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”
Category: PV
Pharmacovigilance news and updates
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”
FDA further delays compliance date for postmarketing safety reporting requirements for combination products
After pushing back the date by which combination product companies must comply with certain postmarketing safety reporting (PMSR) requirements, the United States (US) Food and Drug Administration (FDA) have further delayed the compliance deadline by a year. Read more “FDA further delays compliance date for postmarketing safety reporting requirements for combination products”
MHRA releases guidance on how to manage safety reporting in a blinded trial
The Medicines and Healthcare Products Regulatory Agency (MHRA) have written a blog to clarify their expectations regarding the unblinding and reporting of serious adverse reactions (SARs) associated with comparator medicines. Read more “MHRA releases guidance on how to manage safety reporting in a blinded trial”
How to submit ICSRs and SUSARs to the MHRA if the UK leaves the EU with no-deal
The Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance for all pharmaceutical companies involved in the submission of Individual Case Safety Reports (ICSRs) or Suspected Unexpected Serious Adverse Reactions (SUSARs) in the event of a no-deal Brexit. Read more “How to submit ICSRs and SUSARs to the MHRA if the UK leaves the EU with no-deal”
Regulis attends 18th Pharmacovigilance 2019 conference
The Regulis Pharmacovigilance team were delighted to attend and exhibit at the 18th Annual Pharmacovigilance 2019 in London last month. Senior Pharmacovigilance Executive Pavan Bamrah said “we had a great couple of days with thought-provoking presentations and lots of interesting conversations with colleagues”. Read more “Regulis attends 18th Pharmacovigilance 2019 conference”
Regulis signs agreement with ArisGlobal
We are always looking for ways to improve services to our clients and we are therefore delighted to share some exciting news! We have engaged a new Safety Database Provider; we will be working together with ArisGlobal! Read more “Regulis signs agreement with ArisGlobal”
ABPI revises guidance for Pharmacovigilance in Market Research
The Association of the British Pharmaceutical Industry (ABPI) and the British Healthcare Business Intelligence Association (BHBIA) have produced a revised version of their guidance on collecting adverse events, product complaints and special situation reports during market research programmes (MRPs). The guidance document was first issued in October 2009, and is now version 4, which took effect from the beginning of October 2018. Read more “ABPI revises guidance for Pharmacovigilance in Market Research”