Before being put on the market, 18 steps that the drug goes through to register it with the Pharmacy Department

Before being put on the market, 18 steps that the drug goes through to register it with the Pharmacy Department

The Central Administration for Pharmacy Affairs determines a number of procedures for registering the drug, to ensure its effectiveness in treating the disease for which it is manufactured, without affecting the health of those infected with it. In the following report, "Consulto" reviews the procedures for registering local and imported drugs, and the difference between them, according to Dr. Rasha Ziadeh, head of the Central Department of Pharmacy. imported medicine It requires companies that produce the imported drug to submit papers, studies and analyzes for it, to be presented to committees at the Pharmacy Administration, and tests are conducted on it, with the condition of obtaining the approval of the US Food and Drug Administration (FDA). local medicine The drug is presented to committees from the Pharmacy Administration, to ensure its stability, efficacy and safety, as well as a review of the clinical trials conducted on it. Medication registration procedure Submitting the registration papers to the Pharmacy Department. Responding to the acceptance of the registration request within 12 working days. Giving a period of 3 months for the registration applicant to submit all documents related to the drug. Presenting the drug to the technical committee, to monitor it for a period of 15 working days from submitting the required documents. Transferring the drug to be presented to the specialized practical committees, in case the documents are accepted. The technical committee may inspect the drug production line imported abroad. In the event that the technical committee for drug control requests drug documents, the registration applicant must submit them within a maximum of two months. The applicant for registration submits the scientific file, including the clinical trials of the drug, to the scientific committees, with a maximum of one and a half months, to determine whether the drug is approved or not. In the event that the scientific committee approves the drug, the applicant shall be notified to complete the registration procedures. - The registration applicant submits a request to the Names and Cards Department, to approve the name of the preparation, within 5 working days. Submit a request to the Pricing Department to approve the price of the drug within 30 days, and if the price is not approved, the registration applicant must file a grievance within 15 days. The names and cards are reviewed, as well as an evaluation of the quality file of the drug, with a representative of the Egyptian Vigilance Center and the Pricing Department, in preparation for the final registration of the drug. After the issuance of all approvals from the various departments of the Central Administration for Pharmaceutical Affairs, the holder of the registration begins to calculate 6 months for the registration of the drug Approval of importing samples of medicine for analysis. Analysis of the drug by the National Authority for Drug Control and Research within a maximum of 15 working days. The final review of the file is done by the cosmetics work team. - In the case of local medicine, it is allowed to import raw materials and start manufacturing it, and produce only three batches, provided that they are not circulated, and samples of them are sent to the National Authority for Drug Control and Research on Medicines, for analysis. A stability study is conducted on local medicines, and if successful, registration is approved.