Industry Issues

Pharmacovigilance Guideline - Delay of Implementation Date
The TGA had advised the release of the draft Australian guideline for pharmacovigilance responsibilities of sponsors of medicines has been delayed. To access the document click here.

Pharmacovigilance Presentations (login required)
Please note that information contained in the slides (Click Here) represent the view of the presenters on the subject matter and should not be taken as the sole reference for guiding individual companies to fulfil pharmacovigilance obligations.  Companies should refer to applicable regulatory source documents and consider seeking independent advice to develop their own pharmacovigilance system.

Requirements for Reporting Non-Serious Adverse Events for Prescription and Non-Prescription Medicines
To assist industry, the CHC provides a letter from the TGA which clarifies the situation on adverse event reporting requirements. To access the document click here

Crisis Management Guidelines September 2010 Edition 26
Please note the new edition of the Crisis Management Guidelines are now available, with up to date contacts list in Appendix 1-3. To access the document click here

PIC/S Code of GMP - Letter for Sponsors
To assist industry, particulalry sponsors, with the new changes being implemented with the adoption of the new PIC/S Code of GMP (effective 1 July 2010), the CHC and ASMI have outlined some changes to note in a letter (March 2010)

Advice to Members on Diversion of Ingredients for Illicit Drug Use
The CHC was contacted in regards to incidences of complementary medicine ingredients being diverted into illicit drug manufacturing. To assit industry's awareness, the CHC created a document on the Diversion of Precursor Chemicals/Equipment into Illicit Drug Manufacture (August 2008)

Codex - what are the facts in relation to Australia?
Due to concern from members, the CHC created an information sheet about Codex to help clarify its role in relation to Australia – “the facts without the fiction” (July 2008)