Even for centrally approved products, each European country is responsible for the effective
national market access. This step can result in inequalities in terms of access, due to …

Advanced therapy medicinal products (ATMPs) are potential game changers in modern
medical care with an anticipated major impact for patients and society. They are a new drug …

Background: The umbrella term ATMPs (Advanced Therapy Medicinal Products) comprises
cell therapies, gene therapeutics and tissue engineered products. After implementation of …

Advanced therapy medicinal products (ATMPs) are a fast-growing field of medicine with
wide potential application. Nevertheless, so far, only 19 have obtained European Union …

Highlights•Relevant quality issues were raised in all assessment procedures.•Lack of
efficacy and severe safety risks were decisive for non-approval.•Experimental characteristics …

Background: Advanced therapy medicinal products (ATMPs) are innovative therapies that
encompass gene therapy, somatic cell therapy, and tissue-engineered products. These …

The market authorization procedure for medicinal products for human use is relying on their
demonstrated efficacy, safety, and pharmaceutical quality. This applies to all medicinal …

In recent years, across the European Union (EU), there has been a trend toward
consolidating national-level bodies to a single supranational or pan-national authority. The …

The developers of advanced therapy medicinal products (ATMPs) such as gene and cell
therapies face specific challenges due to the inherent complexity of these products …

Advanced therapy medicinal products (ATMPs), defined as gene therapy medicinal products
(GTMPs), somatic cell therapy medicinal products, and tissue-engineered products (TEPs) …