Recently, the European Medicines Agency (EMA) released a draft guidance to assist on scientific elements and regulatory tools to support quality data packages for PRIME marketing authorisation applications.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…
Liability accounts show what a company owes, like loans and accounts payable. We are surrounded by business – from managing our own money to seeing profit statements of big corporations.…
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…
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…