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 regulator will continue to recognize South Korean approvals

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

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...
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...
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...
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...
China’s NMPA Launches Voluntary Device Master File Process

China – Chinese API Manufacturer Refuses EU Officials’ Inspection

China-based active pharmaceutical ingredient (API) and intermediate manufacturer Jiangsu Yew Pharmaceutical Co. has refused an inspection by Hungarian officials and has been found to...
FDA Finalizes Guidance on Nonclinical Drug Development for Serious Hematologic Disorders

Asia – Six Asian Firms Blocked for Refusing FDA Inspections

Four Chinese, one Indian and one South Korea-based drug manufacturer have been added to the US Food and Drug Administration’s (FDA) import alert list...

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