Company News

Most of pharmaceutical companies plan to submit IDMP data through a dedicated software tool. Hence, the choice of this software is determinant. For those companies that have not made their choice yet, we realized an assessment of some of the IDMP solutions available in the...

ISO IDMP Timelines and Iteration Both the European Medical Agency (EMA) and the Food and Drugs Administration (FDA) are in the process of implementing the standards developed by the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP). Following a phased implementation process, pharmaceutical...

New Clinical Data Publication Policy The European Agency proactively publishes the clinical reports submitted under the centralized marketing authorization procedure for human medicines. The policy entered into force on 1 January 2015 and is currently being implemented. The philosophy of this new Clinical data publication policy is in contradiction...