To obtain permission to conduct clinical trials of a new drug implementer (or a specially authorized person) shall submit an application to the Ministry of Health of Republic of Belarus, where should be attached pre-clinical studies and a plan of clinical research in the form of a protocol containing the scientific justification for the purpose and objectives of the study, a detailed description of all phases of research and evaluation, including results statistics. Only after a comprehensive examination of submissions by experts and a positive assessment by the Commission on drugs Ministry of Health approve study protocol and issue permission to conduct clinical trials of a new drug.

Clinical drug trials should be carried out in accordance with the international code of GCP (Good Clinical Practice) is the ethical and scientific quality standard of planning, conducting and documenting clinical trials on humans, that guarantees the reliability and validity of the results and protect rights and safety of tested.

The entire process of conducting clinical trials of medicinal products is divided into 4 stages (phases), which allows for gradual expansion of research scope.

Currently it is generally accepted that a full assessment of the efficacy and safety of the drug can only be done after a long period of its application in clinical practice. Epidemiological studies help to reduce this period.

Conducting post-marketing studies are compulsory for manufacturers because the results should be submitted to the Ministry of Health at the state drug re-registration that is held every 5 years.