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News & Press: Regulatory Updates

PHSS March 2020 Regulatory Update: Rev 12 of Annex 1; COVID-19; eCTD Specifications

06 March 2020   (0 Comments)
Posted by: Tamsin Marshall
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PHSS Regulatory Update March 2020 available for download for members! Login to view

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

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




  • Second targeted stakeholders' consultation on the revision of Annex 1, on manufacturing of sterile medicinal products
  • New webpage on nitrosamine contamination
  • Coronavirus disease (COVID-19)
  • International collaboration on GMP inspections
  • European authorities working to avoid shortages of medicines due to Brexit – questions and answers
  • Action Plan on ATMPs
  • Guideline on reproductive toxicology: Detection of Toxicity to Reproduction for Human Pharmaceuticals [ICH S5 (R3)]
  • Implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products
  • ICH M9 on biopharmaceutics classification system based biowaivers
  • Quality of medicines questions and answers: Part 1
  • Pre-authorisation guidance
  • Maintaining control: Remote working and QP certification




  • Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed
  • Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry


  • Guidance for TGO 101- Standard for tablets, capsules and pills
  • ISO TC 198 Sterilization of health care products



  • Second joint targeted stakeholders' consultation on the revision of Annex 1, on manufacturing of sterile medicinal products, of the PIC/S – EU GMP Guide
  • Saudi Arabia applies to Join PIC/S



  • PHSS Aseptic Processing Syndicate Workshops
  • PHSS Sterile Product Manufacture Conference

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