In most cases, regulatory authorities, such as the EMA (European Medicines Agency), require that bioequivalence studies (which are a key part of the generic drug approval process) be conducted with healthy volunteers. This requirement arises from the need to obtain objective data that is not distorted by external factors.

A clinical trial can only commence after receiving a positive opinion from the ethics committee and obtaining approval from the Ministry of Health, based on the evaluation of the project documentation and the medicinal product in the Central Register of Clinical Trials (CEBK), a unit operating within the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products. The principal investigator and the trial sponsor are obligated to continuously report any adverse events reported by patients to the ethics committee. The committee may decide to suspend the trial if experts deem that the risk-benefit ratio precludes further progression of the project. This provides additional protection for the rights of participants and safety of volunteers. The pharmaceutical company also regularly updates all doctors, CEBK, and ethics committees.