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