Law no. 214 of 2020 aims to enact a law that regulates medical-clinical research, to lay the foundations, standards and controls necessary to conduct medical-clinical research and to protect respondents, regardless of whether this research is preventive, diagnostic, curative. o non-curative, invasive or non-invasive Adheres to the provisions of relevant laws, statutes and regulations, provided they are consistent with international standards and generally accepted ethical principles.
The legislation, as well as the executive regulations of the recently enacted law, govern the relationship between researcher and respondent, the obligations incumbent on the former and the rights of the respondents, as well as the obligations incumbent on the scientific research sponsor, as well as the stages of conducting the research. medical-clinic, as well as the provisions for the use of human samples and the prescriptions of the research authorities following his research.
The executive regulation establishes the stages of conducting clinical medical research, which is authorized to move between each phase of the four phases of medical and clinical research after the Egyptian Medicines Authority has assessed and approved the results of each phase and allows the transition to the next stage.
While the first phase arrives, that of the first human experiments, in which a group of respondents, healthy or sick, is selected and their number varies between twenty and eighty, and they are divided into small groups, provided that the switching 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 varies between the two hundred and three hundred respondents who suffer from the disease targeted by clinical medical research.
The third phase, by law, is the one in which medical-clinical research is conducted on a group of interviewees (patients), whose number varies between hundreds and thousands Post-marketing, which provides for the continuous and safe monitoring of the drug he later received a business license.
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