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...
New pharmaceutical company launches in Asia

Asia – New pharmaceutical company launches in Asia

Roivant Sciences has partnered with one of its 15 spinout companies or “vants” to launch the 16th—a biopharma that immediately inked a potentially $1...

China – Chinese company approved for inhaled COVID-19 vaccine trial

China’s CanSino Biologics Inc (CanSinoBIO) said on Tuesday it won approval for a clinical trial in the country to develop a COVID-19 vaccine for...
Chinese NMPA publishes UDI system rules for medical device registrants

China – How trade war with China could hit US pharmaceutical makers

The United States’ heavy reliance on China for prescription drugs is becoming a national security concern. The concern is that China could weaponize its...
Australian regulatory action on breast implants and breast tissue expanders

Australia – Standard for serialisation and data matrix codes on medicines

This guidance is for sponsors and manufacturers supplying medicines in Australia that are serialised or have data matrix codes. It describes the requirements in...
Indian drugmaker receives warning letter from FDA

India – Indian drugmakers form partnerships as they enter the Chinese market

Indian drug makers Sun Pharmaceutical Industriesand Cipla are entering China through local partnerships, as they seek new markets to sell their generic drugs amid stifling competition in...

Australia – Medicine packaging definitions for sponsors

Packaging terms are important to know to ensure sponsors and manufacturers are following the rules when labelling their medicines. Therapeutic goods legislation, GS1 General...
TGA suspends overseas GMP inspections and QMS audits until further notice

Australia – Microbiological quality of medicinal cannabis products

This guidance will assist sponsors and manufacturers of medicinal cannabis products to comply with Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018, referred to...
CORONAVIRUS : India halts exports of about 2 dozen APIs, drugs

India – Pharmaceutical supply disruptions predicted in India

The pharmaceutical industry in Tamil Nadu foresees the months ahead in 2021 will be critical for the production and supply of pharmaceuticals because the...
Médicaments : une évaluation rigoureuse et scientifique par la HAS

India – Intas to provide 2 million hydroxychloroquine tablets for WHO study on COVID-19

Intas Pharmaceuticals Ltd. has said it will provide up to two million tablets of hydroxychloroquine to World Health Organisation-endorsed study into the prevention of...

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