Law No. 214 of 2020 aims to issue a law regulating clinical medical research, to lay the foundations, standards and controls necessary for conducting clinical medical research, and to protect respondents, whether this research is preventive, diagnostic, curative or non-curative, invasive or non-intrusive. Adheres to the provisions of relevant laws, charters and regulations, provided that they are consistent with generally accepted international standards and ethical principles.
The legislation, as well as the executive regulations of the recently issued law, regulate the relationship between the researcher and the respondent, the obligations that fall on the first and the rights of the respondents, as well as the obligations that fall on the sponsor of scientific research, as well as the stages of conducting clinical medical research, as well as the provisions for the use of human samples and the requirements of the research authorities that follow. her search.
The executive regulation stipulates the stages of conducting clinical medical research, that it is authorized to move between each stage of the four clinical medical research stages after the Egyptian Medicines Authority evaluates and approves the results of each stage, and allows the transition to the next stage.
While the first stage comes, to be the stage of the first experiments on humans, in which a group of respondents is selected, whether they are healthy or sick, and their number ranges between twenty to eighty respondents, and they are divided into small groups, provided that the transition from one group to another after making sure of The safety of the results of the medical intervention on the group that precedes it, and the second is in which clinical medical research is conducted on a larger group of respondents whose number ranges between two hundred to three hundred respondents who suffer from the disease targeted by the clinical medical research.
The third stage, according to the law, is the stage in which clinical medical research is conducted on a group of respondents (patients), whose number ranges between hundreds and thousands. Post-marketing, which includes the continuous safe monitoring of the drug after it has received a trading license.