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The European Medicines Agency (EMA) operates as a decentralised scientific agency (as opposed to a regulatory authority) of the European Union (EU) and its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. [8]
An Emergency Use Authorization (EUA) in the United States is an authorization granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Acts of Congress, including by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), as codified by 21 U.S.C. § 360bbb-3, to allow the use of a ...
As early as March 2020, the World Health Organization (WHO), [2] European Medicines Agency (EMA), [3] US Food and Drug Administration (FDA), [4] and the Chinese government and drug manufacturers [5] [6] were coordinating with academic and industry researchers to speed development of vaccines, antiviral drugs, and post-infection therapies.
National regulatory authorities have granted full or emergency use authorizations for 40 COVID-19 vaccines.. Ten vaccines have been approved for emergency or full use by at least one stringent regulatory authority recognized by the World Health Organization (WHO): Pfizer–BioNTech, Oxford–AstraZeneca, Sinopharm BIBP, Moderna, Janssen, CoronaVac, Covaxin, Novavax, Convidecia, and Sanofi ...
Part of a series on the COVID-19 pandemic Scientifically accurate atomic model of the external structure of SARS-CoV-2. Each "ball" is an atom. COVID-19 (disease) SARS-CoV-2 (virus) Cases Deaths Timeline 2019 2020 January responses February responses March responses April responses May responses June responses July responses August responses September responses October responses November ...
In February 2021, the FDA issued an emergency use authorization (EUA) for bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 in people twelve years of age or older weighing at least 40 kilograms (88 lb) who test positive for SARS‑CoV‑2 and who are at high risk for progressing to severe COVID-19.
In most countries, a marketing authorisation is valid for a period of 5 years. After this period, one should apply for renewal of the marketing authorisation, usually by providing minimal data proving that quality, efficacy and safety characteristics are maintained and the risk-benefit ratio of the medicinal product is still favourable.
The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (SI 2020/1125) is a statutory instrument (SI) that was laid before Parliament on 16 October 2020 to make provision for the strengthening of existing regulations that allow for the temporary authorisation of the supply of unlicensed medicines, including vaccines, in response to certain public health threats, and for ...