Regulatory reforms proposed for prescription medicines
Consultation on regulatory reforms for the prescription medicines sector - Thursday 24 July 2008
Discussion on key reform areas
General agreement was reached to progress the regulatory reforms proposed in the key areas listed below and separately set out in the common areas for reform <http://www.tga.gov.au/regreform/common.htm>. Specific matters for this product sector are outlined below.
Matters raised were addressed by a TGA panel comprising:
| Dr Rohan Hammett | National Manager, TGA |
| Dr Ruth Lopert | Acting Principal Medical Adviser |
| Mr Charles Maskell-Knight | Principal Adviser, Regulatory Reform |
| Dr Leonie Hunt | Head, Office of Prescription Medicines |
| Dr Gary Lacey | Head, Office of Medicines Safety Monitoring |
| Dr Mark Doverty | Head, Office of Manufacturing Quality |
| Mr Pio Cesarin | Head, Office of Non-Prescription Medicines |
| Ms Christine Bell | Head, Executive Support Unit |
| Mr Michael O'Connor | Director, Parliamentary and Regulatory Operations Section |
Participants were asked to note this would be the final public consultation on the proposed reforms except where otherwise indicated.
Readers are encouraged to read this document in conjunction with the reforms common across all therapeutic product sectors <http://www.tga.gov.au/regreform/common.htm> and with the presentation for this sector <http://www.tga.gov.au/regreform/common.htm#pres>.
1. Legislative amendments deferred in anticipation of the Joint Regulatory Scheme
These issues are covered in common reforms <http://www.tga.gov.au/regreform/common.htm>.
2. Opportunities for reducing regulatory burden
These issues are covered in common reforms <http://www.tga.gov.au/regreform/common.htm>.
3. Increasing transparency and the access to information
These issues are also covered in common reforms <http://www.tga.gov.au/regreform/common.htm>.
Access to Product and Consumer Information
Participants noted that the TGA would be publishing Consumer Medicines Information (CMI) and Product Information (PI) documents for prescription medicines on the TGA's website in order improve access to such information for consumers and health professionals. Consideration may be given to aligning the Australian format with that used overseas in the future, in consultation with industry.
AusPAR
Participants noted that there had been considerable discussion in conjunction with peak stakeholder representatives regarding options for increasing the transparency of the prescription medicines regulatory process. The option proposed for adoption is the Australian Public Assessment Report (AusPAR) which is based on the European Public Assessment Report (EPAR) model.
TGA is currently looking at options to implement this model with further consultation expected.
ADEC hearings
The TGA advised that the ADEC hearings would provide sponsors with the opportunity to present expert opinion to the Committee on matters of contention. Participants considered that the move to improve transparency of ADEC processes was a welcome reform.
4. Enhancements to post-market monitoring
These issues are covered in common reforms <http://www.tga.gov.au/regreform/common.htm>.
5. Future directions
Business redesign
TGA advised participants of the proposed enhancements to TGA's IT capability, including full lodgement of electronic submissions and tools to support streamlined review processes.
Electronic Common Technical Documentation (e-CTD)
Participants noted that the TGA expects to issue a request for tender for IT support for the lodgement of the eCTD, initially via disc or other memory device, in the first half of 2009.
Access to Medicines Working Group (AMWG)
Participants noted the AMWG is working on better streamlining and coordinating of TGA and PBAC processes to reduce the time it takes to list a medicine on the PBS.
Streamlining of review processes
Changes to introduce a pre-submission phase and reduce filtering, and a review of business rules around coordination of formal questions at the completion of an initial review, have been discussed with industry and will proceed to further consultation on implementation options.
Presentation
Presentation 24 July 2008: Regulatory reforms proposed for prescription medicines (pdf,182kb)
**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 they relate. The papers are 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 papers 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 papers.**