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”

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”

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”

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”