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 raps@raps.org 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.
RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.
Posted 28 August 2012
Australia's Therapeutic Goods Administration (TGA) has released revised guidance on the evidence required to support indications made for over-the-counter (OTC) medicines.
The revised version now permits two ways to provide supporting evidence to the TGA: established sources, such as comprehensive evidence reviews conducted by international regulators (Sources of Established Evidence or "SEE"), or full systematic reviews conducted by the product sponsor where established sources do not exist (Evidence Report).
The new guidance includes essential steps required during the consideration of a SEE, and during the development and fulfillment of the requirements of an Evidence Report. This includes guidance about literature searching, and the assessment of the level, relevance, quality, outcomes and overall balance of currently available evidence.
In recognition of evidence used to support indications for listed medicines is often obtained from the available literature rather than sponsor-initiated clinical trials specifically conducted with a proposed product, a large portion of the guidance is dedicated to providing direction on the assessment of the relevance of scientific and evidence of traditional use to a proposed indication.
Read more
Tags: OTC, medicines, australia, guidance