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.

July 2020

Europe

  • European Commission, EMA and FDA agree new priorities to strengthen their collaboration on medicines
  • Exchange of non public information on Health / Medical Products with Health Canada
  • Adoption of a new European Pharmacopoeia (PhEur) general chapter on Multivariate Statistical Process Control
  • The new approach to extraneous agent testing in immunological veterinary medicinal products (IVMPs) in the European Pharmacopoeia
  • COVID-19: What's new
  • EU actions to support availability of medicines during COVID-19 pandemic – update #7
  • Mandate of the European Innovation Network
  • European regulators make recommendations drawing on lessons learnt from presence of nitrosamines in sartan medicines
  • Academia developing medicines for rare diseases to receive free EMA scientific advice

UK

  • MHRA and FDA Joint Paper 'Data Integrity in Global Clinical Trials'

August 2020

Europe

  • Action Plan on ATMPs
  • EDQM Highlights – 2019 annual report
  • EMA finalises opinion on presence of nitrosamines in medicines
  • ICH guideline M7 assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk – Q&A Step 2b
  • Guideline on the quality of water for pharmaceutical use
  • EMA Annual activity report 2019
  • Implementation of the new Veterinary Medicines Regulation
  • European medicines agencies network strategy to 2025
  • Joint Audit Programme for EEA GMP inspectorates
  • MHRA planning for return to on-site Good Practice (GxP) inspections
  • MHRA A Practical example of applying Quality Risk Management in GDP – Transportation Risks

September 2020

European Union

  • New reference standards / replacement batches.
  • Nitrosamines risk assessment: update for CEP holders
  • Nitrosamine impurities in human medicinal products
  • Post-authorisation procedural advice for users of the centralised procedure
  • Public statement on the use of herbal medicinal products containing toxic, unsaturated pyrrolizidine alkaloids (PAs) including recommendations regarding contamination of herbal medicinal products with Pas
  • Big data UK
  • Consultation document: changes to Human Medicine Regulations to support the rollout of COVID-19 vaccines
  • Cross Contamination Control in Shared Facilities and Equipment
Please scroll down for USA and International

July 2020

USA

  • GMP considerations for responding to COVID-19 infection in employees in drug and biological products manufacturing
  • Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency
  • Risk Evaluation and Mitigation Strategies: Modifications and Revisions International

Australia – Therapeutic Goods Administration (TGA)

  • COVID-19 delays to adoption of TGO 91 labels
  • COVID-19 and eligibility to request consent to supply therapeutic goods that do not comply with the new labelling requirements of TGO 92
  • Notice - the implications of adopting the PIC/S Guide to GMP PE009-14
  • Country of origin and medicine quality

China

  • Newly Revised Provisions for the Supervision and Administration of Drug Production

International Coalition of Medicines Regulatory Authorities (ICMRA)

  • Supporting the development of COVID-19 vaccines and treatments

PIC/s

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

Products

  • The value of safe and effective vaccines
  • Levothyroxine product - specific bioequivalence guidance (EU)

Documents

  • From laboratory to patient: the journey of a medicine assessed by EMA

August 2020

USA

  • FDA prepares for resumption of domestic inspections with new risk assessment system
  • Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products
  • Setting endotoxin limits during development of investigational oncology drugs and biological products

International

Australia

  • GMP approach to overseas manufacturers of medicines and biologicals during the COVID-19 pandemic
  • TGA expectations for overseas manufacturing sites hosting remote inspections during the COVID-19 pandemic
  • Consultation on the new Therapeutic Goods Order 106 - Data matrix codes and serialisation of medicines

Products

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

September 2020

USA

  • Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency - Q&A.
  • Compliance policy for the quantity of bioavailability and bioequivalence samples retained under 21 CFR 320.38(c)
  • Marketing status notifications under section 506i of the Federal Food, Drug, and Cosmetic Act (FD&C act)

International

Australia – Therapeutic Goods Administration (TGA)

  • TGA business plan 2020/2021
  • Disinfectants: FAQ for new sponsors
  • Faecal microbiota transplant (FMT) products regulation

PIC/s

  • Azerbaijan applies for pre-accession

Products

  • Ranitidine containing products
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

image
image
image

Contact information PHSS

6a Kingsdown Orchard, Hyde Road

Swindon, Wiltshire

SN2 7RR UK

W: www.phss.co.uk

E: info@phss.co.uk

T: +44 (0) 1793 824254