The Therapeutic Goods Administration wants to know whether, and how, it should disclose the fact that a medicine has been accepted for regulatory review. It has put several options to stakeholders, including disclosure for all medicines or only certain kinds, or keeping the current practice of “neither confirm nor deny.”

Health Canada is making its decision-making process in the pre-market phase more transparent by disclosing a wider range of information on new and generic drug applications accepted for review.

The UK’s deployment of COVID-19 vaccines has left vaccine manufacturers worried about emerging discussions on dosing strategies that may not be supported by authorized labeling or published clinical data.