Rapid implementation of the revised sartan monographs on 1 April 2021 Nitrosamines are chemical compounds classified as probable human carcinogens on the basis of animal studies. The review of sartans concerned candesartan, irbesartan, losartan, olmesartan and valsartan, which belong to a class of medicines called sartans (also known as angiotensin-II-receptor antagonists). These sartan medicines have […]
There are now several routes to obtain a marketing authorisation in the United Kingdom (UK), Great Britain (England, Scotland and Wales) or Northern Ireland. The options available will be determined by the intended market and the type of application. In this article we will discuss the purely National procedure. To help you to decide what type of […]
Ivowen wishes to announce that our beloved founder Majella Ryan has decided to retire this year. She co-founded the company in 2002 and has spent the past 19 years working tirelessly to establish Ivowen as a no-nonsense, hardworking, one stop shop for practical regulatory solutions. Although we are sad […]
I am sure you will agree that 2020 has been a very trying year for all of us. Despite the restrictions, politics and challenges of working from home the regulatory world keeps on spinning. Check back in January for the latest updates from our amazing team This year, in lieu of Christmas gifts for staff […]
The UK has left the EU and the transition period after Brexit comes to an end this year. The MHRA have issued new guidance for industry and organisations effective from 01st January 2021. From this date the MHRA will be the UK’s standalone medicines and medical devices regulator. Areas covered in the new guidance include: […]
Following the outcome of the Article 31 referral on sartans with a tetrazole ring and the knowledge acquired on N-nitrosamines in medicinal products, EMA together with the EU Network and international partners has continued the review to identify if there are any consequences for medicinal products outside the class of sartans. Taking into account that […]
In 2018 the EMA had a public consultation (15th Nov 2018 – 15th May 2019) on draft guidance for industry on the pharmaceutical use of different grades of water in the manufacture of active substances and medicinal products. This consultation has resulted in an update to the old 2002 guidelines and the new guideline will […]
It seems that Brexit is on course for 1st January 2021…. The 30th June 2020 came and the legal deadline for agreeing to an extension of the transition period has passed with no request from the UK. Therefore the Brexit trade deal transition phase will come to an end on the 31st December 2020. At […]
Where does the time go… Happy Birthday to Ivowen. Thanks to all our super team members, past and present – and future! And of course our many valued and loyal clients and customers, whom we are also privileged to call friends. We wouldn’t be here without any of you, and we raise a socially distanced […]
Did you know, that pharmaceutical companies can consult the European Medicines Agency (EMA) to determine whether a medicine they are developing is considered an advanced therapy medicinal product (ATMP)? In doing so, they are allowed to receive confirmation that a medicine, which is based on genes, cells or tissues, meets the scientific criteria for defining an […]
In response to the significant impact the COVID-19 pandemic is having on European regulatory activity, the European Commission, the European Medicines Agency and the Heads of Medicines Agencies network (EC, EMA and HMA, respectively) have approved a number of measures to help the management of marketing authorisations for human medicinal products considered crucial during the pandemic period. The objective […]
The European Medicines Agency (EMA) has recently published an overview of pharmacovigilance activities that outlines just how strong and reliable a system we have in the EU. The report was prepared by EMA in collaboration with the National Competent Authorities (NCA). The report includes quantitative data covering the period between 2015 and 2018 and shows […]
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