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.

October 2020

Europe

  • How incidents with medicines are managed in the EU – a ten-year analysis
  • Big Data - HMA/EMA Big Data Steering Group
  • Q&A: Type II variations -veterinary
  • Q&A: Extension applications
  • Public consultation on the CEP of the future

UK

MHRA

  • EU Exit and Post Transition guidance webinar series
  • Blog - Investigations in the GMDP environment
  • Academia developing medicines for rare diseases to receive free EMA scientific advice
  • MHRA and FDA Joint Paper 'Data Integrity in Global Clinical Trials'

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

October 2020

USA

  • ICH M7 Guideline: assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk- Q&A
  • Control of nitrosamine impurities in human drugs
  • Resuming Normal Drug and Biologics Manufacturing During the COVID-19 Public Health Emergency
  • Draft guidance - Geriatric information in human prescription drug and biological product labeling
  • Health Secretary Azar Asserts Authority Over F.D.A.
  • Failure to respond to an ANDA complete response letter within the regulatory timeframe
  • ANDA Submissions – Amendments and requests for final approval to tentatively approved ANDAS International

Australia

  • New Early Scientific Advice service to support medicine registrations
  • Information for medicine advertisers: Additional allergen warnings effective 1 September 2020
  • Consultation: Compounded medicines and good manufacturing practice (GMP)

PIC/s

  • 2020 PIC/S virtual Seminar

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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