The Pharmaceutical Inspection Co-operation Scheme (PIC/S) announced this month that it has adopted new guidance on good manufacturing practice (GMP) inspections, outlining a process for “desk-top ...

The European Union is collaborating with the Pharmaceutical Inspection Co-operation Scheme to develop similar guides for evaluating inspectorates’ competency. The European Union’s medicines agencies, ...

EU and US regulators are striving to work together on improving GMP inspection efficiencies and avoiding duplication of efforts. The European network of medicines regulatory agencies, co-ordinated by ...

Biopharma is a global industry with drug firms routinely supplying medicines to multiple markets from the same manufacturing plant. But while globalization has helped expand revenues, it has also ...

The European Medicines Agency (EMA) this week announced it is waiving fees for on-site good manufacturing practice (GMP) inspections of drugmakers and blood establishments that have undergone remote ...

The agency hopes to better use global resources and avoid duplicate inspections of foreign facilities. The need to inspect a growing volume of overseas pharmaceutical manufacturers, but limited FDA ...

WUXI, China, Oct. 27, 2021 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a global company with leading open-access biologics technology platforms, announced that it has completed a remote GMP ...

PETACH TIKVA, Israel, Sept. 16, 2025 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) ("PolyPid" or the "Company"), a late-stage biopharma company aiming to improve surgical outcomes, today announced ...

WUXI, China, Feb. 27, 2025 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), today announced that it has ...

The Dutch authority carrying out GMP inspections, the Health and Youth Care Inspectorate (IGJ), announced it will carry out a series of pilot inspections focussing on the validation of computerised ...