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News & Press: Regulatory Updates

PHSS Jun 2018 Reg Update: Annex 16 Q&A; Outcome of PIC/S Meetings April 2018

05 June 2018  
Posted by: Tamsin Marshall
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PHSS Regulatory Update June 2018


During the last 4 weeks there have been several developments in the regulation of the pharmaceutical industry. This month reported issues have come from the Australian, EU and  USA regulatory authorities.

The topics covered in this edition of the “Update” include:



  • Annex 16 Q&A - unexpected deviations
  • International collaboration on GMP API inspections
  • EMA 2017 annual report
  • Summary record - technical expert seminar on pharmaceuticals related matters, following UK withdrawal
  • Export manufacturing waiver to Supplementary Protection Certificates
  • Obtaining medicines for wholesale using prescriptions / important update on attempted thefts from warehouses


  • Ombudsman’s 2017 Annual Report FDA – CDER

  •  Facility Definition Under Section 503B of the FD&C Act

  •  Waivers, exceptions, and exemptions from section 582 of the FD&C Act.

  •  FDA video series about biosimilar and interchangeable products

  •  Bioanalytical method validation



  • Half yearly performance snapshot: July to December 2017
  • Biologicals regulatory framework proposed changes
  • Management and Communication of Medicines shortages





  • Medicine Labels: Guidance on TGO 91 and TGO 92
  • Child-resistant packaging requirements for medicines - Guidance on TGO 95


  • Outcome of PIC/S Meetings April 2018

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