Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
The Learning Portal will be under maintenance Monday, 6 December between 6 AM and 5 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.
Posted 10 July 2014 | By Louise Zornoza,
Australia’s Therapeutic Goods Administration (TGA) has issued an amended bioequivalence guidance document applicable to all prescription medicines except for biologicals.
The guidance includes European Union guidelines that have been adopted by the TGA, such as the investigation of bioequivalence, the quality of modified release dosage forms, modified release oral and transdermal dosage forms, and the clinical investigation of the pharmacokinetics of therapeutic proteins.
The guidance is intended to assist sponsors of prescription medicines to prepare applications to register new prescription medicines, or vary the registration of an already approved prescription medicine.
This content is provided by RegLink Associates. Read all of their Breaking News alerts on their website.
Tags: Bioequivalence, Guidance
Regulatory Focus newsletters
All the biggest regulatory news and happenings.