Submissions received: Guidance on risk management plans for medicines and biologicals
Australian requirements and recommendations
Between 31 October and 16 December 2016, the TGA sought comments from interested parties on draft guidance on Risk management plans for medicines and biologicals - Australian requirements and recommendations.
A total of four submissions were received from the consultation. Of the submissions, there were three from manufacturers/sponsors and one from an industry group. The TGA thanks those individuals and organisations for their feedback.
All submissions that were not marked as confidential are now available in PDF format.
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- Consultation submission: Biotherapeutics Association of Australasia (pdf,370kb)
- Consultation submission: Johnson & Johnson Pty Ltd (pdf,274kb)
- Consultation submission: Novartis Pharmaceuticals Australia Pty Ltd (pdf,1.28Mb)
- Consultation submission: Pfizer Australia (pdf,591kb)
The TGA is currently considering all submissions that were received as part of this consultation.
The TGA is not able to approximate a timeframe for publication of the outcome of the consultation at this time.
Further information will be provided as it becomes available.
Any questions relating to submissions should be directed to the Risk Management Plan Coordinator by email to firstname.lastname@example.org.