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 2019

Europe

  • Ranitidine containing medicinal products
  • Advice to companies on steps to take to avoid nitrosamines in human medicines
  • Change of name of liposomal medicines at high risk of medication errors (update)
  • Implementation of the new Veterinary Medicines Regulation
  • MHRA Blog - Supply chain security: part 1 - introduction

November 2019

Europe

  • New Guide to the quality and safety of tissues and cells for human application
  • EMA encourages companies to submit type I variations for 2019 by end of November 2019
  • European countries increase commitment to responsible antibiotic use in animals
  • EMA Management Board: highlights of October 2019 meeting
  • Dialogue with Chinese authorities on medicine regulation
  • How to ensure that novel analytic methods are fit for decision-making
  • MHRA Process Licensing: useful information
  • MHRA - Digital Health and Pharma 4.0

December 2019

Europe

  • New approach to extraneous agents testing of immunological veterinary medicinal products (IVMPs)
  • Pharmeuropa 31.4 released
  • Updated Q&A on “Information on nitrosamines for marketing authorisation holders”
  • ‘Regulatory science to 2025’: live broadcast of post-consultation workshop
  • Tripartite meeting held to discuss regulatory approaches for the evaluation of antibacterial agents
  • Regulators' Advice Can Make a Difference: European Medicines Agency Approval of Zynteglo for Beta Thalassemia
  • Dutch Authorities hand over final building to EMA in Amsterdam
  • EMA Mid-year report 2019
  • HMA/ EMA task force on Big Data
Please scroll down for USA and International

October 2019

USA

  • NMDA impurity in certain ranitidine products
  • Wholesale distributor verification requirement for saleable returned drug product
  • Bringing remaining approved OTC medically important antimicrobial drugs used for animals under veterinary oversight
  • Reorganization of the Office of New Drugs with Corresponding Changes to the Office of Translational Sciences and the Office of Pharmaceutical Quality
  • TCPro simulates immune system response to biotherapeutic drugs
  • Evaluation of Internal Standard Responses during Chromatographic Bioanalysis: Q&A

International

Australia

  • Updated Guidelines for making an offer of enforceable undertaking to the TGA
  • TGA business plan 2019-20

PIC/s

  • Focused stakeholders consultation on revised draft PIC/S GMP Guide Annex 2A (Manufacture of Advanced Therapy Medicinal Products for Human Use) and Annex 2B (Manufacture of Biological Medicinal Substances and Products for Human Use)

WHO

  • Proposal to discontinue the test for undue toxicity (chapter 3.7) in the international pharmacopeia

Products

  • USFDA approves first live, non-replicating vaccine to prevent smallpox & monkeypox

November 2019

USA

  • Clinical immunogenicity considerations for biosimilar and interchangeable insulin products
  • Transdermal and topical delivery systems - product development and quality considerations

International

Australia – Therapeutic Goods Administration (TGA)

  • Safety review of coumarin in topical listed medicines
  • Consultation: Draft standards for faecal microbiota transplant (FMT) products

December 2019

USA

  • Clinical immunogenicity considerations for biosimilar and interchangeable insulin products
  • Transdermal and topical delivery systems - product development and quality considerations


International

Australia – Therapeutic Goods Administration (TGA)

  • Safety review of coumarin in topical listed medicines
  • Consultation: Draft standards for faecal microbiota transplant (FMT) 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