Last month, the Taskforce on Innovation, Growth and Regulatory Reform (TIGRR) report was published, giving its recommendations to the Prime Minister on how the UK can reshape its approach to regulation and seize new opportunities from Brexit.
JensonR+ Regulatory Officer, Ben Smith talks through a bitesize overview of the latest MHRA Post-Transition Guidance in this helpful video.
BREXIT will affect the pharmaceutically industry greatly and with an exit date of 31/12/2020 it is important that you are aware of all the changes that will take place - there are a lot of important dates and pressure points that you need to be aware of.
150 Days to the End of the Transition Period: A Focus on Centrally Authorised Products Today marks 150 days until the end of the UK-EU transition period; on the 1st January 2021 the UK will no longer be in the EU single market and customs union. Following on from our post about the possible [...]
EMA soon to publish updated guidance on Nitrosamine Impurities The EMA’s human medicines committee (CHMP) has now issued an opinion regarding the maximum limits of nitrosamines in medicines and the measures required by pharmaceutical companies to reduce the presence of these carcinogenic impurities. As captured in our 2019 posts regarding nitrosamines and the considerations [...]
Deadline Looms for the Safe Labelling of Excipients in Medicines In October 2017, the EMA and European Commission updated the annex to excipient guidelines for new safety advice of 15 excipients and the three-year timeline to implement the change is nearly over. Excipients are considered to be the ‘inactive’ [...]
Making sense of the regulatory landscape in the UK and Europe This year marks the 10-year anniversary since eCTD became mandatory for all submissions to the EMA for Centrally Authorised Products, meaning all these products have eCTDs hosted by the EMA. After the transition period on the 31st December 2020, the MHRA will [...]
MHRA Regulatory Flexibilities during the COVID-19 Pandemic In the wake of the on-going fallout from the COVID-19 pandemic, the MHRA has been active in taking steps to lessen the regulatory burden on companies working on issues central to the fight against COVID-19. Since the first publication of the guidance on [...]
EMA Provide Advice on Regulatory Expectations and Flexibility during the COVID-19 Pandemic In the wake of the on-going COVID-19 pandemic, the EMA has published a Question and Answers document which provides guidance to stakeholders on the implemented adaptations to regulatory framework that have been put in place to address some of the unprecedented challenges [...]