The two regulatory agencies have confirmed the addition of the last country to their mutual recognition agreement, with GMP inspections by Slovakia given a positive assessment.
The EMA looks to the future by posting its five key priorities to address in the coming five years, which includes the need to recruit expertise in ‘novel manufacturing technologies’.
With Germany’s addition to the US FDA-EMA mutual recognition agreement, only Slovakia is left to be added to the agreement, with the deadline later this month.
The EMA’s investigation into ‘sartan’ medicines has concluded, requiring companies to review processing procedures and prove products are without impurities.
Novartis joined industry associations in expressing concerns over the impact that a ‘hard’ or ‘disorderly’ Brexit could have on the life sciences sector.
The EMA announces further details on its move from current London headquarters to Amsterdam, which will begin on March 1 and see staff working in its new offices on March 11.
MedPharm expands its US Center of Excellence in Durham, North Carolina, in response to increasing demand for its topical and transdermal formulation development, and performance testing services.
