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An important decision was made by the Ministry of Health while waiting for the vaccine from China, and the provision of ‘Emergency Use Approval’ for vaccines was added to the ‘Human Medicinal Products Licensing Regulation’.
According to the decision published in the Official Gazette, the emergency use of vaccines will be approved for vaccines, although complete data on efficacy, safety and quality cannot be provided in cases considered by the World Health Organization (WHO) or the Ministry of Health in the field of infectious diseases.
“PROCEDURE TO APPLY FOR ALL VACCINES”
Health Minister Fahrettin Koca made a statement about the regulation on his social media account. In the statement, it was indicated that the emergency use approval is used worldwide, especially in the United States and EU countries, and is the procedure to apply for all vaccines, mainly domestic vaccines.
Noting that with the amendment of the regulation, a regulation was made especially regarding the emergency use of vaccines, Minister Koca stated:
* Immediate Use 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 such as Covid-19.
* With the amendment in question, a deficiency was corrected and this practice, which has been used around the world for a long time, is included in our legislation.
“THAT ALSO PRESENTS THE SAME PROCEDURE IN CASE OF NEED”
In stating that Emergency Use Approval is a method that has long been used around the world, especially in the US and EU countries, Koca used the following statements:
* 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.
* Turkey continues to work with our R&D on the 16 different indigenous vaccines. The phase 1 clinical trial of an inactivated vaccine has now been completed and phase 2 studies are in preparation.
* 5 separate vaccines developed simultaneously with different technologies have reached Phase 1. Another purpose of the legislative regulation is to offer our national vaccines, which are completed, to the use of our citizens as soon as possible after the safety tests.
“IT WILL BE SUBJECT TO THE SAME CONDITIONS FOR ALL VACCINES”
“The emergency use approval does not mean a license. Saying that it is only a temporary license whose duration is given until the necessary data for the vaccine license is provided, Koca made the following words:
* It is a procedure to protect public health and prevent delays. It is essential that the product is licensed at the end of the given period.
* The Emergency Use Approval will be granted for all vaccines under the same conditions, regardless of whether they are imported from abroad or produced domestically.
* After demonstrating the safety and effectiveness of the vaccine in a scientific framework, the data obtained will be evaluated according to international standards considering the benefit-risk balance.
* The required technical examination and test results will be given to Turkey as an accredited institution in the authorization of emergency use of international pharmaceutical institutions and medical devices.
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