European Commission Confirms Quality of South Korean Active Substances

South Korea – European Commission Confirms Quality of South Korean Active Substances

The European Commission this week confirmed that the quality of active substances produced in the Republic of Korea are in line with EU standards. South...
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...
China’s NMPA reports major decrease in medical device approvals

China – China Floats Tighter Clinical Trial Oversight Following Gene Editing Scandal

China is planning to introduce a risk-based regulatory system for cell and gene therapies in the wake of the germline modification scandal. The system...
TGA Brings 6 Guidance Documents in Line With PIC/S Guide to GMP

Australia – TGA Brings 6 Guidance Documents in Line With PIC/S Guide to GMP

TGA has updated six guidance documents to bring them into line with the Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP guide, PE 009-13. Most of...
How trade war with China could hit US pharmaceutical makers

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...
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...
CDSCO Creates Process for Companies That Lack Data Supporting Their FDCs

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...
China’s NMPA reports major decrease in medical device 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...
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...
How trade war with China could hit US pharmaceutical makers

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...

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