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

November 2020

Europe

  • Nitrosamine impurities – update
  • ICH guideline M7 Q&A - comments received
  • IRIS Guide -create and submit scientific applications, for industry and individual applicants
  • Qualification of novel methodologies for drug development: guidance to applicants
  • Veterinary pre-submission Q&A: 21-40
  • ICH guideline Q3D (R2) on elemental impuritiesStep 2b
  • EU Big Data Stakeholder Virtual Forum
  • EMA encourages companies to submit type I variations for 2020 by end of November
  • Launch of public consultation on the CEP of the future
  • New general text on implementation of pharmacopoeial procedures
  • Friability of uncoated tablets

UK

MHRA

  • New Rules from January 2021

December 2020

Europe

  • HMA/EMA statement on approval of vaccines
  • Continuation of COVID-19 vaccine trials for longer-term safety and efficacy follow-up
  • EMA organises public meeting on COVID-19 vaccines
  • Q&A on labelling flexibilities for COVID-19 vaccines
  • Workshop on regulatory support for development of orphan medicines
  • Frequently asked questions about parallel distribution
  • Brexit-related guidance for companies
  • Notification on arrangements for requesting EMA certificates through urgent and standard procedure for December 2020

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)

November 2020

USA

  • The use of physiologically based pharmacokinetic analyses — biopharmaceutics applications for oral drug product development, manufacturing changes, and controls
  • Annual status report information and other submissions for postmarketing requirements and commitments: using forms FDA 3988 and FDA 3989 Guidance for Industry
  • Referencing Approved Drug Products in ANDA Submissions
  • Wholesale distributor verification requirement for saleable returned drug product and dispenser verification requirements when investigating a suspect or illegitimate product

International

PIC/s

  • PIC/S Seminar 2020
  • PIC/S Expert Circle on Quality Risk Management (QRM) webinar

December 2020

USA

  • Cross Labeling Oncology Drugs in Combination Regimens Guidance for Industry
  • Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act
  • Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA Guidance for Industry

International

Australia - TGA

  • COVID-19 vaccine provisional determinations
  • Manufacturing Quality Branch annual reports

PIC/s

  • Brazil / ANVISA joins PIC/S

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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