US FDA will send ‘cGMP declarations’ to regulatory authorities in other countries where firms want to market drug products made in the US. There is some hope that the declarations will fill in for EU GMP certificates no longer issued for US manufacturing facilities now that there is a US/EU mutual recognition agreement on inspections.
New “cGMP declaration” letters US FDA is offering to send foreign regulatory authorities could solve problems many drug product manufacturers are having now that European authorities aren’t inspecting their US facilities.
Implementation of the March 2017 US/EU mutual recognition agreement designed to reduce duplicative inspections is going well, with the European Medicines Agency removing 60 US inspections from this year’s schedule and 70 from next year’s
MFN policy would would apply to all single source drugs in all insurance markets, according to HHS release. Secretary Robert F. Kennedy Jr. said the department is discussing the plan with drug sponsors.
Spanish authorities say that that timelines for drug reimbursement decisions can be improved further with the right submissions from companies.
Spanish authorities have published more pricing and reimbursement reports as part of a new drive to increase transparency.
