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”
Year: 2019
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”
Celebrating success
One of our PV team, Daniel Mullins celebrated his graduation as a Master of Science in Immunology of Infectious Diseases in London last week.
A fantastic achievement and a huge well done from the rest of the team at Regulis!
Making submissions to the MHRA if the UK leaves the EU without a deal
The Medicines and Healthcare Products Regulatory Agency (MHRA) are making preparations to ensure that if the United Kingdom (UK) does leave the European Union (EU) with no deal, companies can continue to submit regulatory and notification information to the UK. Currently the only areas enabled on the MHRA Submissions home page are the User Maintenance and Pharmacovigilance Gateway Management. Read more “Making submissions to the MHRA if the UK leaves the EU without a deal”
Highlights from the February CHMP meeting
From their meeting in February, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. During the meeting the CHMP announced the recommendations of eight medicines for approval, including two orphan medicines. For three out of the eight new medicines, the CHMP recommended a conditional marketing authorisation. Read more “Highlights from the February CHMP meeting”
EMA publishes first series of EU MDR/IVDR guidance
The European Medicines Agency (EMA) has published the first of a series of guidance documents to help applicants prepare for the implementation of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). The involvement of a Notified Body (NB) in a medicinal product with an integral medical device is the focus of the first EMA guidance related to the new European Union (EU) MDR. Read more “EMA publishes first series of EU MDR/IVDR guidance”
EMA provides procedural update on submission of Type 1 variations in March, April and May 2019
The European Medicines Agency (EMA) is encouraging Marketing Authorisation Holders (MAHs) who intend to submit Brexit-related Type IA and Type IB variations in March 2019, to submit these variations as soon as possible during the month. This will ensure that the EMA can process the submissions before 29th March, so that MAHs can receive confirmation of compliance with the regulatory and legal requirements before the United Kingdom (UK) leaves the European Union (EU). Read more “EMA provides procedural update on submission of Type 1 variations in March, April and May 2019”
European Commission provides update on post-Brexit batch testing requirements
A letter to the European Medicines Agency (EMA) and EU27 Heads of Medicines Agencies (HMA), written by the European Commission’s Directorate-General for Health and Food Safety (Sante), outlines an exemption to certain batch testing requirements for medicine manufacturers who currently perform batching test in the United Kingdom (UK). Read more “European Commission provides update on post-Brexit batch testing requirements”
European Union advances towards adopting SPC waiver proposal
The European Union (EU) is adopting new rules which aim to increase the competitiveness of EU producers of generic medicines and biosimilar products. The EU’s proposal to allow manufacturing waivers to supplementary protection certificates (SPC) advances after EU ambassadors approved a compromise that was reached on 14th February with the European Parliament during a meeting of the Committee of the Permanent Representatives. Read more “European Union advances towards adopting SPC waiver proposal”