Article 9 of the Law Regulating Clinical Medical Research stipulates that the Egyptian Medicines Authority, in addition to its powers stipulated in Law No. 151 of 2019, shall be competent to exercise the following powers:
1- Evaluating the results of pre-clinical and clinical medical research.
2- Scientific review of the pharmaceutical or biological preparation, before starting to conduct clinical medical research.
3- Evaluating the research plan and the amendments to it, and reviewing the documents related to the product under medical research with the aim of ensuring that good medical practice for manufacturing, handling and preservation is achieved.
4- Inspecting the research bodies where clinical medical research is conducted and the relevant bodies, for the purpose of verifying good medical practice.
The Egyptian Medicine Authority receives service fees for its activities referred to in the previous items, not exceeding the maximum fees mentioned in the table attached to Law No. 151 of 2019 referred to, and the categories of this fees shall be determined by a decision from the Prime Minister.
The executive regulations of this law specify the procedures that ensure that the Egyptian Medicines Authority exercises these powers, and coordinates between them and each of the competent institutional committees and the Supreme Council in this regard.
2023-12-19 07:00:00
#powers #Egyptian #Medicines #Authority #regard #clinical #medical #research #law #answers
