Australia Implements EU Drug Guidelines

Australia’s Therapeutic Goods Administration has adopted 10 EU guidelines, four that are new for the country and six that replace existing guidelines.

The four new guidelines address quality risk management, drug quality systems, stability testing and the use of genetically modified animal models.

The replacement guidelines discuss active substance master file procedures, similar biological products, nonclinical and clinical issues for biosimilars, evaluation of drugs to treat irritable bowel syndrome, quality of transdermal patches, and pharmacokinetic and clinical evaluation of modified-release dosage forms.

Adoption of the guidelines, announced last week, follows a consultation that ended May 22. Most of the guidelines became effective May 25, although two of them take effect in June and one takes effect in July.

Access the guidelines here: www.fdanews.com/06-15-TGA-Guidelines.pdf. — Jonathon Shacat