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We invite you to follow our subject matter experts as they share useful information about key industry regulations along with insights about how organizations are improving the efficiency of regulatory operations information management.

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

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 …

UP-to-Date

What is the UPD? According to the New Veterinary Regulations (NVR) EU 2019/6, the European Medicines Agency (EMA) shall establish and maintain a Union Product Database (UPD). With that in mind, implementation acts are required laying out electronic exchange mechanism and data format, database functionality and interface/API as well as detailed specifications of the data …