Prescription medicines business process reform project
9 March 2010
Information sessions
February 2010
The TGA conducted public information sessions to provide people with an opportunity to gain a detailed understanding of the proposed new streamlined submission process for prescription medicines and discuss any issues/concerns that they have. A consultation paper <http://www.tga.gov.au/pmeds/consult/cons-pmssp.htm> is available on the TGA website, with submissions on the proposed process requested by 5pm on Monday, 22 March 2010.
The sessions were held in:
- Melbourne on 17 February 2010
- Sydney on 24 February 2010
- Brisbane on 26 February 2010
Please note: This is the presentation provided in Brisbane. Minor refinements, mainly in sequencing, were made to the slides from the earlier presentations.
Presented by:
- Dr Rohan Hammett, TGA National Manager TGA (Melbourne and Sydney)
- Pio Cesarin, Head of the Office of Prescription Medicines (Melbourne, Sydney and Brisbane)
- Industry representatives from Medicines Australia and GMIA
**This presentation paper is provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The paper is not legislative in nature and should not be taken to be statements of any law or policy in any way.
The Australian Government Department of Health and Ageing (of which the TGA is a division) advises that (a) the presentation paper should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation paper.**
Background
A Project Team was established to implement the Business Process Reform (BPR) Project for prescription medicines early in 2009. Key reforms have been on the TGA change agenda for a number of years - previous reviews and consultation have occurred, including planning for the Australia New Zealand Therapeutic Products Authority (ANZTPA), which did not proceed.
The BPR Project focuses on initiatives that were developed at an Access to Medicines Working Group workshop held on 17 December 2007, involving representatives of the TGA, Medicines Australia and the Department of Health and Ageing. The workshop looked at the arrangements for processing applications to both the TGA and Pharmaceutical Benefits Advisory Committee (PBAC) and discussed potential changes to reduce the time it takes to list new medicines on the Pharmaceutical Benefits Scheme.
BPR project
The key initiatives are as follows:
- Accelerated application entry and improved application coordination: from a streamlined submission process <http://www.tga.gov.au/pmeds/pmbpi-submissionprocess.htm>
- by replacing the 40 day application entry process with an improved pre-submission process
- through better application coordination.
- Improved access to prescription medicine information <http://www.tga.gov.au/pmeds/pmbpi-improvedaccess.htm> - for consumers and health professionals by facilitating access to a comprehensive source of up to date Consumer Medicine Information (CMI) and Product Information (PI) via the TGA website.
- Increased transparency of the prescription medicine regulatory process <http://www.tga.gov.au/pmeds/pmbpi-transparency.htm> - through publication of an Australian Public Assessment Report (AusPAR) for major decisions on the TGA website.
The implementation of these initiatives will improve the regulation of prescription medicines in Australia. By improving the practice of regulation, the TGA will have the capacity to implement the broader regulatory reform agenda agreed to by the Australian government <http://www.tga.gov.au/regreform/index.htm>.
In addition, from 1 April 2009, the TGA has introduced an initiative in which sponsors of prescription medicine products may be required to submit a Risk Management Plan (RMP) for more information refer to: Risk management plans for prescription medicines <http://www.tga.gov.au/pmeds/rmplans.htm>.
Consultation
- Requirements for the prescription medicine streamlined submission process <http://www.tga.gov.au/pmeds/consult/cons-pmssp.htm>
closes 22 March 2010
Since April 2009, the TGA has been working with an Industry Working Group (IWG) who have assisted in developing concepts and identifying issues that need to be considered. Consultation has also occurred with various industry bodies including Medicines Australia, the Generic Medicines Industry Association, AusBiotech and the Consumer Health Forum. Several documents have been released for public consultation.
TGA-Industry Working Group (IWG)
Prescription medicine business process reform project
Industry members
| Representative | Contact email address |
|---|---|
| Susan Alexander | susan.alexander@roche.com |
| Warren Back | warren_back@merck.com |
| Helen Critchley | helen.critchley@abbott.com |
| Elizabeth de Somer | elizabeth.desomer@medicinesaustralia.com.au |
| Damien Gallagher | damien.gallagher@ascentpharma.com.au |
| Karen James | jamesk@wyeth.com |
| Kirpal Kaur | kirpal.kaur@bms.com |
| Kate Lynch | kate.lynch@gmia.com.au |
| Andrew Notley | andrew.notley@gilead.com |
| Duncan Purvis | dpurvis@its.jnj.com |
| Piety Rocha | piety.rocha@alphapharm.com.au |
| Sylvia Roins | Sylvia.Roins@pfizer.com |
| Mark Rowland | mrowland@amgen.com |
| Tony Whittaker | tony.whittaker@commercialeyes.com.au |
IWG outcomes
Information about the project
- Letter sent to prescription medicine sponsors (pdf,94kb)
<http://www.tga.gov.au/pmeds/opm-bprproject-letter091110.pdf>
An update of progress with each key initiative sent to prescription medicines sponsors on 10 November 2009
Please note that the TGA is currently developing guidance for the streamlined submission process and wants to formally consult with people before the new process becomes mandatory. To allow time for this consultations to occur, the TGA is delaying the implementation date for the streamlined submission process until mid 2010 - the date is still to be finalised.
*Large file warning: Attempting to open large files over the Internet within the browser window may cause problems. It is strongly recommended you download this document to your own computer and open from there.
- OPM regulatory framework v.1.15 (pdf,344kb)
<http://www.tga.gov.au/pmeds/opm-bprproject-regulatoryframework-flowchart.pdf>
This flow chart provides a high-level depiction of how the new end-to-end life-cycle of a submission will work - **Presentation: Prescription medicines business process improvement project presentation (pdf,225kb)
<http://www.tga.gov.au/pmeds/pmbpi.pdf>
This powerpoint presentation was presented at industry briefings during April-May 2009 - **Presentation: Business process reform project for the Office of Prescription Medicines (pdf,1.1Mb)*
<http://www.tga.gov.au/pmeds/pres-bprproject.pdf>
This powerpoint presentation was presented for industry briefings held in July 2009.
**These presentation papers are provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The paper is not legislative in nature and should not be taken to be statements of any law or policy in any way.
The Australian Government Department of Health and Ageing (of which the TGA is a division) advises that (a) the presentation paper should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation paper.**
More information
To obtain more information you can:
- Subscribe to receive an email that tells you when updates are made to the TGA website - as new information on the BPR Project is released this website is updated.
<http://www.tga.gov.au/new/tga-update-subscribe.asp> - email the Business Process Reform team with questions/queries.