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 2020

Europe

  • EMA Management Board: highlights of December 2019 meeting
  • Updated Q&A on “Information on nitrosamines for marketing authorisation holders”
  • Availability / shortages of medicines
  • International collaboration on GMP inspections – manufacturers of sterile medicines
  • Post-authorisation procedural advice for users of the centralised procedure
  • Q&A on comparability considerations for advanced therapy medicinal products (ATMP)
  • FAQ about parallel distribution
  • European Paediatric Formulary online
  • Pharmeuropa 32.1

February 2020

Europe

  • UK withdrawal from the EU on 31 January 2020
  • European authorities working to avoid shortages of medicines due to Brexit – updated Q&A
  • Ten recommendations to unlock the potential of big data for public health in the EU
  • Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders
  • Electronic product information for human medicines in the EU:key principles
  • Court of Justice upholds EMA’s approach to transparency
  • Substances considered as not falling within the scope of Regulation (EC) No. 470/20091, with regard to residues of veterinary medicinal products in foodstuffs of animal origin
  • Q&A on impact of EU-USA MRA on marketing authorisation applications and relevant variations
  • EDQM launches new Pharmeuropa website

March 2020

Europe

  • Second targeted stakeholders' consultation on the revision of Annex 1, on manufacturing of sterile medicinal products
  • New webpage on nitrosamine contamination
  • Coronavirus disease (COVID-19)
  • International collaboration on GMP inspections
  • European authorities working to avoid shortages of medicines due to Brexit – questions and answers
  • Action Plan on ATMPs
  • Guideline on reproductive toxicology: Detection of Toxicity to Reproduction for Human Pharmaceuticals [ICH S5 (R3)]
  • Implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products
  • ICH M9 on biopharmaceutics classification system based biowaivers
  • Quality of medicines questions and answers: Part 1
  • Pre-authorisation guidance
  • Maintaining control: Remote working and QP certification
Please scroll down for USA and International

January 2020

International

Australia

  • Reforms to the generic medicine market authorisation process: implementation update
  • Uniform recall procedure for therapeutic goods (URPTG)
  • Medicinal cannabis manufacture
  • Export of therapeutic goods from Australia

PIC/s

  • Draft PIC/S Recommendation on How to Evaluate / Demonstrate the Effectiveness of a Pharmaceutical Quality System in relation to Risk-based Change Management
  • PIC/S events in Toyama, Japan, 11-15 November 2019

Products

  • Estradiol-containing (0.01% w/w) medicinal products for topical use
  • EMA & TGA update on metformin diabetes medicines

February 2020

USA

  • CMC information for human gene therapy INDs
  • FDA Continues Strong Support of Innovation in Development of Gene Therapy Products
  • Applications Affected by the Reorganization of the Office of New Drugs

International

Products

  • First oral GLP-1 treatment for type 2 diabetes

Conferences

  • MHRA Laboratories Practice Symposium
  • PHSS Aseptic Processing Syndicate Workshop

March 2020

USA

  • Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed
  • Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry

International

Australia – Therapeutic Goods Administration (TGA)

  • Guidance for TGO 101- Standard for tablets, capsules and pills
  • ISO TC 198 Sterilization of health care products

PIC/s

  • Second joint targeted stakeholders' consultation on the revision of Annex 1, on manufacturing of sterile medicinal products, of the PIC/S – EU GMP Guide
  • Saudi Arabia applies to Join 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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