Why are clinical trials conducted?

Clinical trials are the basis for the development of innovative medicine. Each medicinal product, medical device or new technology must successfully pass all phases (I, II and III) of clinical trials in order to apply for registration. An exception to this rule is bioequivalence testing, which is characterized by a single cycle of testing without phase separation, after which it is possible to register a generic drug. Based on the results obtained, the appropriate regulatory authorities URPL in Poland and the European Medicines Agency (EMA) in the European Union decide and issue permits for the registration of the product. Clinical trials are conducted in order to demonstrate the effectiveness and safety of the tested drug.

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