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The law regulating clinical medical research, ratified by the President of the Republic and published in the Official Gazette, divided the stages of medical research into 4 stages that must be implemented as stipulated in order to complete the medical research.
Article 10 of the law stipulates that clinical medical research must be preceded by pre-clinical medical research that has been scientifically reviewed and approved in writing by the Egyptian Drug Authority. Clinical medical research is divided into four stages, as follows:
The first stage: the first stage of human trials, in which a group of respondents are 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 is from one group to another and after ensuring the safety of the results Medical intervention on the group that precedes it, and this stage aims to ensure the safety of medical intervention. .
The second stage: It is the stage in which clinical medical research is conducted on a larger group of respondents, whose number ranges from two hundred to three hundred respondents who suffer from the disease targeted by clinical medical research, and this stage aims to help in knowing how the medical intervention works. .
As for the third stage: it is the stage in which clinical medical research is conducted on a group of respondents (patients) whose number ranges from hundreds to thousands. This stage aims to know the effectiveness of medical intervention compared to the best available treatments.
The fourth stage: It is known as the post-marketing stage, and it includes continuous safe monitoring of the drug after obtaining the license to circulate. All the aforementioned stages are allowed to take place on condition that the results of each stage are reviewed, and the transition to the next stage is permitted after the approval of the Egyptian Medicines Authority.
As for medical interventions that originate outside the Arab Republic of Egypt, it is permitted to conduct the third and fourth stages after reviewing and approving the results of the first and second stages, which were conducted in the country of origin by the Egyptian Drug Authority and the Supreme Council.
With the exception of medical interventions for regional diseases that are not present in the country of origin of the medical intervention and rare diseases, it is permitted to conduct medical research on any of them within the Arab Republic of Egypt starting from the second stage, and according to what is decided by the Supreme Council
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The situation in Egypt
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Injuries
139,471
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Recovered
112,826
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Mortality
7,687
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