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(2009; 20 pages)
These regulations prescribe good clinical practice requirements for the conduct of clinical trials, including multi-centre trials, on participants involving medicinal products to ensure that the rights, safety and well-being of trial participants are protected and that the results of the clinical trials are credible.
These regulations shall also apply to clinical trials involving medicinal products for gene therapy and somatic cell therapy, including xenogenic cell therapy or medicinal products containing genetically modified organisms.
All clinical trials, including bioavailability and bioequivalence studies, shall be designed, conducted and reported in accordance with these regulations...