US FDA has no plans to acquire GMP certificates from other PIC/S members
This article was originally published in SRA
Two months after joining the international Pharmaceutical Inspection Convention and Co-operation Scheme, the US Food and Drug Administration has confirmed that it "does not intend at this time to acquire GMP [good manufacturing practice] certificates from other PIC/S members"1.
You may also be interested in...
The European Directorate for the Quality of Medicines & HealthCare is proceeding carefully to find the right balance between serving the diverse requirements of various stakeholders that make use of its ‘certificates of suitability.’
The International Pharmaceutical Regulators Programme has documented various approaches currently being used for the clinical comparability of biosimilar monoclonal antibodies in different jurisdictions.
Remote inspections are here to stay, and global regulators are aligning efforts to develop consensus on how these should be conducted.