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…
EMA’s concept paper on phage therapies for human health
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…
Advice on regulatory procedures for ATMPs that may be used during development (III): Stem cell-based medicinal products
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…
Advice on regulatory procedures for advanced therapy medicinal products that may be used during the development (I)
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…
