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The authority held several meetings to study the data provided by the company, which included meetings with local and international experts and scientists, in addition to meeting with the manufacturer and its representatives to respond to the queries submitted by the authority, and the decision was also taken. opinion of the scientific advisory team on infectious diseases emanating from the Scientific Advisory Committee for Clinical Studies.
According to the system of pharmaceutical and herbal preparations and facilities, the registration committee of pharmaceutical companies and factories and their products held a meeting to study the scientific data and reports, and then to present and discuss the issue in all its technical and scientists, the committee decided to approve the vaccine’s registration and allow its use.
As for when the vaccine will arrive and start to use it, the authority clarified that based on the approval issued on Thursday, the competent health authorities will initiate import procedures in accordance with the standards and requirements for this, and the authority will analyze samples of each incoming shipment of the vaccine before use to ensure its quality, and the Ministry of Health will announce the date. The arrival and initiation of use of the vaccine after import requirements are completed.
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The authority’s approval decision to register the vaccine and allow its use was based on data provided by Pfizer on November 24, 2020, to be the first vaccine approved by Saudi Arabia, and then the Kingdom’s health authorities could import and use the vaccine.
The Saudi Commission stated that the review and evaluation processes of the log files included the evaluation of the efficacy and safety data of the vaccine, which were demonstrated by clinical trials and studies, as well as verifying the quality of the vaccine by review of scientific data that indicates the quality of manufacture and stability of the product, in addition to verifying the manufacturing stages and the commitment of the factory to apply the principles of manufacture. Good drugGMPAccording to international standards in the pharmaceutical industry, according to the Saudi Press Agency, “SPA”.
The authority held several meetings to study the data provided by the company, which included meetings with local and international experts and scientists, in addition to meeting with the manufacturer and its representatives to respond to the queries submitted by the authority, and the decision was also taken. opinion of the scientific advisory team on infectious diseases emanating from the Scientific Advisory Committee for Clinical Studies.
According to the system of pharmaceutical and herbal preparations and facilities, the registration committee of pharmaceutical companies and factories and their products held a meeting to study the scientific data and reports, and then to present and discuss the issue in all its technical and scientists, the committee decided to approve the vaccine’s registration and allow its use.
As for when the vaccine will arrive and begin to use it, the authority clarified that based on the approval issued on Thursday, the competent health authorities will initiate import procedures according to the standards and requirements for this, and the authority will analyze samples of each incoming shipment of the vaccine before use to ensure its quality, and the Ministry of Health will announce the date. The arrival and initiation of use of the vaccine after import requirements are completed.
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