Search Results Summary:
-
About the Guidelines
funding of a new medicine or medicinal product as part of the Pharmaceutical Benefits Scheme (PBS).
The PBAC considers submissions from industry sponsors of medicines and medicinal products, medical bodies, health professionals, and private individuals and their representatives. However, for new
pbac.pbs.gov.au/information/about-the-guidelines.html
Page last updated: September 2016
-
1.3 Regulatory process
All new pharmaceutical products must be registered on the Australian Register of Therapeutic Goods (ARTG) by the TGA before being marketed in Australia.
State the indication(s) approved by the TGA. These are identified in the ‘Indications’ section of the product information and are listed in the ARTG.
pbac.pbs.gov.au/section-1/1-3-regulatory-process.html
Page last updated: September 2016
-
Product type 3 – Vaccine products
Product type 3 – Vaccine products
pbac.pbs.gov.au/product-type-3-vaccine-products.html
Page last updated: September 2016
-
Submission executive summary
pharmacological action of the proposed medicine[Yes/No] The form(s), strength(s), pack size(s), maximum quantity(ies), number(s) of repeats and dispensed price(s) requested for PBS listing[Yes/No] The proposed
pbac.pbs.gov.au/submission-executive-summary.html
Page last updated: September 2016
-
P3.1 Details of the proposed vaccine and its comparator (Section 1)
See Product type 1 for the additional information requests for submissions containing fixed combination vaccine products. As mentioned in Subsection P1.1, the component products that prevent
Identify and justify any differences from treatment recommendations in the TGA-approved product information or the Australianimmunisation handbook (the Handbook). The Handbook is endorsed
Page last updated: September 2016
-
4.3 Estimation of changes in use and financial impact of other medicines
, particularly where there is differential pricing across the PBS-listed medicines.
Page last updated: September 2016
-
Document table
Document table Document requestedaReference to submission appendix or attachment Regulatory[add] Most recent version of the (draft) product information[add] Therapeutic Goods Administration (TGA
pbac.pbs.gov.au/information/document-table.html
Page last updated: September 2016
-
References
for industry: patient-reported outcome measures – use in medical product development to support labeling claims. Rockville, MD: US Department of Health and Human Services, Food and Drug Administration, Center
clinically important difference: a review of concepts and methods. Spine J 2007;7(5):541–6. European Medicines Agency Committee for Medicinal Products for Human Use (CHMP). Guideline on the choice of the non
pbac.pbs.gov.au/information/references.html
Page last updated: September 2016
-
1.1 Clinical issue addressed by the submission
the evidence justifying the claim for the difference in responses for different populations and therefore for the alternative comparator whether the price of the proposed medicine reflects
pbac.pbs.gov.au/section-1/1-1-clinical-issue-addressed_by-the-submission.html
Page last updated: September 2016
-
3B.2 Estimation of equi-effective doses
Indicate whether these data are consistent with those recommended in each medicine’s TGA-approved product information about:
pbac.pbs.gov.au/section-3b/3b-2-estimation-of-equi-effective-doses.html
Page last updated: September 2016
