EMA’s PRIME draft toolbox: Consultation ends July 2021

Action required: Consultation for the EMA PRIority MEdicine (PRIME) draft toolbox guidance closes 31st July 2021. What is PRIME about? The European Medicines Agency (EMA) launched the PRIority MEdicines (PRIME) scheme in March 2016. The scheme was launched to provide early and enhanced scientific and regulatory support for medicines that target an unmet medical need. …

FDA Adverse Event Reporting System (FAERS)

FDA launches FAERS public dashboard for COVID-19 emergency use authorization products. Covid-19 is currently in the news worldwide and that on a daily basis. With vaccinations now becoming more widely available, not only healthcare professionals are interested in post vaccination information. The public too is getting hungrier not only for information on vaccination success, but …

Machine Learning for the benefit of Life Sciences

Machine Learning (ML) is a form of Artificial Intelligence (AI), allowing applications to learn from the data processed. This is in contrast to programming, which follows a defined route to write a specific computer program. During the absorption of data, the ML algorithms learn to produce better, more precise ‘models’. These ML ‘models’ are an …

UK spearheading Pathway for faster Time to Market

The UK is spearheading a new initiative on how innovative medicinal products can be brought to market faster and therefore made accessible to patients more quickly. In December 2020, the MHRA released new guidance documents on ILAP or Innovative Licensing and Access Pathway to clarify new opportunities for stakeholders in medicinal product development. Already operational, …

EMA provides latest on Article 57

Action required before end of January 2021. Since 1 February 2020, when the United Kingdom withdrew from the European Union (EU), the UK has become a ‘third country’ as far as the EU is concerned. A withdrawal agreement has provided direction for the transition period, ending 31 December 2020 (European Commission, Notice to Stakeholders, 13 …