Hong Kong Proposes Overhaul of Guidance on Medical Device Responsible Persons

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...
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...
Hong Kong Proposes Overhaul of Guidance on Medical Device Responsible Persons

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 Pushes Ahead With Paracetamol Reclassification Despite Objections

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...
India Advances Plan to Create Mobile Drug Testing Laboratories

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...
TGA Overhauls Guidance on Risk Management Plans for Medicines and Biologicals

Australia – Updated GMP licence application e-forms

The revised fees and charges model for domestic medicine manufacturers commenced on 1 July 2018. To fully support these changes the TGA needed to update our...
TGA Overhauls Guidance on Risk Management Plans for Medicines and Biologicals

Australia – Australian manufacturing licences and overseas GMP certification

This step-by-step guide is for: Australian manufacturers of therapeutic goods (medicines, active pharmaceutical ingredients (APIs) and biologicals, human blood and blood components and haematopoietic...
Generic breast cancer drug coming to India

India – Generic breast cancer drug coming to India

Pune-based Emcure Pharma on Wednesday said it is launching the generic version of Eisai Pharma’s breast cancer medicine Eribulin, which will be 40% cheaper...
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...
Chinese scientists develop nanogenerator for cancer drug delivery system

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...

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