Article 238. Clinical trials of medicines, medical devices and clinical and laboratory tests of medical devices for diagnosis outside a living organism (in vitro) Code on the Health of the People and the Healthcare System of the Republic of Kazakhstan
1. Clinical trials of medicines and medical devices are conducted with the participation of a person as a subject to identify or confirm the clinical and (or) pharmacodynamic effects of the investigated pharmacological or medicinal product and (or) identify adverse reactions and (or) to study the absorption, distribution, biotransformation and elimination of medicines, safety assessment and (or) functional characteristics of medical devices and (or) adverse events of a medical device to establish safety and effectiveness.
Clinical and laboratory tests of medical devices for diagnosis outside a living organism (in vitro) are carried out for analytical characteristics, clinical effectiveness (if applicable) to establish the conformity of a medical device for diagnosis outside a living organism (in vitro).
2. Clinical trials are conducted in accordance with the rules of good clinical practice (GCP) of the Republic of Kazakhstan and (or) the Eurasian Economic Union.
3. Accelerated examination of clinical trials (hereinafter referred to as the accelerated procedure) is carried out for medicines:
1) designed to prevent emergencies;
2) orphan drugs;
3) medicines of advanced therapy produced for individual use using autologous biological materials of the patient or his donor, selected directly for him.
4. The accelerated procedure does not reduce the requirements for the safety, effectiveness and quality of medicines.
5. The applicant provides reasonable evidence of the necessity and possibility of conducting an accelerated examination, confirmed by the authorized body.
6. The procedure for conducting clinical trials of medicines and medical devices, clinical and laboratory tests of medical devices for diagnosis outside a living organism (in vitro) and the requirements for clinical databases are determined by the authorized body.
President
Republic of Kazakhstan
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