New Zealand – Guidelines on the Regulation of Therapeutic Products in New Zealand
Medsafe requires evidence of compliance with Good Manufacturing Practice (GMP) for sites
used to manufacture and pack medicines. This evidence is required for medicines in...
Australia – Nitrosamine risk assessment in Category 1 prescription medicine registration applications
Sponsors need to be aware of the global issue relating to nitrosamine impurities in medicines. In particular, they should be familiar with the known...
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...
