Good Clinical Practice (GCP) describes the ethical and scientific quality standard for designing, conducting and reporting trials that involve the participation of human subjects. The International Conference on Harmonisation standardised (ICH) practice across Europe, Japan and the USA.For CTIMPs, it is a legal requirement that the trial is run to the principles of GCP.
The deliberate introduction of genetic material into human somatic cells for therapeutic, prophylactic or diagnostic purposes. This includes techniques for delivering synthetic or recombinant nucleic acids into humans and also involves (in the UK definition):genetically modified biological vectors (such as viruses or plasmids) genetically modified stem cells oncolytic viruses nucleic acids associated with delivery vehicles naked nucleic acids antisense techniques (for example, gene silencing, gene correction or gene modification) Genetic vaccines DNA or RNA technologies such as RNA interference Xenotransplantation of animal cells (but not solid organs).
Good Manufacturing Practice is that part of quality assurance which ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorisation (MA) or product specification. GMP is concerned with both production and quality control.
Gene Therapy Advisory Committee is the ethics committee for CTIMP's of gene therapies (as defined in Gene Therapy, which includes stem cell therapy trials and trials of tissue engineered medicinal products).