New Delhi: The requirement to conduct a bridging medical examine of its single-dose Janssen Covid-19 vaccine not exists in India, pharmaceutical firm Johnson & Johnson has stated.
The US-based firm stated it was following the latest announcement by the Drug Controller Basic of India (DCGI) that there was not any requirement for conducting post-approval bridging medical trials for Covid-19 vaccines in India.
The approval from DGCI will not be required for covid vaccines restricted to make use of in case these are already accepted for restricted use by the US Meals and Drug Administration (FDA), European Medicines Company (EMA), UK Medicines and Healthcare merchandise Regulatory Company (MHRA), Prescription drugs and Medical Units Company (PMDA) Japan or listed in WHO Emergency Use Itemizing (EUL).
Johnson & Johnson stated it stays totally targeted on “bringing a protected and efficient Covid-19 vaccine to individuals in India”.
“We’re in ongoing discussions with the Authorities of India and are exploring how greatest to speed up our capacity to ship our Covid-19 vaccine to India,” the pharmaceutical firm added.
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