The TGA has implemented a Data Protection Scheme for Assessed listed medicines. This Scheme was developed in response to Recommendation 50 of the Medicines and Medical Devices Regulation (MMDR) review and is enabled under section 26AF of the Therapeutic Goods Act 1989.
The purpose of the Scheme is to:
- Incentivise innovation by protecting the results of investment in the development of new works and technology.
- Prevent competitors seeking market authorisation of generic forms of an L(A) medicine by preventing competitors from relying on clinical trials that were generated and used by the sponsor of the originator medicine to obtain market authorisation.
- Encourage further research and development activities by preventing others from capitalising on a sponsor's investment and innovation.
Guidance document
This guidance describes:
- How the Data Protection Scheme for assessed listed medicines works
- How to submit an application and make a restricted information certification
List of assessed listed medicines with data protection
There is no information for inclusion in this table. The text is an example of what information might be added in these fields
| Medicine Name and AUST L(A) | Active Ingredient(s) | New intermediate indication | Unique Clinical Trial number/UTN | Journal article | Protection expiry |
|---|---|---|---|---|---|
Medicine Name AUST L(A) xxxxxx | AAN of active ingredient | Novel intermediate indication | CTN: ACTRN12345678901234 UTN: U1234-5678-9012 | N/A if not published or Clinical study report ABC012021: Evaluation of the efficacy of X (containing 20mg Z) for alleviation of Y. Author. | DD/MM/YYYY+5 |