Law No. 214 of 2020: Clinical Medical Research in Egypt – Stages and Regulations

2023-09-16 04:00:00

Written by Hind Adel Saturday, September 16, 2023 07:00 AM Law No. 214 of 2020 regarding the organization of… Clinical medical research In its Article No. 10, the conditions for conducting clinical research are that it must be preceded by pre-clinical medical research, which has been scientifically reviewed and approved in writing by the Egyptian Medicines Authority.

Clinical medical research is divided into four stages, as follows:

The first stage:

The first stage of experiments on humans, in which a group of subjects are selected, whether healthy or sick, and their number ranges from twenty to eighty subjects, and they are divided into small groups, provided that the transfer from one group to another occurs following ensuring the safety of the results of the medical intervention on the group to which precedes it.

This stage aims to ensure the safety of the medical intervention.

The second phase:

The stage in which clinical medical research is conducted on a larger group of subjects whose number ranges between two to three hundred subjects who suffer from the disease targeted by the clinical medical research.

This stage aims to help in knowing how the medical intervention works, and to complete what was researched in the first stage regarding the safety of the medical intervention in larger groups of patients.

third level:

The stage in which clinical medical research is conducted on a group of subjects (patients) whose number ranges between hundreds and thousands.

This stage aims to determine 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 following it obtains a trading license.

It is permissible to conduct all the aforementioned stages on the condition that the results of each stage are reviewed and the transition to the next stage is permitted following the approval of the Egyptian Medicines Authority.

As for medical interventions that originate outside the Arab Republic of Egypt, the third and fourth stages are permitted following reviewing and approving the results of the first and second stages that were conducted in the country of origin by the Egyptian Medicines Authority and the Supreme Council.

Medical interventions related to regional diseases that do not exist in the country of origin of the medical intervention and rare diseases are excluded from this. Medical research on any of them is allowed to be conducted within the Arab Republic of Egypt starting from the second stage, and according to what is approved by the Supreme Council.

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