Written by Hind Adel Monday, July 10, 2023 01:00 AM
Law No. 214 of 2020 regarding the organization of clinical medical research specified the cases in which it is permitted to conduct medical research on humans, as Article 3 of the law stipulates that the conduct of medical research may not be limited to a specific group of people or to groups deserving additional protection except If the research is necessary, and is related to diseases of their own, and with the availability of scientific and ethical justifications for their use, and provided that informed consent is obtained from each of them. In the event of the death of one or both parents or the legal representative, all in accordance with the controls and procedures specified by the executive regulations of this law.
And Article 4 of the law stated that before starting any medical research, there must be a protocol that was reviewed and approved by the relevant institutional committee, provided that its approval is final in matters other than the clinical medical research referred to in the following paragraph.
The approval of the Egyptian Medicines Authority, and the approval and approval of the Supreme Council is required in the case of clinical medical research that includes the use of new or biological drug compounds, new indications, forms, supplies, or medical devices that have not been used in the human body before, and have not obtained the accreditation of the international bodies that you specify. The executive regulations of this law, provided that they are tested in reference countries at the same time.
2023-07-09 22:00:00
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