Drugmakers in Australia would need to establish drug quality systems under a guideline regulators plan to adopt from the EU.
The guideline is one of 10 EU guidelines the Therapeutic Goods Administration is looking to adopt. Four of them, including the quality systems guideline, are new to the country’s drug industry. The other new guidelines cover quality risk management, stability testing for applications for variations to a marketing authorization and recommendations on the use of genetically modified animal models to assess cancer risks.
The other six guidelines replace existing TGA guidelines. They address active substance master file procedures, similar biological products, nonclinical and clinical issues for biosimilars containing biotechnology-derived proteins as active substance, evaluation of drugs to treat irritable bowel syndrome, pharmacokinetic and clinical evaluation of modified-release dosage forms, and quality of transdermal patches.
This is not the first time the TGA has looked to the EU for how to provide guidance to industry. Last June, the agency sought feedback on 15 European guidelines — eight of them new to Australia — and in July it adopted EU pharmacovigilance guidelines.
Comments on the proposal are due May 22. Access the list of guidelines at www.fdanews.com/04-15-TGA-Consultations.pdf. — Jonathon Shacat