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EMA defines that a gene therapy medicinal product is a biological medicinal product which fulfills the following two characteristics: (a) it contains an active substance which contains or consists of a recombinant nucleic acid used in or administered to human beings with a view to regulating, repairing, replacing, adding or deleting a genetic sequence; (b) its therapeutic, prophylactic or diagnostic effect relates directly to the recombinant nucleic acid sequence it contains, or to the product of genetic expression of this sequence.
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Gene therapy medicinal products shall include vaccines against infectious diseases.
During gene editing by CRISPR/Cas9, the genes encoding the Cas9 protein and sgRNA are introduced into a cell where a targeted genomic change is planned. The sgRNA has a region complementary to the chosen genomic target sequence (purple); this region can be engineered to include any desired sequence. A complex consisting of the CRISPR sgRNA and the Cas9 protein forms within the cell & binds to the chosen target site in the DNA.
In April 2016 Chinese scientists were reported to have made a second unsuccessful attempt to alter the DNA of non-viable human embryos using CRISPR - this time to alter the CCR9 gene to make the embryo HIV resistant.
Heritable modifications could have unintended and far-reaching consequences for human evolution, genetically (e.g. gene/environment interactions) and culturally (e.g. social Darwinism). Altering of gametocytes and embryos to generate inheritable changes in humans was defined to be responsible.
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