The Ministry of Health ("MoH") is the governmental body in charge of regulating all issues related to the pharmaceutical sector. There are three main authorities affiliated to MoH which are mainly responsible for the pharmaceutical sector:
The Central Administration of Pharmaceutical Affairs ("CAPA") is the regulatory body responsible for registering pharmaceutical products, issuing licenses for the establishment of pharmaceutical entities, and licensing the importation and exportation of pharmaceutical products. CAPA consists of four main departments, licensing, registration, inspection, importation and exportation. CAPA is responsible also for price regulation, as it is the final decision making body for setting the mandatory public price of drugs. In addition, CAPA evaluates clinical trials and post marketing studies of pharmaceutical drugs.
The National Organization for Drug Control and Research ("NODCAR") is a public organization affiliated to MoH. It works as a quality control authority responsible for ensuring the quality, safety, and effectiveness of pharmaceutical products, medicines, cosmetics and insecticides. Samples of new products and products under registration are analyzed in the NODCAR laboratories to assess their compliance with the required standards and ensure their safety and effectiveness. No pharmaceutical product can be registered, marketed, advertised, distributed, imported or imported unless it obtains the necessary compliance certificate from NODCAR.
All biological products like vaccines and serums are monitored, inspected, and released by the National Organization for Research and Control of Biologicals ("NORCB"). NORCB is a public organization affiliated to MoH that was established in 1995. Its main function is to ensure the quality, safety and efficiency of all imported, exported and domestic biological products whether for human being use or for veterinary consumption.
A long waited draft law for the establishment of a unified authority under the name of Egyptian Drug Authority ("EDA"), to be responsible for all drug related matter, is currently debated at the Egyptian House of Representative. Under the draft law, EDA shall be an independent authority reporting directly to the Prime Minister. Upon its establishment, EDA will supervise CAPA, NODCAR and NORCB.
March 07, 2017
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