Regulatory pathway for foreign vaccines issued
April 15, 2021
CDSCO will widely disseminate these guidelines to the concerned stakeholders
The government, on Thursday, issued regulatory pathway related to Covid-19 vaccines approved for restricted use by US FDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency Use Listing (EUL). The Central Drugs Standards Control Organisation (CDSCO), headed by Drugs Controller General of India or DCGI, has laid out the pathway according to which the former will prepare detailed guidelines specifying regulatory pathway for approval of foreign approved Covid vaccines based on NEGVAC recommendations.
CDSCO will take steps to widely disseminate these guidelines to the concerned stakeholders. Applicants for grant of approval for restricted use in emergency situation may be submitted to CDSCO. Application can be made by the foreign manufacturer through its Indian subsidiary or through its authorised agent in India in case it does not hav
Health Ministry issues regulatory pathways for foreign-produced COVID-19 vaccines ANI | Updated: Apr 15, 2021 14:35 IST
New Delhi [India], April 15 (ANI): The Central Government on Thursday issued the regulatory pathway in India for COVID-19 vaccines approved for restricted use by US FDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency Use Listing (EUL), said the Union Health Ministry.
The Central Drugs Standards Control Organisation (CDSCO) headed by Drugs Controller General of India (DCGI) has explained that it prepare detailed guidelines specifying regulatory pathway for approval of foreign approved Covid vaccines based on NEGVAC recommendations. These guidelines have since been prepared and posted by CDSCO on its website. CDSCO will take steps to widely disseminate these guidelines to the concerned stakeholders, the ministry said.
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Amid record spike in daily coronavirus infections, India s drug regulator will take a decision on applications seeking approval for restricted emergency use of foreign produced vaccineswithin three working days from the date of submission, the government said on Thursday. The CentralDrug Authority, CDSCO, will process applications for registration certificates (registration of overseas manufacturing site and product; in this case COVID vaccine) and import license within three working days from the date of approval of restricted use in emergency situation. The CDSCO issued detailed guidelines specifying regulatory pathway for approval of foreign approved COVID-19 vaccines after thecentral government on Tuesday decided to fast-track emergency approvals for all coronavirus jabs that have been given a similar nod by the WHO or regulators in the United States, Europe, Britain or Japan.
Centre issues regulatory pathways for foreign-produced COVID-19 vaccines aninews.in - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from aninews.in Daily Mail and Mail on Sunday newspapers.