Australia – TGA Overhauls Guidance on Risk Management Plans for Medicines and Biologicals
Australia’s Therapeutic Goods Administration (TGA) has overhauled its guidance on risk management plans (RMPs) for medicines and biologicals. The guidance features significant changes to...
India – Indian regulators waive clinical trials for drugs approved elsewhere
New drugs approved for use in EU, UK, Australia, Japan and US will be automatically allowed in India, provided clinical trials included Indian...
China – China may launch trials on new gene-editing technology within 2 years
China could be just over a year away from clinical trials of a new gene-editing therapy with an unprecedented high level of safety, according...
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...
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...
India – Indian regulators tweak drug trial rules
The latest set of clinical trial rules, likely to be notified in March, will fast-track proposal clearances for Indian companies rather than their multinational...
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...
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...
Australia – TGA Plans GCP Inspection Program to Ensure Global Recognition of Australian Data
Australia’s Therapeutic Goods Administration (TGA) is planning to run a good clinical practice (GCP) inspection pilot program. TGA sees the pilot as a stepping...
New Zealand – New Zealand Pushes Ahead With Paracetamol Reclassification Despite Objections
Regulators in New Zealand have reaffirmed their intention to reclassify modified-release paracetamol as a restricted medicine. Officials proposed strengthening the restrictions on the medicine...
