Singapore – Singapore’s HSA finalizes LDT guidelines
Singapore’s Health Sciences Authority (HSA) has finalized guidance intended to help clinical laboratories understand the regulatory requirements for tests they develop internally.
To date, HSA...
India – Indian Pharmacopoeia joins global discussion group pilot
The international Pharmacopoeial Discussion Group (PDG) has accepted the Indian commission into a one-year pilot that is intended to expand its membership beyond the...
Asia – 3D-printed drug advancing to clinical trials in SE Asia
Craft Health’s tailored drug technology just received a boost. The Singapore 3D printed pharmaceuticals manufacturer announced it has raised S$1.42 million ($1.03 million) in...
USA – Industry asks FDA to expand scope of product quality assessment guidance
Stakeholders want the US Food and Drug Administration (FDA) to include biosimilars and other biologics regulated by the Center for Biologics Evaluation and Research...
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...
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...
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...
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...
