TGA News Issue 52 (March 2007) - General news
Clinical trials & unapproved products
The Australian Government Response to the recommendations of the review of clinical trials and access to unapproved therapeutic goods (the Bansemer Report) is now available <http://www.tga.gov.au/pmeds/bansemer-rep.htm>
NDPSC update
The National Drugs and Poisons Schedule Committee Guidelines have been updated. <http://www.tga.gov.au/ndpsc/ndpscg.htm>
The NDPSC meeting and gazettal dates for February 2007 to June 2008 are now available. <http://www.tga.gov.au/ndpsc/meetings.htm>
Gazette notices <http://www.tga.gov.au/ndpsc/ndpscgan.htm> associated with the October 2006 and the February 2007 meetings of the NDPSC and the record of reasons for the October 2006 meeting <http://www.tga.gov.au/ndpsc/record/rr200610.htm> are available.
Payment of fees & charges
The TGA provides a range of payment options for regulatory fees and charges and other amounts. One of the options is electronic funds transfers directly into the TGA's bank account following completion of an Electronic Funds Transfer Agreement Form <http://www.tga.gov.au/fees/forms/eft.htm>. The form includes the TGA's current Westpac bank account details.
Sponsors are advised that the TGA closed its old Reserve Bank account in the first week of February 2007 and no further payments into this account can be accepted.
Sponsors are reminded that the TGA has an online payment option for the payment of annual charges over the Internet - this is the preferred payment option where available.
For further information about payment options, see the TGA website <http://www.tga.gov.au/docs/html/feesach.htm>.
Recalls
One consumer-level medicine recall and three consumer-level medical device recalls have occurred since the last issue of TGA News <http://www.tga.gov.au/recalls/index.htm>.
Strategic & business plans
Now available on the TGA website:
- TGA Strategic Plan 2006-2008 <http://www.tga.gov.au/about/tgasp0608.htm>
- July-September 2006 quarterly report against the TGA Business Plan 2006-2007 <http://www.tga.gov.au/about/tgabp0607.htm>
TGO
Therapeutic Goods Order No. 70B Standards for Export Only Medicine <http://www.tga.gov.au/docs/html/tgo/tgo70b.htm> has been registered with the Federal Register of Legislative Instruments and is now in force. It revokes TGO70 and TGO70A.