Kenny Banya
Senior Member
- Messages
- 356
- Location
- Australia
I have had advice from a knowledgeable person in drug trials at Melbourne University's medical science faculty, that if the Norwegian trials are registered with the European Medicines Agency, that will be a sufficient reference point to instigate its application for listing on the Pharmaceutical Benefits Scheme via the Therapeutic Goods Administration. We tend to piggyback off the listings in Europe & America, as we don't have the same population & funding to 'go it alone'.
Unless someone with insight can advise, I am going to contact the relevant parties in Norway to confirm it will be registered, once results are known.
I was advised that we only undertake Phase III trials of new drugs, such as the biosimilar Truxima, or existing drugs for new indications, when there aren't identical trials being conducted in other countries. Obviously cost is the major factor.
Unless someone with insight can advise, I am going to contact the relevant parties in Norway to confirm it will be registered, once results are known.
I was advised that we only undertake Phase III trials of new drugs, such as the biosimilar Truxima, or existing drugs for new indications, when there aren't identical trials being conducted in other countries. Obviously cost is the major factor.