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


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July 2019

Europe

  • EMA activities, other than the highest priority activities, that will continue in 2019
  • Variations to Marketing Authorisations
  • BREXIT
  • EU-US mutual recognition agreement for inspections
  • Temporary interim limits for NMBA, DIPNA and EIPNA impurities in sartan blood pressure medicines
  • How to prepare and review a summary of product characteristics
  • Quality requirements for drug-device combinations
  • Q&A on the use of OOS batches of authorised cell/tissue-based ATMPs
  • MHRA The 2018 Good Distribution Practice (GDP) and GMP Symposia


August 2019

Europe

  • EU / US MRA fully operational
  • Medicine shortages: EU network takes steps to improve reporting and communication
  • Call for all sponsors to publish clinical trial results in EU database
  • EMA takes note of the European Ombudsman’s decision on pre-submission activities
  • MHRA Blog - How the implementation of Safety Features progresses 5 months in
  • UK government - Development of new antibiotics encouraged with new pharmaceutical payment system
  • BP and USP formalize partnership to strengthen quality of medicines and public health

September 2019

Europe

  • Q&A on the exemption from batch controls carried out on ATMPs imported into the European Union from a third country.
  • Sartan medicines: companies to review manufacturing processes to avoid presence of nitrosamine impurities
  • Temporary interim limits for NMBA, DIPNA and EIPNA impurities in sartan blood pressure medicines
  • EMA/FDA analysis shows high degree of alignment in marketing application decisions between EU and USA
  • MHRA Falsified Medicines and the supply chain (part 2)
  • MHRA Analytical Quality by Design (AQbD): Q&A

Please scroll down for USA and International

July 2019

USA

  • Formal Dispute Resolution: sponsor appeals above the division level
  • ANDA Submissions — content and format of abbreviated new drug applications
  • Providing regulatory submissions in electronic and non-electronic format — promotional labeling and advertising materials for human prescription drugs
  • Opioid Analgesic Drugs: considerations
  • for benefit-risk assessment framework
  • guidance for industry
  • Modernizing FDA's New Drugs Regulatory Program
  • CDER Conversation: Ensuring that standardization does not impede biological product innovation
  • FDA poliovirus assay is faster and more versatile than current assays
  • Additional safety protections regarding use of fecal microbiota for transplantation
  • Guidance Documents CBER is Planning to Publish During Calendar Year 2019
  • Bioanalytical method validation M10
  • CBER Advanced Technologies Program

International

Australia

  • Excluded autologous human cells and tissues
  • GMP clearance guidance update (v.18.3)

Products

  • Premier Pharmacy Labs issues voluntary nationwide recall of all unexpired sterile drug product lots due to lack of sterility assurance

August 2019

USA

  • CDER office of compliance Annual report FY 2018
  • Instructions for use — content and format
  • Drug Abuse and Dependence section of labeling for human prescription drug and biological products
  • REMS Modifications and revisions guidance for industry
  • Using the Inactive Ingredient Database
  • Cell analysis technique identifies subpopulations of stimulated mesenchymal stromal cells with in vitro immunosuppressive activity
  • Harmonizing compendial standards with drug application approval using the USP pending monograph process guidance for industry

International

Australia

  • TGA strengthens regulation of stem cell treatments
  • Remaking Therapeutic Goods Order No. 78 – (tablets /capsules/pills)

Products

  • Rituzena Withdrawal of the marketing authorisation in the European Union

September 2019

USA

  • HHS announces new action plan to lay foundation for safe importation of certain prescription drugs
  • Child-Resistant Packaging statements in drug product labeling
  • Information about immune globulin (human) product shortage
  • Regulatory harmonization and convergence
  • Biological Product and HCT/P deviation reports annual summary for fiscal year 2018
  • Oncology therapeutic radiopharmaceuticals: nonclinical studies and labeling recommendations
  • Patent certifications and suitability petitions (ANDAs)

International

Australia

  • TGA actions following 2018 stakeholder surveys
  • Mandatory information required in advertising for therapeutic goods

Switzerland

  • Swissmedic laboratory publishes updated test method for nitrosamines in sartans

Products

  • Names of liposomal medicines to be changed to avoid medication errors

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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