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.

January 2021

Europe

  • Brexit-related guidance for companies
  • Updated Q&A to Stakeholders on the implementation of the Protocol on Ireland/Northern Ireland
  • Treatments and vaccines for COVID-19
  • Transparency: exceptional measures for COVID-19 medicines
  • Q&A on labelling flexibilities for COVID-19 vaccines
  • ATMP Certification procedures for micro-, small- and medium-sized enterprises (SMEs)
  • Guidance on GMP &GDP – Updated Q&A
  • Product-information templates - Human
  • Excipients labelling
  • Cyberattack on EMA - updates
  • Stability Testing of new veterinary drug substances and medicinal products in climatic zones III and IV
  • EMA Management Board: highlights of December 2020 meeting
  • Ranitidine-containing medicinal products
  • VICH GL59 Harmonisation of criteria to waive laboratory animal batch safety testing for vaccines for veterinary use
  • COVID-19: EDQM business continuity plan to safeguard core activities
  • Updated European Pharmacopoeia vaccines package for COVID-19 vaccine developers
  • Webinar “N-nitrosamine impurities: latest update on the Ph. Eur. approach”
  • BREXIT: impact on ordering and shipment of EDQM products

UK

  • UK-EU trade and cooperation agreement summary / full agreement

MHRA

  • Qualifications of suppliers and customers online: reliable or fake news
  • Pharmacovigilance requirements for UK authorised products from 1 Jan. 2021

February 2021

Europe

  • Ranitidine-containing medicinal products
  • Application of the EU pharmaceutical acquis in markets historically dependent on medicines supply from Great Britain
  • New status of NIBSC (UK) as observer within OCABR network post-Brexit
  • Implementation of the European Pharmacopoeia Supplement 10.5 – Notification for CEP holders
  • CEP holders invited to comment on draft monographs published in Pharmeuropa 33.1
  • New Ph Eur Technical Guide for the elaboration of monographs on medicinal products containing chemically defined active substances
  • Transparency: exceptional measures for COVID-19 medicines
  • Extra dose from vials of Comirnaty COVID-19 vaccine
  • Cyberattack on EMA - updates
  • Medicines for use outside the European Union
  • Overview of comments received on ICH guideline Q3D(R2) on elemental impurities
  • SME Office Newsletter
  • Implementation of the new Veterinary Medicines Regulation

UK

MHRA

  • Guidance for industry and organisations to follow from 1 January 2021.
  • Exporting active substances manufactured in Great Britain for use in EEA and Northern Ireland
  • Blog - Pharmacovigilance requirements for UK authorised products

March 2021

Europe

  • Adapting COVID-19 vaccines to SARS-CoV-2 variants: guidance for vaccine manufacturers
  • Type-1A and IB variations: Q&As
  • Nitrosamine impurities
  • CHMP early contact with patient/ consumer organisations
  • Accelerated assessment
  • Joint Audit Programme

UK MHRA

  • GPvP -latest inspection metrics

Please scroll down for USA and International

January 2021

USA

  • Controlled Correspondence Related to Generic Drug Development
  • Consumer Antiseptic Rub Final Rule Q&A International

Australia

  • Test method: UPLCC01 – Cannabinoids Products
  • UK Regulatory approval of Pfizer/BioNTech vaccine for COVID-19
  • Oxford University/AstraZeneca COVID-19 vaccine approved for use in UK.
  • EMA recommends first COVID-19 vaccine for authorisation in the EU
  • Pfizer-BioNTech COVID-19 Vaccine (USA)
  • Moderna COVID-19 Vaccine (USA)

February 2021

USA

  • COVID-19: Potency assay considerations for monoclonal antibodies and other therapeutic proteins targeting SARS-CoV-2 infectivity
  • Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (COVID-19)

Products

  • Moderna vaccine becomes third COVID-19 vaccine approved by UK regulator
  • EMA recommends COVID-19 Vaccine Moderna for authorisation in the EU
  • EMA recommends COVID-19 Vaccine AstraZeneca for authorisation in the EU
  • EMA Clarification of Comirnaty dosage
  • Australia provisionally approves Pfizer COVID-19 vaccine

March 2021

International

Australia - TGA

  • TGA invited to participate on European committees on COVID-19 vaccines and therapeutics
  • The TGA's risk management approach V 5.0

International Coalition of Medicines Regulatory Authorities (ICMRA)

  • International cooperation to align approaches for regulation of COVID-19 vaccines and medicines

Products

  • EMA starts rolling review of Novavax’s COVID-19 vaccine (NVX-CoV2373)
  • EMA starts rolling review of CureVac’s COVID-19 vaccine (CVnCoV)
  • Clarification on Sputnik V vaccine in the EU approval process
  • Australian TGA provisionally approves AstraZeneca's COVID-19 vaccine
  • Precautionary marketing suspension of thalassaemia medicine Zynteglo
  • EMA issues advice on use of REGN-COV2 antibody combination (casirivimab / imdevimab)
  • Rapid implementation of the revised sartan monographs on 1 April 2021

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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