CORONAVIRUS : India halts exports of about 2 dozen APIs, drugs

India – Indian pharma to focus on quality to remain a world leader

The US Trade Representative (USTR) has questioned India for the country’s growing spurious medicine problem. According to the USTR report, nearly 20% of all...
TGA Updates Guidance on the Testing of Biological Medicines

Australia – Artificial Intelligence Can Save Pharmacovigilance in Australia

For healthcare professionals in Australia, pharmacovigilance is a mix of centralized and decentralized processes. The pillar of these processes is the spontaneous report. In...

USA – Indian drugmaker gets warning letter from FDA

The US Food and Drug Administration (FDA) hit Indian drugmaker Aurobindo with a warning letter for inadequately investigating batch failures related to its manufacturing...
Hong Kong regulator will continue to recognize South Korean approvals

China – Experts suggest new method for assessing imported generic drugs in China

According to researchers, a newly developed strategy could improve the quality of generic drugs by assessing process control and process risk. In addition to...
Principe des 3R : avancées de la Commission européenne de Pharmacopée ces dix dernières années

China – Clinical evaluation authority, plus guidelines for animal testing studies

The National Medical Products Administration (NMPA), China’s medical device market regulator, has revealed plans to set up a technical division focused on clinical evaluation...

Asia – Asia-Pacific Roundup: India okays a handful of FDCs as long saga continues

India’s Central Drugs Standard Control Organization (CDSCO) has deemed 31 fixed-dose combinations (FDCs) as rational some 14 years after India ordered the withdrawal of 294 FDCs...
CORONAVIRUS : India halts exports of about 2 dozen APIs, drugs

India – Pharmaceutical supply disruptions predicted in India

The pharmaceutical industry in Tamil Nadu foresees the months ahead in 2021 will be critical for the production and supply of pharmaceuticals because the...
TGA Updates Guidance on the Testing of Biological Medicines

Australia – TGA international engagement strategy 2021-2025

The Therapeutic Goods Administration (TGA), as part of the Australian Department of Health, supports the Department's strategic priorities for an affordable, accessible, efficient and...

Asia – Asia-Pacific Roundup: Malaysia publishes guidance on manufacturing cell and gene therapies

Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has released guidance about cell and gene therapy manufacturing facilities. The guidance describes the process for setting up...
Home-grown colorectal cancer drug approved in China

China – China announces new guidelines for oncology drugmakers

The US has long been the leader in research and development in oncology, but homegrown Chinese drugmakers have jumped one hurdle after another in...

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