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

Australia – Australia Looks to Improve Generic Drug Authorization Process

Australia’s Therapeutic Goods Administration (TGA) announced Thursday that it’s considering a range of options to improve the generic medicine registration process. Chief among those options...
Chinese scientists develop nanogenerator for cancer drug delivery system

China – China Charges Vaccine Manufacturer $1.3B for Quality Failings

China has charged Changchun Changsheng Biotechnology RMB 9.1 billion ($1.3 billion) for the quality failings behind the recent vaccine scandal. The penalty is 16...
Takeda gets China's approval for $62 billion Shire purchase

China – Takeda gets China’s approval for $62 billion Shire purchase

Takeda Pharmaceutical Co Ltd said on Friday China approved its purchase of Shire Plc, the latest regulator to clear the $62 billion deal and...
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...
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...
Japanese study underscores efficacy of HCV drug elbasvir/grazoprevir

Japan – Japanese study underscores efficacy of HCV drug elbasvir/grazoprevir

A new review of clinical trial data show the combination therapy elbasvir/grazoprevir (EBR/GR) has high rates of efficacy for patients with genotypes 1a, 1b,...
Home-grown colorectal cancer drug approved in China

China – Home-grown colorectal cancer drug approved in China

The green light from the National Medical Products Administration of China (formerly the China Food and Drug Administration) is for use of the oral...
TGA Overhauls Guidance on Risk Management Plans for Medicines and Biologicals

Australia – TGA Plans GCP Inspection Program to Ensure Global Recognition of Australian Data

Australia’s Therapeutic Goods Administration (TGA) is planning to run a good clinical practice (GCP) inspection pilot program. TGA sees the pilot as a stepping...
Guidance for TGO 101

Australia – Guidance for TGO 101

This guidance is to help sponsors and manufacturers of medicines understand the role of the Therapeutic Goods Order No. 101 - Standard for tablets, capsules...

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