In a pronouncement with implications for companies such as AstraZeneca PLC and Novavax, Inc., the Drugs Controller General of India (DCGI), V G Somani, has said the country’s regulatory body does not plan to permit emergency use authorizations (EUAs) for COVID-19 vaccines before the completion of clinical trials.
No EUA For COVID-19 Vaccines Prior To Trials Completion, Says India
Russia To Conduct Phase III Trials In India
The Indian regulator says it is not considering emergency use authorization for COVID-19 vaccines before completion of clinical trials, a stand validated by AstraZeneca halting trials of its vaccine candidate due to an adverse event in UK. Meanwhile, India has signed up for Phase III trials of Russia’s vaccine candidate
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A new chapter that will be published in the European Pharmacopoeia soon is expected to provide a comprehensive framework for the production and quality control of cell-based preparations. Meanwhile, an existing chapter has been revised to facilitate the implementation of rapid microbiological testing methods.