Healthy Skepticism Library item: 17231
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Streamlined TGA
Pharmacy Daily 2010 Feb 8
http://www.pharmacydaily.com.au
Full text:
THE Therapeutic Goods Administration is inviting interested parties to comment on proposed changes to the way prescription medicines are evaluated, under a ‘streamlined submission’ process.
Currently it takes on average 500 days for a new prescription medicine to be approved by the TGA, but the new process aims to reduce this significantly, to around 300 days, by “eliminating unnecessary queues and delays in the evaluation process that have developed over time.”
The changes will also require the TGA to provide clear requirements for an effective submission.
Details of the new process are contained in a consultation paper which is now online at tga.gov.au, and submissions are due by 5pm on Mon 22 Mar 2010.
