Guidance on orphan drug designation has been published as part of an ongoing initiative to provide our stakeholders with a clear understanding of Australia's regulatory requirements for therapeutic goods.
This was progressed as part of the TGA reforms: A Blueprint for TGA's future.
The Blueprint aims to improve the Australian community's understanding of our regulatory processes and decisions, and to enhance public trust in the safety and quality of therapeutic goods. As part of this, we are working to ensure that the regulatory guidance available to potential applicants is accessible, comprehensive, easily understood, and available in different formats to meet their needs.
'Orphan drugs' are often developed to treat small and very specific patient populations who suffer from rare diseases and conditions.
The application and evaluation fees for orphan drugs can be waived to:
- help reduce their development costs
- facilitate their access to the Australian marketplace
However, a medicine needs to be:
- designated by us as an orphan drug before an application can be accepted to register it on the Australian Register of Therapeutic Goods (ARTG)
- evaluated for quality, safety and efficacy in the same way as other registered medicines.
GUIDELINES AVAILABLE CLICK HERE
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