- Biopharma News
Russia submits Sputnik V emergency use and prequalification application to WHO27 Oct 2020
The Russian Federation has become one of the first countries to apply to the WHO for prequalification of its vaccine, Sputnik V, against the novel coronavirus infection.
The Russian Direct Investment Fund (RDIF), Russia's sovereign wealth fund, has applied to the World Health Organization (WHO) for accelerated registration (Emergency Use Listing, EUL) and prequalification of the world’s first registered vaccine against the coronavirus, Sputnik V (V for vaccine).
The Prequalification of Medicines Programme — a United Nations programme managed by WHO — is the only global medicines quality assurance programme. It assesses the quality, safety and efficacy of medicines.
To make it on to the list of prequalified medicinal products, each one must comply with established requirements and standards of WHO.
In the face of the ongoing pandemic, accelerated vaccine registration under the EUL procedure will make the Russian vaccine available globally in a shorter time frame than usual procedures and will support global efforts to prevent the coronavirus infection.
Successful prequalification will enable Sputnik V to be included in the list of medicines used by international procurement agencies and countries to guide bulk purchasing of medicines.
Sputnik V, which was developed by Gamaleya Research Institute of Epidemiology and Microbiology, was registered by the Russian Ministry of Health on 11 August 2020.
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