GMP Clearance Guidance
TGA Clearance applications for overseas manufacturers are now required to [...]
eBS Permitted Indications
Effective March 8th 2018 Permitted indications are now available through [...]
TGA eBS Outage
The Therapeutic Goods Amendment Bill No.1. of 2017 received royal [...]
Changes to the Uniform Recall Procedure for Therapeutic Goods
The Uniform Recall Procedure for Therapeutic Goods (URPTG) is a [...]
Consultation: Business Process Improvements Supporting Complementary Medicines Assessment Pathways
The TGA is seeking comments from interested parties on a [...]
Updated Permissible Ingredients Determination
An updated version of the Therapeutic Goods (Permissible Ingredients) Determination [...]
Pharmacovigilance Update
On 1st September 2017, the TGA published the revised edition [...]
Listed Medicine Reforms – Permitted Indications and Application Fees
Permitted Indications The closing date for proposing additional indications or [...]
Third Assessment Pathway for Listed Complementary Medicines
Intermediate Level – Listed Assessed Medicines Reform recommendations for complementary [...]
Labelling Revised – Amendments to the Therapeutic Goods Order No. 92
The four-year transition period for the new labelling requirements (from [...]