European Medicines Agency (EMA) recently published an open consulation about the evaluation of anticancer medicinal products. The concept paper anticipates that EMA considering to change the current assessment procedure from indication (location) based approval to the pathological mechanism approach. For details please check the original document: https://www.ema.europa.eu/documents/scientific-guideline/concept-paper-revision-guideline-evaluation-anticancer-medicinal-products-man_en.pdf The partial implementation of this new approach had […]

Marketing Authorization Transfer (MAT) can cause seriuos extra workload on every related departments. As a consequence sometimes there is not enough time to ensure tha cross-departmental communication flows efficiently and important details can be missed out. Most of the administrative work is done by the Legal and Regulatory Departments but clear communication among Pharmacovigilance and […]