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Top News In உலகம் ஆரோக்கியம் ஆர்கநைஸேஶந் அவசரம் பயன்பாடு பட்டியல் Today - Breaking & Trending Today

Drug regulator says no need for bridging trials on foreign approved vaccines before India roll out

Drug regulator says no need for bridging trials on foreign approved vaccines before India roll out
DCGI modifies earlier order on emergency approval of well-established vaccines, waives several requirements, but retains assessment of first 100 beneficiaries before proper roll out.
Himani Chandna 2 June, 2021 10:32 am IST
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New Delhi: The country’s apex drug regulator Tuesday announced it was waiving off the requirement of conducting post-approval bridging trials in India for well-established vaccines as well as testing each batch of vaccines at the Central Drugs Laboratory (CDL) in Kasauli.
The Drugs Controller General of India (DCGI)’s decision to make these exemptions for all “well established” vaccines was made from the standpoint “that millions of individuals have already been vaccinated”. ....

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WHO Authorizes Sinovac's CoronaVac For Emergency Use

WHO Authorizes Sinovac s CoronaVac For Emergency Use
BEIJING (dpa-AFX) - Chinese biopharmaceutical company Sinovac Biotech Ltd. (SVA) announced that CoronaVac, an innovative, inactivated coronavirus vaccine developed by its subsidiary Sinovac Life Sciences Co., Ltd., was approved for emergency use under the World Health Organization Emergency Use Listing (EUL) procedure.
Prior to this, the Strategic Advisory Group of Experts on Immunization had recommended CoronaVac for use in adults 18 years and older in a two-dose schedule with an interval of 2 to 4 weeks.
The WHO EUL procedure is a technical review process to assess and review unlicensed vaccines and other products to expedite their availability to people affected by public health emergencies. ....

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Marks: Yankees' breakthrough Covid cases 'not...shocking'

Marks: Yankees' breakthrough Covid cases 'not...shocking'
politico.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from politico.com Daily Mail and Mail on Sunday newspapers.

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What Is Happening to India's COVID-19 Vaccine Program? - Carnegie India - Carnegie Endowment for International Peace

What Is Happening to India's COVID-19 Vaccine Program? - Carnegie India - Carnegie Endowment for International Peace
carnegieindia.org - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from carnegieindia.org Daily Mail and Mail on Sunday newspapers.

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EMA begins rolling reviews for a COVID-19 therapeutic and a vaccine

EMA begins rolling reviews for a COVID-19 therapeutic and a vaccine
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The European Medicines Agency (EMA) has initiated a rolling reviews of Vero Cell, an inactivated COVID-19 vaccine, and sotrovimab, a monoclonal antibody.
The European Medicines Agency (EMA) uses rolling reviews to speed up the assessment of a promising medicine during a public health emergency, such as the COVID-19 pandemic. Under the typical application process for marketing authorisation, all data on a medicine or vaccine’s effectiveness, safety and quality, as well as all required documents must be ready at the start of the evaluation. In the case of a rolling review, EMA’s Committee for Medicinal Products for Human Use (CHMP) reviews data as they become available from ongoing studies. Once it decides that sufficient data are available, the company can submit a formal application. This shortens the approval timeframe. ....

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