You are here

Annual performance statistics report: July 2016 to June 2017

12 September 2017

Book pagination

4. Biologicals

The Australian Regulatory Guidelines for Biologicals define the different biological classes.

4.1. Inclusion of biologicals

Table 24 Applications for biologicals received and on hand
  2015-16 2016-17
July to June
Applications received
Technical Master File (TMF)a new 2 0
TMF annual updates 6 5
TMF variations 9 20
TMF notifications 7 27
Plasma Master Fileb annual updates 15 11
Biological Class 2 - new applications 2 4
Biological Class 3 - new applications 2 0
Biological Class 2 - variations 26 14
Biological Class 3 - variations 2 1
Total received 71 82
Applications on hand
TMF new 2 1
TMF annual updates 4 4
TMF variations 2 7
TMF notifications 0 0
Plasma Master File annual updates 3 4
Biological Class 2 - new applications 3 6
Biological Class 3 - new applications 4 3
Biological Class 2 - variations 7 2
Biological Class 3 - variations 1 0
Total on hand 26 27
  1. Technical Master Files (TMF) contain information from manufacturers that demonstrate how product safety and quality standards have been met for Blood, Blood Components and Haematopoietic Progenitor Cells.
  2. Plasma Master Files contain control strategies that ensure the quality and safety of plasma, from collection through to plasma pooling prior to fractionation and including donor selection criteria and testing, which are part of medicinal products or medical devices.
Table 25 Completed applications for biologicals
  2015-16 2016-17
July to June
Biologicals applications
Technical Master File (TMF) new 2 1
TMF annual updates 5 5
TMF variations 7 19
TMF notifications 7 27
Plasma Master File annual updates 14 7
Biological Class 2 - new applications 4 1
Biological Class 3 - new applications 0 1
Biological Class 2 - variations 21 18
Biological Class 3 - variations 5 2
Total completed 65 81

Book pagination