EMA’s SME Office 2023 Annual Report
We're excited to announce the publication of the EMA SME Office's 2023 annual report. This document outlines the Office's functions and their alignment with the needs of European small and…
We're excited to announce the publication of the EMA SME Office's 2023 annual report. This document outlines the Office's functions and their alignment with the needs of European small and…
The concept paper on phage therapies for human health goal is to establish a scientific guideline for the pharmaceutical development and manufacture of bacteriophage medicinal products intended for the therapeutic…
Today, from Revio, we would like to share with you the latest updates on the scientific recommendations that European Medicines Agency’s Committee for Advanced Therapies (CAT) delivers on whether a…
Today, from Revio, we would like to inform you that the European Medicines Agency recently published for public consultation a draft Guideline on core SmPC, Labelling and Package Leaflet for…
Today, from Revio, we would like to share with you a summary of the main aspects mentioned in the EMA ‘’Reflection paper on stem cell-based medicinal products’’ (EMA/CAT/571134/2009) which may…
Challenges to design and conduct ATMP trials Manufacturing constraints and short shelf-life may require the implementation of tight controls on logistical arrangements. Mode of application may imply difficulties in the…
ATMPs classification procedure There is a “Reflection paper on classification of advanced therapy medicinal products” (21 May 2015, EMA/CAT/600280/2010 rev.1) with the aim of: Providing guidance on the ATMPs classification…