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Health Minister Fahrettin Koca will be used for the administration of Covid-19 vaccines ‘Emergency use approval’ Regarding the procedure, “The emergency use approval does not mean a license. It is only a temporary license whose duration is given until the necessary data for the registration of the vaccine are provided. said.
The Minister of Health, Fahrettin Koca, in his statement on his Twitter account, published in the Official Gazette. ‘Regulation on the modification of the Regulation of registration of medicines for human use’ He noted that with the amendment, the regulations regarding the approval of the emergency use of the vaccines were made and continued as follows: “Use Immediately Approval is an application that allows citizens to access safe vaccines as soon as possible, developed to prevent the spread and protect public health in pandemics like Covid-19. With the amendment in question, a deficiency was corrected and this practice, which has been used for a long time around the world, is included in our legislation..
The approval given to Covid-19 vaccines, which are currently prominent in the world, is within this scope. The World Health Organization also prescribes the same procedure for various groups of products, including vaccines, when necessary. Our R&D efforts on 16 different indigenous vaccines from Turkey continue. The phase 1 clinical trial of an inactivated vaccine has already been completed and phase 2 studies are in preparation. Our 5 separate vaccines, developed simultaneously with different technologies, have reached the Phase 1 stage. Another purpose of the regulation is to provide our citizens our domestic vaccinations, which are completed, as soon as possible after safety tests..
Emergency use approval is a process created to protect public health and prevent delays. It is essential that the product is licensed at the end of the given period. Emergency use approval will be granted for all vaccines, regardless of whether they are imported from abroad or produced domestically. After demonstrating the safety and effectiveness of the vaccine in a scientific framework, compliance with the data obtained with international standards will be evaluated considering the benefit-risk balance. Technical studies and tests have shown that an emergency use authorization will be granted from an international medical device and pharmaceutical institution in Turkey from an accredited institution. “
