Monthly Archives: December 2019


WEEKLY SCAN | December 1, 2019

After a couple of busy weeks, this is a slow one for both guidance publications and enforcement.  The most interesting guidance is one from EMA on GCPs for Advanced Therapy Medicinal Products.  ICH also published ICHQ12, and PIC/S published guidance on evaluating a Pharmaceutical Quality System with regard to risk-based change management. And in the non-guidance section, WHO is [...]

By |2019-12-10T14:30:16+00:00December 10th, 2019|Weekly Scans|

MONTHLY SCAN | November, 2019

Happy Reading, Barbara FDA: DEVICES: The FR announced the availability of final guidance published ‘Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices’ .  The intent of the guidance is to provide transparency on the decision-making process for denial of a certificate and identifies how to request a review of the [...]

By |2019-12-05T15:38:04+00:00December 5th, 2019|Monthly Scans|

WEEKLY SCAN | November 24, 2019

Just a few new guidance documents, one from EMA and three from the FDA.  Probably the most interesting is the one addressing immunogenicity for biosimilar and interchangeable insulin products. On the enforcement front, EDQM has been exceptionally active in posting inspections for GMP non-compliance identified during recent inspections, perhaps reflecting the completion of the EMA move from London to [...]

By |2019-12-03T13:09:50+00:00December 3rd, 2019|Weekly Scans|