Posted by Michael Wonder on 18 Sep 2018
Changes to TGA/PBAC parallel processing arrangements for biosimilar medicines
18 September 2018 - Submissions requesting the listing of a new biosimilar medicine are no longer eligible to be submitted under the TGA/PBAC parallel processing arrangements.
These arrangements take effect from the November major submission deadline.
Updated TGA/PBAC parallel process guidance and procedures guidance are now available.
