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 firstname.lastname@example.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.
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 27 June 2013 | By Alexander Gaffney, RAC,
Australia's Therapeutic Goods Administration (TGA) has become the latest global regulatory agency to look to better define what it considers to be commercially confidential information (CCI), launching a new consultation on 27 June 2013 that explains in extensive detail what such information is-and just as importantly, is not.
The document, Draft TGA Approach to Disclosure of Commercially Confidential Information, may be most notable for the information it says it will not release to the public: clinical data.
In recent months, a bevy of regulators, including those in the EU and US, have taken steps (and in the case of the EU, large ones) toward releasing clinical data to additional experts and the public in general. Australia, however, appears to be re-affirming that such data is considered CCI under established practices.
"Commercially confidential information held by the TGA may include … certain information about clinical trials," TGA writes in the document, including the "outcome of testing of a product or investigations into its performance."
In addition, commercial entities will have avenues to contest the release of any information they believe to be CCI. "Any decision to release information to the public on a regular or systematic basis about any aspect of its regulatory functions that could involve the release of commercially confidential information will be preceded by consultation with affected stakeholders and the release appropriately authorized under legislation," TGA wrote.
The document goes on to list eight "principles" of CCI:
The consultation on the document is open through 29 August 2013.
Draft TGA Approach to Disclosure of Commercially Confidential Information
Tags: CCI, australia, clinical trials
Regulatory Focus newsletters
All the biggest regulatory news and happenings.