The revised guidelines for making submissions to list drugs on the Australian Pharmaceutical Benefits Scheme have raised industry and patient concerns over the criteria for choosing the comparator drug, how to assess differing levels of evidence, and the need for more patient and clinician input.
The review of the Australian guidelines on submitting medicines for inclusion on the Pharmaceutical Benefits Scheme is expected to be completed in November, after which a set of workshops will be held to help companies planning to file drugs for reimbursement under the new guidance, according to the Department of Health.
The review, which began in April 2015, is intended to ensure assessment processes at the Pharmaceutical Benefits Advisory Committee are...
Data is “the new oil,” but its use will challenge regulators, while inertia is the biggest disrupter of all for European regulators, according to European Medicines Agency chiefs past and present.
Pharma firms are being encouraged to respond to a European Commission consultation on planned updates to its good manufacturing practice standards which reflect the “rapid advancement” of modern technologies, like AI and digital systems, in drug manufacturing.
China has announced a raft of new measures to encourage innovative drug development across the product life cycle, including using insurance data to differentiate new therapies and applying commercial insurance to selected novel products.
