Laws, Regulations, Guidance, and Concept Papers

Guidance documents were in modest supply this week:

  • 4 from FDA
  • 4 from EMA
  • 2 from Health Canada
  • 2 items from Pakistan
  • FDA also withdrew 1 final rule due to “significant adverse comments” received during the comment period ending April 11th 2018. This one is important.

In the non-guidance area, we have the usual collection from the US, MHRA, and EMA. The EMA 2017 Annual Report addresses a dramatic decrease in the number of inspections based on the MRA that is now in place with the US. Thus, EMA inspectors have been coming to fewer sites in the US where the FDA routinely inspects.


Enforcement this week was light:

  • 1 letter to a compounding pharmacy
  • Several recalls
  • A few import alerts
  • A form-483 recently issued to Suven Life Sciences Limited
  • Czech authorities issued a report of GDP non-compliance

Seventeen (17) of thirty-seven (37) warning letters have been issued to OTC manufacturers so far this year. This represents 46% of warning letters for the year. OTC manufacturers have replaced the compounding pharmacies in terms of FDA’s warning letter issuance so far.