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 ...

It is very important for pharmaceutical companies to plan carefully for all Good Manufacturing Practice (GMP) inspections, as a successful outcome is required for continued operations. Careful ...

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 ...

The health ministry is unlikely to extend the Schedule M deadline for MSME pharma firms beyond December 31, 2025, as it ...

Drug makers in the EU and U.S. may no longer be required to undergo separate GMP inspections by the FDA and the competent authorities in EU member states following an agreement by the EU and U.S.

WUXI, China, Feb. 26, 2025 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), today announced that it has ...

Only about 1,700, or 26 per cent of India’s estimated 6,500 MSME pharmaceutical manufacturers that were required to come up ...