GMP Regulatory Newsletter: Summary Scan | Week of 7/29/18

Laws, Regulations, Guidance, and Concept Papers

  • Another collection of FDA User Fee Rates for FY2019 was released (including those for drugs, outsourcing facilities, and biosimilars).
  • EMA published several items including a broad draft guideline that covers gene therapy products and the CAR-T family of products.
  • WHO published 3 guidance for consultation.
  • HPRA, Health Canada, and PIC/S each published 1 item.

To see the complete list of laws, regulations, guidance, and concept papers published this week, start your FREE GMP Regulatory Intelligence Trial today.


  • Picked up this week with 5 warning letters:
    • 1 device
    • 1 compounding pharmacy
    • 3 pharma firms
  • We continue to provide the FDA requested information in our summaries (free consulting for anyone who has similar problems).
  • Several import alerts were put in place for failure to follow drug GMPs, including for one of Hospira’s sites in India with exceptions for ‘necessary’ medicines.


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