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.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
| 06 June 2013 | By Louise Zornoza
Australia's Therapeutic Goods Administration (TGA) has opened a consultation on how best to address concerns that the current regulatory framework for compounding medicines does not provide adequate assurance that they meet acceptable standards of quality and safety.
The TGA notes that the expansion of pharmaceutical compound manufacturing in Australia reflects international trends, and that there are concerns locally and overseas regarding the complexity and scale of manufacture in pharmacies that was not envisaged when current regulatory arrangements were put in place. The deadline for comments is 17 July 2013.
The options proposed in the consultation are:
The last option includes three sub-options, based on either sterility or the complexity of the medicine, or the scale of manufacturing activity.
TGA Compounding Proposals
Read all Breaking News from RegLink
Tags: Pharmaceutical Compounding, Compounding, australia