Bioequivalence and Bioavailability Forum

Dear Hemant!

❝ Please let me know from where I can get information of RLD for TGA Market??

Contact a pharmacy in Australia and ask?
See also ARGPM Appendix 15: Biopharmaceutic studies (7. Choice of the reference product for bioequivalence of generic medicines):

Where bioequivalence is a requirement, a generic medicine must be shown to be bioequivalent to the corresponding strength of a leading brand (normally the innovator product) as marketed in Australia.
The actual batch of reference product (comparator) used in a bioequivalence study for a generic medicine should normally be obtained in Australia. This is the TGA’s strong preference. However, in certain circumstances, the TGA may accept bioequivalence studies carried out using a batch of reference product obtained from outside Australia, provided the sponsor can support this with compelling evidence that the formulation of the product used is the same as the formulation marketed in Australia.
The sponsor might argue that the overseas-­sourced innovator product is identical to that available in Australia because they are marketed under the same brand name, by the same sponsor, in both countries. However, this argument is not accepted because the TGA is aware that multinational companies sometimes market different formulations of a medicinal product in different countries under the same (or different) brand name.
In the European Union, it is acceptable for an application for registration of a generic product to be based upon a bioequivalence study where the reference product was obtained in another member state. However, member states of the EU are able to share information regarding the formulation and other characteristics of the innovator brands registered in their respective countries, in order to establish unequivocally the identity of reference products from different member states. This is not possible in Australia.
In order to establish that the overseas reference product is identical to the leading Australian brand, a generic sponsor may be able to provide a declaration from the innovator company that it markets the same product (that is, identical in all respects, including formulation and method of manufacture) in both countries. The TGA would refer such a declaration to the local subsidiary if the declaration was not provided by the local subsidiary company or licensee.
Where such a declaration cannot be provided the following requirements must be met, unless otherwise justified. Otherwise, the sponsor should demonstrate equivalence of the generic product to the Australian­-sourced reference product by conducting an appropriate bioequivalence study or studies.

Text in blue is funny. See pp14-16 for required conditions if the reference product is not Australian.