China was the first country in the world that has approved commercial gene therapy products. The first product was called Gendicine. In the western world the first approved gene therapy product was Glybera in 2012. Below is a summary of gene therapy products that are world wide on the market. Please note that the list is not exhaustive.
In Europe, gene therapy products have to be approved by the European Medicines Agency (EMA) which is the European agency for the evaluation of medicinal products, including gene therapy medicinal products. Gene therapy products are regarded as dvanced therapy medicinal products (ATMPs). In the end, the gene therapy products needs to be approved by the European Commission.
- In the US by the FDA
- In Europe by the EMA en EC