text Clinical medical research regulation lawProvided that “a committee called the “Institutional Committee for the Review of Medical Research Ethics” shall be formed within each research body, by a decision of the competent authority in this body, and it is required that this committee be registered with the Supreme Council..
This committee specializes in the following:
–Caring for the rights, safety and health of the respondents .
–Review the research plans (protocols) submitted to it and ensure that they complete all necessary papers, approvals and documents in this regard, according to each case. .
– Issuing a decision approving a procedure medical research Or renew it, specifying its duration not to exceed one year, and following it up until its termination or expiration .
– Monitoring the principal investigator and research sponsor, if any, to ensure that the medical research is properly implemented and that standards of good medical practice are applied .
Provided that the Institutional Committee is committed to notifying the Supreme Council of all the research submitted to it, provided that the notification includes the medical research protocol and all documents and data related to it, as well as all the procedures taken by the committee in this regard. .
All of this is in the manner indicated by the executive regulations of this law .
Second – the Egyptian Medicines Authority
The Egyptian Medicines Authority, in addition to its specializations stipulated in Law No. 151 of 2019, exercises the following specializations: :
–Evaluation of preclinical and clinical research outcomes .
–Scientific review of a pharmaceutical or biological product, before starting clinical medical research .
–Evaluation of the research plan and the amendments to it, and reviewing the documents related to the medical research product, with the aim of ensuring that good medical practice is achieved for manufacturing, handling and preservation. .
–Inspection of the research bodies in which clinical medical research is conducted and related bodies, in order to verify good medical practice. .
And he 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 referred to, and a decision is issued to determine the categories of this fee by the Prime Minister. .
The executive regulations of this law specify the procedures that ensure that the Egyptian Medicines Authority exercises these specializations, and coordinates between them and each of the specialized institutional committees and the Supreme Council in this regard.
