Glossary

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  • Centralised procedure
    The centralised procedure is a process for obtaining marketing authorisation for a medicine in the EU. The European Medicines Agency (EMA) oversees the centralised authorisation procedure for human and veterinary medicines. This procedure results in a single marketing authorisation, granted by(...)
  • Chemotherapy
    Chemotherapy is a type of cancer treatment that uses medicines to destroy cancer cells. Chemotherapy is used along with surgery, radiation therapy, or biological therapy. It works by stopping or slowing the rapidly growing cancer cells. However, chemotherapy can also harm healthy cells that(...)
  • Chronic Condition
    A chronic condition is a long-lasting disease that can be controlled but not cured. The term chronic is usually applied when the course of the disease lasts for more than three months.Common chronic diseases include asthma, chronic obstructive pulmonary disease (COPD), cancer, and diabetes. In(...)
  • Class effect
    Class effect refers to the similar outcomes, therapeutic effects and similar adverse effects of two or more medicines. All products within a class are assumed to be closely related in three concepts: a similar chemical structure, mechanism of action, and pharmacological effects.
  • Classification of a medicinal product
    In the EU there are two classifications of medicinal products for human use: medicinal products subject to medical prescription medicinal products not subject to medical prescriptionFurther subcategories may exist on a national level.
  • Clinical development
    Clinical development is one step in the process of bringing new medicines or treatments to the market. Based on non-clinical research (microorganisms/animals), it refers to clinical trials, which are done in people. They follow different phases designated as Phase I, II, III (and IV after(...)
  • Clinical effectiveness
    As a component of a dossier submitted for HTA assessment, clinical effectiveness is a measure of how well a particular treatment works in the practice of medicine. It depends on the application of the best knowledge derived from research, clinical experience, and patient preferences.
  • Clinical efficacy
    In medicine, clinical efficacy indicates a positive therapeutic effect. If efficacy is established, an intervention is likely to be at least as good as other available interventions to which it will have been compared. When talking in terms of efficacy versus effectiveness, efficacy measures(...)
  • Clinical pharmacology
    In relation to clinical development, pharmacology deals with the effects of compounds (medicines in development) in healthy volunteers and in patients. It usually includes pharmacodynamics and pharmacokinetics. In the evaluation process the action and adverse effects of compounds can be(...)
  • Clinical phase
    The clinical phase of medicines development is the one involving humans, and is different from the ‘non-clinical’ or ‘pre-clinical phase’ in which studies are performed in labs or in animals (such as for pharmacology/toxicology analysis). Clinical studies are conducted in four steps, called(...)
  • CP
    The centralised procedure is a process for obtaining marketing authorisation for a medicine in the EU. The European Medicines Agency (EMA) oversees the centralised authorisation procedure for human and veterinary medicines. This procedure results in a single marketing authorisation, granted by(...)

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