Australia – TGA one of only five non-European regulators invited to participate on European...
Australia, through the TGA, is one of only five non-European Union regulators formally invited to participate by the European Medicines Agency (EMA) on the...
India – Dr Reddy’s to seek approval for Sputnik V jab by March
Dr Reddy’s Laboratories expects to complete phase-3 clinical trials of Russia’s Sputnik V Covid-19 vaccine in India by February-end and seek emergency authorisation for...
Australia – COVID-19 vaccine: Pfizer Australia – COMIRNATY BNT162b2 (mRNA)
The Therapeutic Goods Administration (TGA) has granted provisional approval to Pfizer Australia Pty Ltd for its COVID-19 vaccine, COMIRNATY, making it the first COVID-19 vaccine to...
Australia – COVID-19 vaccine: International collaboration
The Therapeutic Goods Administration (TGA) has strong working relationships with a wide range of international agencies and is part of a network of international...
China – Report: Chinese COVID-19 vaccine safe for children
A clinical trial has found a COVID-19 vaccine in development at a Sinopharm subsidiary to be safe in children aged three to 17 years,...
China – Conditional OK for Sinopharm’s COVID-19 vaccine
The vaccine has been granted a conditional marketing approval, after 60,000 volunteers took part in phase 3 clinical trials across China, UAE and Bahrain.
Last...
India – AstraZeneca vaccine may be approved in India next week
India is likely to approve Oxford/AstraZeneca’s coronavirus vaccine for emergency use by next week after its local manufacturer submitted additional data sought by authorities,...
India – India seeks more data on AstraZeneca COVID vaccine
India’s Subject Expert Committee (SEC) has asked to see additional data on AstraZeneca’s COVID-19 vaccine before deciding whether to grant emergency use authorization (EUA)....
Australia – Over-the-counter access to low dose cannabidiol
Today the Therapeutic Goods Administration (TGA) announced a final decision to down-schedule certain low dose cannabidiol (CBD) preparations from Schedule 4 (Prescription Medicine) to Schedule 3...
International – Asia-Pacific Roundup
Australia's Therapeutic Goods Administration (TGA) and its international collaborators in the Access Consortium have posted their approach to the regulatory evidence requirements for COVID-19...
