text Clinical Medical Research Regulation ActProvided that “a committee called “Institutional Committee for the Review of Medical Research Ethics” is formed within each research institution, by a decision of the competent authority in this body, and it is necessary that this committee be registered at the Supreme Council..
This committee specializes in the following:
–Take care of the rights, safety and health of the interviewees .
–Review the research plans (protocols) submitted to them and ensure they complete all necessary paperwork, approvals and paperwork, as applicable. .
– Issue of a decision approving a procedure medical research Or renew it, specifying its duration not exceeding one year, and follow it until its termination or expiration .
– Monitor the principal investigator and research sponsor, if any, to ensure medical research is properly implemented and standards of good medical practice are applied .
It being understood that the Institutional Commission undertakes to notify the Supreme Council of all research submitted to it, provided that the communication includes the medical research protocol and all the documents and data relating to it, as well as all the procedures adopted by the Commission in this regard. .
All this as indicated by the executive rules of this law .
Second: the Egyptian Medicines Authority
The Egyptian Medicines Authority, in addition to the specializations established by law n. 151 of 2019, exercises the following specializations: :
–Evaluation of the results of preclinical and clinical research .
–Scientific review of a pharmaceutical or biological product, before starting medical-clinical research .
–Evaluation of the research plan and the changes made to it and review of the documents relating to the medical research product, with the aim of ensuring the achievement of good medical practice for production, handling and conservation. .
–Inspection of research institutions where medical-clinical research is carried out and related institutions, in order to verify good medical practice. .
And collects in favor of the Egyptian Medicines Authority a fee for a service in exchange for its activities referred to in the previous clauses, provided that it does not exceed the maximum fee contained in the table attached to Law no. 151 of 2019 recalled, and a decision is issued to determine the categories of this tax by the Prime Minister. .
The Executive Regulations of this law specify the procedures that ensure that the Egyptian Medicines Authority exercises these endorsements and coordinates with each other and each of the specialized institutional committees and the Supreme Council in this regard.
