Friday, 22 February 2019

The experimentation and the development of drugs has taken a great relevance in Europe, also thanks to the creation of the European Medicines Agency (EMA) that, among others, has the objective of ensuring that clinical trials in Europe are conducted base on principles of quality, ethics and high level science.

The field is rapidly evolving, particularly within the legal and regulatory framework and gained new development with the recent approval of the Regulation for "advanced therapies", assimilating advanced therapies (gene, cell and tissue) to "pharmaceutical products" where precise standards of quality in all stages of research and clinical use are applied.

These rules are entwined with what already happens in other field of interest, such as the development of biological drugs (first of all the cancer drugs with monoclonal antibodies, etc.), "orphans" and paediatric drugs to which the European legislation has devoted two special regulations.