Glossário de termos

Procedure to reduce the time of assessment of the marketing authorisation application (from 210 to 150 days) for medicines targeting an unmet medical need.

Adeno-associated viruses (AAV)s are a group of non-disease-causing viruses. The group consists of nine different AAV subgroups, or serotypes, that can enter into different tissue types. AAVs genome is small, and composed of single-stranded DNA. In gene therapy, scientists can modify AAVs or the AAV genome to carry a helpful theraputic gene to patient cells. The modified AAVs carrying the helpful gene are known as recombinant AAV (rAAV) vectors.

Adenoviruses are a type of disease-causing viruses. They carry their genetic material in form of DNA (DNA viruses). Typical illnesses caused by adenovirus include respiratory infections, such as the common cold, and pink eye. In medicine, modified versions of adenoviruses are used to prevent or treat diseases. Some adenoviruses are modified to lose their ability to multiply; these are used in vaccines and in gene therapy as carrier systems (called adenovirus vectors). In cancer treatment, adenoviruses have been modified so that they can only replicate in cancer cells. These modified viruses are used to as a way to target and destroy cancer cells (oncolytic virus therapy). 

Adult, or somatic, stem cells are multipotent or tissue-specific stem cells found in various tissues and organs throughout the body. Unlike embryonic stem cells, they are more limited in their differentiation potential and typically give rise to the cell types associated with their specific tissue or organ. For example, hematopoietic stem cells give rise to the cells of the blood system, and neural stem cells give rise to cells of the nervous system.

An Advanced Therapy Investigational Medicinal Product (ATIMP) is a Advanced Therapy Medicinal Product (ATMP) being tested in a clinical trial. 

An Advanced Therapy Medicinal Product (ATMP) is a medicine based on animal or human gene, cells or tissue. 

Any form of promotion  to persuade someone to prescribe, supply, sell or consume a medicine. It can be done through information, gifts or free samples of a product.

Antibodies, also known as immunoglobulins (Ig), are proteins produced by the immune system in response to the presence of foreign substances called antigens. These antigens can be anything from viruses and bacteria to toxins and other foreign substances. Antibodies are highly specific in their shape. They recognise and bind to particular antigens, marking them for destruction by other components of the immune system or neutralising their harmful effects directly. Antibodies play a crucial role in defending the body against infections and diseases. They come in various classes (IgG, IgM, IgA, IgE, and IgD), each with specific functions and roles in the immune response. In addition to their role in immunity, antibodies are also used in various diagnostic and therapeutic applications, such as in ELISA (enzyme-linked immunosorbent assay) tests, Western blotting, and immunotherapy for treating diseases like cancer and autoimmune disorders.

Antigens are special 'badges' or a 'red flags' recognised by your immune system. They allow the body's defender cells to recognize what belongs to the body and what is foreign. These red flags are different substances on the surface of invaders, such as viruses and bacteria, or on the surface of the body's infected or diseases cells. They are important for triggering the defense system.