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...
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...
Brazil – ANVISA approves skinny labeling in Brazil
On December 6, the Board of Directors (DICOL) of the Brazilian Food & Drug Agency (ANVISA) passed new regulations accepting an exemption to allow...
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...
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...
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...
