TGA Plans GCP Inspection Program

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...
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...
China FDA Reorganization: Impact for medical device registrants

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),...
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...
China FDA Reorganization: Impact for medical device registrants

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...
Liste des ingrédients en Chine

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...
Liste des ingrédients en Chine

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...
S. Korean officials extend seasonal flu vaccine to very young children

South Korea – S. Korean officials extend seasonal flu vaccine to very young children

C Pharma (formerly known as Green Cross) has announced that it has received approval from the South Korean Ministry of Food and Drug Safety...
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,...
Mylan recalls 15 lots of blood-pressure drug containing valsartan

China – Third Form 483 Surfaces for China Company at Center of Valsartan Contamination

Just days since FDA, EMA and Health Canada announced that a second impurity, called N-nitrosodiethylamine (NDEA), has been found in valsartan manufactured by Zhejiang Huahai Pharmaceuticals...

NOS PROCHAINES FORMATIONS