Among the measures unveiled in the UK government’s Autumn Statement, published on 17 November 2022, Chancellor of the Exchequer Jeremy Hunt said that there will be regulatory reform to encourage economic growth in key industries, including the life sciences.
Pharmacovigilance (PV) – the proactive maintenance of drug safety through collection, detection, assessment, monitoring and prevention of adverse effects – has been evolving since the first concerns were raised over the negative effects of chloroform anaesthetic in the 1800s. Today, it is just as important that pharma, start-ups and regulators keep up to date with the latest trends to ensure that drugs are safe and monitoring practices remain fit for purpose.
Wellcome has awarded £1.8m to the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) so that they can investigate and produce guidance on regulation of digital mental health tools.
The National Institute for Health and Care Excellence (NICE) plans to speed up its processes for evaluating lower-risk treatments using a lighter touch approach. This will free up time to consider the increasing number of more complex applications. NICE states that this method will make its assessments faster, enabling quicker access to promising new treatments.
The European Medicines Agency and the Heads of Medicines Agencies in the EU Member States are advancing their agenda to improve data quality for medicine regulation decision-making, publishing the draft Data Quality Framework and a draft good practice guide for the use of the EU metadata catalogue of real-world data sources for consultation this month. Read more.
PharmaMedic is delighted to announce our next virtual event on Thursday 28th October 2021 at 8 am. As the UK life sciences sector continues its journey outside the EU, it’s time to forge a new role in the international community. This briefing will highlight some of the critical considerations we face from both innovation and regulatory perspectives. Learn more about the agenda and register here.
