Regulatory update

Welcome to this quarter's Regulatory Update compiled by Malcolm Holmes.


Each column has the monthly highlight for Europe in the first section and USA & International are accessed by scrolling further down the page


Should you wish to receive a full copy supplied with hyperlinks then please go to the PHSS Website and join as a member.

April 2020

Europe

  • Coronavirus disease (COVID-19)
  • EMA to issue electronic certificates for medicines
  • Qualification of novel methodologies for medicine development
  • Nitrosamine impurities
  • EMA to review ranitidine medicines following detection of NDMA
  • EMA Management Board March 2020
  • Brexit-related guidance for companies
  • EMA publishes ICH guideline Q12
  • Veterinary post-authorisation Q&A
  • Update on the European Pharmacopoeia (PhEur) policy on elemental impurities – Excipients of natural origin
  • Tetanus vaccines – Rationalising toxicity testing requirements
  • Deadline extension to all CEP holders to complete step 1 Risk Assessments regarding presence of nitrosamines
  • MHRA Good Practice (GxP) inspections during the COVID19 outbreak
  • MHRA Coronavirus guidance
  • Advice for Management of Clinical trials in relation to Coronavirus
  • Guidance for Good Laboratory Practice (GLP) facilities in relation to coronavirus (COVID-19)
  • Veterinary post-authorisation Q&A

May 2020

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

June 2020

European Union

  • COVID-19: What's new
  • EU actions to support availability of medicines during COVID-19 pandemic – update #5
  • Decision on fee reductions (GMP) on-site inspections due to COVID-19 pandemic
  • Q&A- regulatory expectations for medicinal products for human use during the COVID-19 Pandemic (rev 1)
  • Deadline postponed for the second targeted consultation on Annex 1
  • Post-authorisation measures: Q&A
  • Risk management plan (RMP): Q&A
  • Transfer of marketing authorisation: Q&A
  • Renewal and annual re-assessment of marketing authorisation
  • Checklist for Initial Notifications for Parallel
  • Distribution
  • Minutes of the 107th meeting of the EMA Management Board UK MHRA
  • How to manage temporary GDP process changes and risks through the COVID-19 pandemic
Please scroll down for USA and International

April 2020

USA

  • The “Deemed To Be a License” provision of the BPCI Act Q&A
  • Safety Testing of Drug Metabolites
  • Q3D(R1) Elemental Impurities
  • Competitive Generic Therapies
  • Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)
  • Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)

International

Australia – Therapeutic Goods Administration (TGA)

  • Physical samples for batch release not required: a reminder for sponsors of biosimilars and biological medicines
  • TGA suspends overseas GMP inspections and QMS audits

TGA to expand quality audits for medicinal cannabis

Products

  • Kromeya - Withdrawal of the marketing authorisation in the EU

May 2020

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-19 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

International

Australia

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

June 2020

USA

  • General considerations for pre-IND meeting requests for COVID-19 related drugs and biological products
  • Recommendations for the permitted daily exposures for three solvents—2-methyltetrahydrofuran,cyclopentyl methyl ether, and tert-butyl alcohol—according to the maintenance procedures for the guidance Q3C (R8)impurities:residual solvents
  • Orange Book Q&A Guidance for Industry (draft)

International

Australia – Therapeutic Goods Administration (TGA)

  • Update to Manufacturing Principles for medicines, APIs & sunscreens
  • Reuse of face masks and gowns during the COVID-19 pandemic

China

  • National Medical Products Newsletter 2020 Volume 3

PIC/s

  • Adoption and Entry into Force of New PIC/S Guidance Documents (PI 052-1 and PI 053-1)

Products

  • New vaccine for prevention of Ebola virus disease recommended for approval in the EU
Further information on these and other topics can be found in recent versions of the “Regulatory Update” on the PHSS website and on the websites of the relevant regulatory bodies and international organisations. We hope that our readers find our reviews to be both informative and helpful in keeping up to date with pharmaceutical legislation and regulatory guidance.

GMP Update is compiled by Malcolm Holmes an independent GMP consultant and member of the PHSS Management Committee

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