New EMA veterinary product information template

Action required: The EMA invites comments for the new product information template by 14/May/2021. The EMA just released a new product information template for public consultation. Besides smaller adjustments, the template mainly addresses changes required in line with the New Veterinary Regulations (NVR) that is coming into effect January 2022. Although no firm date for …

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 …

New EMA’s Union Product Database production release

The EMA released version 01.02 of the Union Product Database on 16th March 2021. As part of the New Veterinary Regulations (NVR) implementation, the EMA is developing a Union Product Database (UPD) to allow the management of veterinary medicinal products in the EU. The UPD has been welcomed by many and will certainly improve the …

EMA’s Union Product Database user research

Union Product Database: EMA’s Veterinary Medicines Division released user research. In January 2021, the EMA released some interesting findings about how stakeholders might want to make use of the Union Product Database (UPD). What is the UPD? According to the New Veterinary Regulations (NVR) EU 2019/6, the European Medicines Agency (EMA) shall establish and maintain …

EMA’s Union Product Database implementation guide updated (again!)

Action required: Union Product Database implementation guide is available for consultation until 21/March/2021. Today, I shall look at three of the many changes proposed. The first important update. Under the New Veterinary Regulations (NVR) EU 2019/6, the European Medicines Agency (EMA) shall establish and maintain a Union Product Database (UPD). In previous blogs we looked …

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, …

UPDated – EMA updated Union Product Database implementation guide

According to the New Veterinary Regulations (NVR) EU 2019/6, the European Medicines Agency (EMA) shall establish and maintain a Union Product Database (UPD). In July 2020 the EMA published the UPD access policy (EMA/198149/2020), which outlines who gets access to which data stored in the UPD. It outlines how all parties can meet their obligations …