Today, from Revio, we would like to share with you a review of the Industry Guidance on manufacturing of cellular and gene therapy products (CGT) authorised by the Food and…
Today, from Revio, we would like to share with you a summary of the Reflection paper on clinical aspects related to tissue engineered products (EMA/CAT/573420/2009) adopted 19 September 2014.Tissue engineered…
In November 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a revision on the EMA’s Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically…
European Medicines Agency (EMA) has recommended granting a marketing authorisation in the EU for the gene therapy Skysona (elivaldogene autotemcel). Skysona is currently pending for European Commission decision.Skysona is indicated…
Recently, the European Medicines Agency (EMA) released a draft guidance to assist on scientific elements and regulatory tools to support quality data packages for PRIME marketing authorisation applications. This guidance…
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…
The global effort on fighting the on-going COVID-19 pandemic, declared so by the World Health Organization in 11 March 2020, is bearing fruit. The endeavor made in the last year…
Medicinal Products development is a long, complex and expensive process. It could take at least 10 years before the product can be marketed.From Revio, we would like to share with…
In January 2018 the EMA released for consultation the Guideline on safety and efficacy follow-up and risk management of Advanced Therapy Medicinal Products (Rev.1). This guideline is still in draft…
Developers of Advanced Therapy Medicinal Products (ATMPs) need to be aware of the legislation that is applicable to different stages of the process. In addition, the European Commission published in…
Revio is a Regulatory Affairs Consultancy – Created to support biopharmaceutical companies and public institutions, working with Advanced Therapy Medicinal Products (ATMPs)