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Saudi Food & Drug Authority Allows the Import and Use of AstraZeneca Covid19 Vaccine


On February 18/ 2021, SFDA allowed the use of AstraZeneca COVID-19 vaccine that was devolved by the British company incorporation with Oxford University. SFDA's decision is based on the scientific assessments and evaluation of the submitted documents..

Also, The scientific departments at SFDA have reviewed, assessed, evaluated, and tested the safety, efficacy, and quality of the vaccine based on the submitted scientific data which showed the product’s quality and stability.  However, SFDA will test and take samples from each received shipment to ensure their quality and safety before use. Also, SFDA have evaluated the manufacturing phases and facility’s obligation to the international pharmaceutical industry standards in Good Manufacturing practices (GMP). In addition, SFDA did hold meetings with specialized local and global scientists and experts to take their evaluations. Also, SFDA met with the manufacturer company and its representatives to answer SFDA inquiries.

Furthermore, SFDA created a new regulatory guideline to register COVID-19 vaccines which allow the company to submit portions of the regulatory application to the SFDA as they are completed. This guideline was established because the current status of the clinical trial of Covid-19 vaccines are active, and this guideline will accelerate the approval process..

Therefore, the health institutions in the Kingdom of Saudi Arabia will start to use the AstraZeneca vaccine in accordance with the required standards..

The Authority