID-19 vaccine pharmacovigilance plan”
Revised guidance on ICSRs in the context of COVID-19
The European Medicines Agency (EMA) have updated their guidance on the validity and coding of Incident Case Safety Reports (ICSR) in the context of COVID-19 related terms. Read more “Revised guidance on ICSRs in the context of COVID-19”
New measures to support safe use of stimulant laxatives
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”