TGA suspends overseas GMP inspections and QMS audits until further notice

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...
CORONAVIRUS : India halts exports of about 2 dozen APIs, drugs

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...
Australian regulatory action on breast implants and breast tissue expanders

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...
TGA Creates Advertising Guidance for Providers of Cell and Tissue Products

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...
CORONAVIRUS : India halts exports of about 2 dozen APIs, drugs

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,...
CORONAVIRUS : India halts exports of about 2 dozen APIs, drugs

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)....
TGA Creates Advertising Guidance for Providers of Cell and Tissue Products

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...

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