Statement from Health Minister Fahrettin Koca on “Approval of Emergency Use”:



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Declaration of ’emergency use’ by Minister Koca

The husband of the ministers, sharing his Twitter account published today in the Official Gazette of Turkey and the Agency for Pharmaceutical Products and Medical Devices of which allows to provide Emergency Use Authorization “Regulation on the Amendment of Licenses of Medicinal Products” gave information about.

The regulation is seen as spreading unsubstantiated information regarding the transfer of the minister’s husband, the regulations in particular make arrangements for all vaccines to be used in domestic vaccine candidates and Turkey emphasized.

Stating that the Emergency Use Approval was developed to prevent the spread of pandemics like Kovid-19 and to protect public health, Koca said that it is an application that allows citizens to access safe vaccines as soon as possible, he said:

“With the change in question, a deficiency has been eliminated and this practice, which has been used for a long time around the world, has been included in our legislation. The approval of emergency use has been used for a long time throughout the world, especially in the United States and the countries of the European Union. The World Health Organization also recommends the same procedure for several groups of products, including vaccines, when necessary. “

Turkey continued throughout the 16 different indigenous vaccine R&D efforts. Notifications Koca, has already said that an inactivated vaccine in Phase 1 and Phase 2 clinical trials works to prepare for the end point.

Noting that 5 different vaccines developed simultaneously with different technologies have reached the Phase 1 stage, Koca conducted the following evaluations:

“Another purpose of the legislative regulation is to provide our citizens with our domestic vaccines, the studies of which have been completed, for the use of our citizens as soon as possible after the safety tests. Emergency Use Approval does not mean ‘license’. It is only a temporary license whose duration is granted until the necessary data for the vaccine license is provided. It is critical that the product is licensed at the end of the given period. Approval for Emergency Use will be granted for all vaccines under the same conditions, regardless of whether they are brought from abroad or of national production. Compliance with international standards will be evaluated taking into account the benefit-risk balance of the data. The necessary technical studies and tests have shown that Turkey will be an institution that has international accreditation for medical devices and approval for emergency use from the pharmaceutical authority. “

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