Law No. 214 of 2020, promulgating a law regulating clinical medical research, aims 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, and these researches are required To abide by the provisions of relevant laws, charters and regulations, and to be consistent with generally accepted international standards and ethical principles.
The law, in Article 4, made it approved by the institutional committees for most of the medical research protocols submitted to them, and stressed that before starting any medical research, a protocol must be reviewed and approved by the competent institutional committee, and the law defined that committee as a group of Persons with medical and non-medical specialties, who are responsible for reviewing research plans (protocols) and applying the ethical principles to be followed in this regard..
The law obligated in Article 4 to obtain the approval of the Egyptian Medicines Authority and the approval and approval of the Supreme Council in the case of clinical medical research that includes the use of new or biological medicinal compounds, new indications for use, or forms, supplies or medical devices that have not been used in the human body before. It did not get the approval of the international authorities
In order to increase the interest in supporting medical research, as was indicated in the letter of objection, the fourth paragraph established a specific term; To complete all the procedures required to obtain approval within a period not exceeding 60 days as a maximum, and it stipulated that all procedures must be completed from the date of completing the documents, informing the responsible authorities and responding within sixty days from the date of notification. All of this is in the manner indicated by the provisions of this law and the procedures specified by its executive regulations.
