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News & Press: Regulatory Updates

PHSS May 2020 Reg Update: COVID-19: What's new; Approval of GxP documents WFH; Temporary Policy PPE

05 May 2020  
Posted by: Tamsin Marshall
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PHSS Regulatory Update May 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, USA and UK regulatory authorities. 
[This month we in particular note a number of Risk Based decisions pertinent to the coronavirus (COVID-19) outbreak. MBH]
The topics covered in this edition of the “Update” include:

 

Europe

  • COVID-19: What's new
  • New measures to support availability of medicines used in the COVID-19 pandemic
  • Guidance for medicine developers and companies on COVID-19
  • Updates to GMP and GDP with respect to COVID-19
  • Update to Advanced Therapy Medicinal Products (ATMP): Overview
  • Q&A on regulatory expectations for medicinal products for human use during the COVID-19 pandemic.
  • Compilation of Quality Review of Documentation (QRD) decisions on stylistic matters in product information
  • Reflection paper on GMP and Marketing Authorisation Holders
  • Frequently asked questions about parallel distribution
  • Information note on the format and validity features of electronic certificates for medicines issued by the EMA. 
  • Pharmacovigilance inspection procedures
UK
  • Approval of GxP documents when working from home during the coronavirus (COVID-19) outbreak
  • Process Licensing Update
  • Pharmacovigilance Inspection Metrics Report April 2018 –March 2019 
 
International

USA

  • Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency 
  • Temporary Policy Regarding Non-Standard PPE Practices for Sterile Compounding by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-Public Health Emergency
  • Policy for the Temporary Use of Portable Cryogenic Containers Not in Compliance With 21 CFR 211.94(e)(1) For Oxygen and Nitrogen During the COVID-19 Public Health Emergency.
  • Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency 
  • Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency
  • Temporary Policy on Repackaging or Combining Propofol Drug Products During the COVID-19 Public Health Emergency
 

Australia

Therapeutic Goods Administration (TGA) 

  • Reuse of face masks and gowns during the COVID-19 pandemic
  • Domestic GMP inspections during the COVID-19 pandemic
  • Additional safety protections relating to COVID-19 for faecal microbiota transplant (FMT) products
 

Products

EMA

  • EMA provides recommendations on compassionate use of remdesivir for COVID-19
  • EMA review of Picato concludes medicine’s risks outweigh its benefits

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