Laws, Regulations, Guidance, and Concept Papers

A lite week for new guidance publications: 2 each from FDA and EMA.

Among the non-guidance publications are 2 of particular interest:

  • 1st is a report of the drug approval times in the major health authority jurisdictions (including some nice graphs and figures) published by The Centre for Innovation in Regulatory Science.
  • The 2nd is an FDA report on difficulties in reporting done by IQVIA regarding distribution of some controlled substances.
  • Data integrity is important everywhere.
  • Others are from FDA, EMA, MHRA, and HPRA.


Enforcement saw only:

  • 2 warning letters to drug manufacturers this week out of a total of 4 that were posted.
  • 1 European report of non-compliance for GDP deficiencies was made available.
  • Recalls identified only 3 firms.
  • Kroger Specialty Pharmacies recalled a total of approximately 67 products this week.
  • 3 unclassified recalls were announced.
  • 2 import alerts in the categories we follow.