Australian manufacturing licences and overseas GMP certification

Australia – Australian manufacturing licences and overseas GMP certification

This step-by-step guide is for: Australian manufacturers of therapeutic goods (medicines, active pharmaceutical ingredients (APIs) and biologicals, human blood and blood components and haematopoietic...
Australian manufacturing licences and overseas GMP certification

Australia – Updated GMP licence application e-forms

The revised fees and charges model for domestic medicine manufacturers commenced on 1 July 2018. To fully support these changes the TGA needed to update our...
China may launch trials on new gene-editing technology within 2 years

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 Floats Tighter Clinical Trial Oversight Following Gene Editing Scandal

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 Advances Plan to Create Mobile Drug Testing Laboratories

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...
Indian regulators tweak drug trial rules

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...
China Floats Tighter Clinical Trial Oversight Following Gene Editing Scandal

China – China plans to reduce VAT for rare disease therapies

An executive meeting of China’s State Council outlined plans to reduce the value-added tax on domestic and imported rare disease drugs, improve cancer treatment...
Australian manufacturing licences and overseas GMP certification

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...
TGA Brings 6 Guidance Documents in Line With PIC/S Guide to GMP

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...
Australian manufacturing licences and overseas GMP certification

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...

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