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”
Category: PV
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”
EMA finalises guideline on GVP considerations for paediatric populations
The European Medicines Agency (EMA) has finalised their recently adopted guideline on good pharmacovigilance practices (GVP) module which provides recommendations for pharmacovigilance in paediatric populations. Read more “EMA finalises guideline on GVP considerations for paediatric populations”
TGA opens consultation on use of boxed warnings to highlight safety issues
The Therapeutic Goods Administration (TGA) Australia has opened a consultation on guidance regarding the use of boxed warnings used to highlight serious safety issues. The guidance outlines the objectives for introducing a boxed warning to a Product Information (PI) document, and provides advice on how and when to use a boxed warning. The aim is to ensure consistency across the prescription medicines regulatory framework. Read more “TGA opens consultation on use of boxed warnings to highlight safety issues”
EMA clarifies MAH obligations to record adverse events accessed through EudraVigilance
The European Medicines Agency (EMA) has published a note which clarifies the pharmacovigilance obligations of marketing authorisation holders (MAHs). The note provides information about when MAHs must record information regarding adverse events they access via EudraVigilance. Read more “EMA clarifies MAH obligations to record adverse events accessed through EudraVigilance”
MHRA releases guidance for submission of educational material
The Medicines and Healthcare Products Regulatory Agency (MHRA) has issued guidance on how marketing authorisation holders (MAHs) should provide educational materials to the MHRA for assessment and approval prior to launching their products on the United Kingdom (UK) market. Read more “MHRA releases guidance for submission of educational material”