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Submissions received: Whether the TGA should publish that a prescription medicine is under evaluation
Between 15 February and 29 March 2019, the TGA sought comments from interested parties on the public consultation paper "Whether the TGA should publish that a prescription medicine is under evaluation".
A total of 39 submissions were received from industry, health professionals, consumer representative groups, regulatory consultants and government.
We thank individuals and organisations for their submission and valuable feedback. All submissions that were not marked as confidential are now available in PDF format.
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- Consultation submission: AbbVie Pty Ltd (pdf,264kb)
- Consultation submission: Aspen Pharmacare Australia Pty Ltd (pdf,76kb)
- Consultation submission: Astra Zeneca Pty Ltd (pdf,343kb)
- Consultation submission: Australian Commission on Safety and Quality in Health Care (pdf,995kb)
- Consultation submission: Australian Medical Association (pdf,183kb)
- Australian Medicines Handbook Pty Ltd
- Consultation submission: Biogen Australia Pty Ltd (pdf,327kb)
- Consultation submission: Bristol-Myers Squibb (pdf,335kb)
- Capital K Consulting
- Consultation submission: Consumers Health Forum (pdf,38kb)
- Generic Health Pty Ltd
- Consultation submission: GlaxoSmithKline (GSK) (pdf,140kb)
- Consultation submission: Johnson & Johnson Pty Ltd (pdf,610kb)
- Juno Pharmaceuticals Pty Ltd
- Consultation submission: Medicines Australia (pdf,192kb)
- Consultation submission: Merck Sharp ∓ Dohme Australia Pty Ltd (pdf,240kb)
- Consultation submission: Merck Serono Australia (pdf,217kb)
- Consultation submission: Painaustralia Ltd (pdf,74kb)
- Consultation submission: Pfizer Australia Pty Ltd (pdf,317kb)
- Consultation submission: Pharmaceutical Policy Network (pdf,148kb)
- Consultation submission: Patient Voice Initiative (pdf,276kb)
- Consultation submission: Perrigo Australia (pdf,76kb)
- Queensland Health
- Consultation submission: Roche Products Pty Limited (pdf,207kb)
- Consultation submission: Royal Australian and New Zealand College of Ophthalmologists (RANZCO) (pdf,176kb)
- Consultation submission: Teva Pharma Australia Pty Limited (pdf,448kb)
- Consultation submission: The Society of Hospital Pharmacists of Australia (pdf,82kb)
- Consultation submission: Western Australian Drug Evaluation Panel (pdf,223kb)
- Whittaker, Dr Tony, Pharmaceutical Consultant
A further five submissions were received with claims of confidentiality or privacy that prevent the publication of the submissions and the identities of those providing submissions.
Response and next steps
The Australian Government has given approval to proceed with implementation of enhanced transparency measures for prescription medicines, in response to public demand for more information on prescription medicines that are under evaluation. Two measures are proposed:
- Measure 1: Early publication of major innovator medicine applications: This measure will introduce earlier publication of major innovator prescription medicines that have been accepted for evaluation under section 25 of the Act. The measure will provide information on potential availability of new medicines, or new uses for medicines and new combinations (where one active ingredient is a new medicine). Publication will occur from June 2020.
- Measure 2: Earlier notification of generic medicine applications to the innovator: This measure will introduce earlier notification of generic medicine applications to the innovator. Implementation is planned for early 2021.
The TGA is seeking feedback from sponsors on implementation options for these measures, commencing 27 March and ending 9 June 2020.
- Prescription medicines transparency measures: Implementation of generic medicines early notification to innovators of an application and publication of innovator applications (pdf,211kb)
- Prescription medicines transparency measures: Implementation of generic medicines early notification to innovators of an application and publication of innovator applications (docx,98kb)
Questions relating to these measures should be directed to the Application and Advisory Management Section by email to: email@example.com.