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China COVID-19 vaccine obtained EU GMP certification
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China COVID-19 vaccine obtained EU GMP certification. On April 1, the Hungarian National Drug Approval and Regulatory Agency officially issued the EU GMP certificate for the COVID-19 inactivated vaccine to the Beijing Institute of Biological Products of SINOPHARM Group.
This is the first vaccine product in China’s history that has been approved for use in the European Union and has been GMP certified. It is a new step for China’s COVID-19 vaccine to become a global public product.
From January 13th to 15th, the Hungarian National Institute of Pharmacy and Nutrition conducted a related GMP audit on the Beijing Institute of Biological Products of SINOPHARM Group. After strict audits and comprehensive judgments, the Hungarian National Institute of Pharmacy and Nutrition believes that the COVID-19 inactivated vaccine produced by the Beijing Institute of Biological Products of SINOPHARM Group meets EU standards and allows emergency use.
On March 3, the Beijing Institute of Biological Products of SINOPHARM Group submitted relevant follow-up reports to the Hungarian Drug Administration. On April 1, in accordance with EU regulatory standards and rules, the Hungarian National Drug Approval and Regulatory Agency formally issued the EU general GMP certificate for the COVID-19 inactivated vaccine to the Beijing Institute of Biological Products of SINOPHARM Group.
On February 16, the first batch of SINOPHARM’s China Biotech Covid-19 vaccine arrived in Budapest, the capital of Hungary. On February 24, Hungary officially became the first EU country to use the Chinese vaccine as Hungary began to vaccinate the SINOPHARM China Biotech Covid-19 vaccine.
▲On February 24, in Varošlöd, Hungary, a family doctor demonstrated the COVID-19 vaccine produced by SINOPHARM China Biotech. Xinhua News Agency
On February 26, Hungarian President Adair received the first dose of SINOPHARM’s China Bio-COVID-19 vaccine. Adair appealed to the public to trust the doctors and the national medical system, and urged the public to register and receive the COVID-19 vaccine approved by the national drug regulatory agency as soon as possible.
On the third day after the president’s vaccination, on February 28, Hungarian Prime Minister Orban announced through social media that he had also received the SINOPHARM China Bio-COVID-19 vaccine in Budapest on the same day.
The two COVID-19 vaccines of SINOPHARM Beijing Institute of Biological Products and Wuhan Institute of Biological Products have been approved for conditional listing in China on December 30, 2020 and February 25, 2021 respectively, and will be released on December 9, 2020.
On December 13, 2021, February 5, and February 25, it was approved for registration and listing in the UAE, Bahrain, Bolivia, and Seychelles.
The global supply and vaccination of SINOPHARM’s China Biotech Covid-19 vaccine have both exceeded 100 million doses, and it has been put into use in 54 countries and regions around the world.
The technical safety of the vaccine, protection effectiveness, population universality, production capacity, and storage The convenience of transportation has been highly recognized by the international community.
(source:internet, reference only)