Laws, Regulations, Guidance, and Concept Papers

It was a light week on the guidance front particularly from the EMA and the FDA. On the other hand:

  • WHO published two drafts.
  • Health Canada published a final revision to their drug GMPs.
  • And, perhaps more important than all (I admit I’m prejudiced on the topic), is the final version of the MHRA GXP Guidance on Data Integrity.

The non-guidance publication was also light this week, but there were contributions from FDA, EMA, MHRA, and CDSCO who published Q&As on their new medical device requirements.


Enforcement information included:

  • Two warning letters to finished pharmaceutical manufacturers, both located outside the US.
  • One letter to a compounding pharmacy.
  • Three warning letters to manufacturers of duodenoscopes (remember them?) for failures in post approval safety reporting.

There were also three forms 483 issued to drug firms and one issued to a device firm. The latter is extensive and focuses on investigation of customer complaints. FDA published recalls in all classes. Hospira also had a yet unclassified recall for cracked or empty vials. Import alerts were put in place for failure to comply with drug GMPs, distributing unapproved drug products in the US, and delaying or impeding an FDA inspection.