Advanced therapy medicinal products (ATMPs)/cellular therapy and gene therapy (CGT) products are a rapidly growing innovative class of biopharmaceuticals due to their potential to offer therapeutic breakthroughs for many ailments, especially life-threatening cancers and rare serious inherited disorders for which conventional medicine and various other modalities have not been completely effective.
These products are being increasingly researched and are emerging as promising therapies due to their unique ability to address the unmet medical needs, health authorities across the globe are actively encouraging their development. Due to nature, complexity and novelty of these products, industry and regulatory authorities are constantly contributing towards evolving the guidelines and approach to handle these products. Classification of cell and gene products is complex and the respective terminologies also vary in the US and EU.
Learn from this article how these products are categorised and how the regulators are working along with the industry by providing close oversight and scientific advice, wherever applicable, to further accelerate their development.