Laws and regulations for medicinal products need to be carefully considered throughout the whole development trajectory. This roadmap shows the trajectory of drug development; from …

Medical product classification determinations often focus substantially on whether a product that meets the definition of drug also meets the statutory definition of device.

Advanced therapy medicinal products (ATMPs) comprise a category of innovative and complex biological products, which in most cases require extensive and complicated preclinical and …

Companies can consult the European Medicines Agency (EMA) to determine whether a medicine they are developing is an advanced therapy medicinal product (ATMP). The procedure allows …

Gene therapy product and somatic cell therapy products are explained in detail, including the differences between the two in the subsequent sections.

Feb 1, 2024 · Therapeutic biology encompasses different modalities, and their manufacturing processes may be vastly different. However, there are many similarities that run across the …

Oct 22, 2024 · In recent years advances in biology, biotechnology, and medical research have led to a new category of biologicals – the advanced therapy medicinal products (ATMPs). ATMPs …

ICH is a consensus-driven process that involves technical experts from regulatory authorities and industry parties in detailed technical and science-based harmonization work that results in the...

The pharmaceutical development of a medicinal product encom-passes the medicinal product lifecycle from basic research to market-ing authorization (MA) and postmarketing surveillance.

The European Medicines Agency's scientific guidelines on pharmaceutical development help medicine developers prepare marketing authorisation applications for human medicines.