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...
Chinese NMPA publishes UDI system rules for medical device registrants

China – China approves 17 anti-cancer drugs for medical insurance coverage

China has approved 17 anti-cancer drugs for inclusion in its national health insurance system, the government said on Wednesday, part of its efforts to...
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...
La Chine vend un médicament contre le coronavirus

China – China Creates Guidance to Fast Track Important Drugs Approved Overseas

China National Drug Agency (CNDA) has released guidance aimed at manufacturers of drugs it wants to make available in the country. The guide builds...
La Chine vend un médicament contre le coronavirus

China – Dialogue with Chinese authorities on medicine regulation

The Deputy Commissioner of the Chinese National Medical Product Administration (NMPA), Dr Chen Shifei, visited EMA on 25 October together with a delegation.  The visit took...
Stem cell-based Parkinson's therapy tested in Japan

Japan – Stem cell-based Parkinson’s therapy tested in Japan

Japanese researchers said on Friday (Nov 9) they have transplanted stem cells into the brain of a patient in the first stage of an...
Review of Medicines and Medical Devices Regulation (MMDR).

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...
La Chine vend un médicament contre le coronavirus

China – China publishes 38 punishments for IP fraud, theft

China's National Development and Reform Commission published a list of 38 punishments, to be implemented by multiple government institutions including China’s National Medical Products Administration (NMPA),...
New Zealand Seeks Feedback on Safety-Focused Changes to Paracetamol Labels

New Zealand – New Zealand Pushes Ahead With Paracetamol Reclassification Despite Objections

Regulators in New Zealand have reaffirmed their intention to reclassify modified-release paracetamol as a restricted medicine. Officials proposed strengthening the restrictions on the medicine...
Update: Expanded scope of medical device regulations, plus new expedited registration route

India – India Advances Plan to Create Mobile Drug Testing Laboratories

ndia’s Drugs Consultative Committee (DCC) has backed plans to create mobile laboratories to test drugs around the country. The plans call for one mobile...

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