China's NMPA greenlights 4 coronavirus detection products

China – China reduces penalties on unapproved drug imports

China said it would reduce the penalties for the sale and import of unapproved drugs, effectively giving poor and critically ill patients the green...
Indian drugmaker receives warning letter from FDA

India – India to Add EU to List of Regions Covered by Clinical Trial...

India is planning to add the European Union to the list of regions covered by its clinical trial waiver rule. The change will free...
India Seeks Feedback on Mandatory use of QR Codes on API Packaging

India – India Seeks Feedback on Mandatory use of QR Codes on API Packaging

India is planning to require manufacturers to feature quick response (QR) codes on the packaging of locally made and imported active pharmaceutical ingredients (API)....
China's NMPA greenlights 4 coronavirus detection products

China – Novartis plans to submit 50 new drug applications in China by 2023

The Financial Time reports that Novartis (NYSE:NVS) expects to file 50 applications for drug approvals in China by 2023, about evenly split between on-patent and off-patent...
TGA Clears Pharmacies to Advertise Salbutamol Inhalers During Fires

Australia – Advertising therapeutic goods: Natural claims on medicines and medical devices: naturally compelling?

Advertisers of medicines and medical devices sometimes promote on labels and in other advertising that their product is ‘natural’ or contains ‘natural’ ingredients. Variations...
TGA Updates Guidance on the Testing of Biological Medicines

Australia – TGA Updates Guidance on the Testing of Biological Medicines

Australia’s Therapeutic Goods Administration (TGA) has updated its guidance on testing biological medicines. Version 2.0 of the guidance features new details on the use...
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...
TGA Creates Advertising Guidance for Providers of Cell and Tissue Products

Australia – Updates to variations to prescription medicines guidance and e-form

The TGA Business Services online application system for variations to prescription medicines was updated on 10 July 2019. This was the second part of...
India’s CDSCO Publishes List of Drugs Covered by Bioequivalence Study Rules

India – India Proposes Making Marketers Responsible for Drug Product Quality

The Indian health ministry is planning to make marketers responsible for the quality of the medicines they sell. Under the Drugs and Cosmetics Rules, manufacturers...
Chinese NMPA publishes UDI system rules for medical device registrants

China – Health leaders see fast growth in China pharma, biotech

Two hundred million Chinese citizens will be 60 by the year 2020 and, today, one in four cases of cancer occurs in China. Demographic necessities...

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