Industries: Pharma / Biotech

EU Quality Dossier Submission Requirements

Course Director: Mary Rafter

Course Description - Course runs 9:00 to 5:00 both days (Breakfast & Lunch Included)

This course will provide participants with an appreciation of the key quality considerations for EU regulatory dossier submissions for marketing approval, with an emphasis on elements where specific European requirements additional to ICH guidelines must be factored into the Common Technical Document (CTD).  EU guidelines impacting drug substance and starting materials, as well as the use of the CEP (Certificate of Suitability) and ASMF (Active Substance Master file) filing routes will be covered, along with quality requirements applicable to specific types of drug product filing.

Challenges presented to the global dossier by key differences between EU and US regional quality/CMC requirements in the CTD, as well as through EU product information and labelling requirements will be analysed in detail.  Other specific types of regulatory interactions involving quality submissions (e.g. method of sale ‘switching’, batch specific requests, QP Declarations) will be discussed also.

Who Should Attend

An experienced ex-European regulator will deliver this course, which will be of value to personnel in the pharmaceutical and generic drug industries, both to those involved directly in preparing the quality/chemistry, manufacturing and controls (CMC) sections of the marketing authorisation application, as well as those who need an awareness of broader EU quality requirements to ensure these are addressed at all stages of the drug development process.

The course will benefit in particular those engaged in the following disciplines:

  • Regulatory submissions
  • Quality assurance
  • Analytical control
  •  Research &  development
  • Manufacturing
  • Project Managers requiring a knowledge of EU authority submission expectation

Note that the course covers the requirements for synthetic small molecules and does not address biologic

First Day

EU Framework for Quality standards and Harmonization initiatives

  • EU/EEA harmonized framework
  • ICH guideline implementation
  • Pharmacopoeial harmonisation
  • EU External Co-operation agreements for medicines
    • International, Bilateral, Regional

EU Quality submission Requirements impacting Drug Substance

  • Module 3.2.S and ICH requirements (Q11)  revisited
  • Filing drug substance data via CEPs
  • Filing drug substance data via ASMF (EDMF)
  • European Pharmacopoeia general monographs and chapters
  • EMA/CHMP/QWP guidelines impacting drug substance, incl.
    • Chemistry, Chiral active substances, Limits of genotoxic impurities, Residual solvents Annexes, Stability testing
    • Justification of starting materials,  New Active substance status,  Co-crystals reflection papers and revisions

Excipients in European Quality Submissions

  • Ph. Eur. – Substances for Pharmaceutical Use requirements
  • EU Guideline on Excipients in the dossier
  • EC guideline on Excipients in the Label and Leaflet
  • Excipients – TSE requirements  Colorants approved

Second Day

EU Quality requirements impacting Drug Product (3.2.P) filings

  • Pharmaceutical development – EU annexes to ICH Q8 (R2), pediatric formulation
  • Bioequivalence
  • Manufacturing and Process validation guidances
  • Impurities – PH. EUR. monograph impacts, EU annexes to ICH Q3C residual solvents, genotoxic impurities
  • Technical requirements of Annex 1 to Directive 2001/83/EC
  • Packaging materials
  • Stability – EU adopted guidelines impacting Declaration of Storage conditions, In-use stability testing, Maximum shelf life for sterile products after first opening or reconstitution
  • Quality of Oral modified release products, Transdermal patches

EU Module 1 CTD Regional requirements

  • GMP status demonstration and QP Declarations
  • TSE declarations
  • EU Product Information
    • Summary of Products Characteristics, Package leaflet, Labels
    • Readability requirements
    • User testing
  • EU Packaging Information
  • National Agency guidances and interactions

EU switch in Classification for supply of medicines

  • Classification of medicines (Prescription-only, OTC, General Sale)
  • Overview of EU Advertising & Promotion rules
  • EU "Switching" Approach
  • Supporting Data package considerations

Common Application deficiencies

This session will review the most common application deficiencies identified during assessment of quality submissions, from an ex-regulator's perspective as well as from published data, with a view to helping reduce the number of CMC deficiency queries received.

Learning Objectives

At the end of the two-day course attendees will:

  • Understand both the scope and the limitations of harmonization of quality requirements for submission in marketing authorization applications (MAA) to European authorities
  • Appreciate how European quality guidelines impact the filing of the quality/CMC information in the EU Notice to applicants, Volume 2B incorporating the Common Technical document (CTD), for drug substance, starting materials and drug products
  • Learn how the EDQM Certificate of Suitability (CEP) is used for filing drug substance data, as well as requirements of the European Drug Master File (EDMF) procedure
  • Gain an understanding of EU regional requirements as set out in EU Module 1 Administrative Information (e.g. documenting acceptable GMP status, QP Declarations etc.) and Prescribing Information (SPC, Labeling and Package Leaflet, Readability)
  • Have an appreciation of the similarities and differences between EU and US approaches for specific types of quality submissions (e.g. requirements with regard to excipients, starting materials of human or animal origin, chosen reference products for comparability demonstration for generics/hybrids, switching of products from prescription to non-prescription, etc)
  • Gain insight into how to avoid the most common deficiencies encountered in quality submissions


"I found the course to be informative, stimulating, and very timely for increasing understanding of the current Quality Requirements., The instructor was very interactive and made the course content valuable and practical for immediate application to current regulatory activities. I highly recommend this course to anyone needing a background on the subject from a true subject-matter expert." Elaine A. , Program Manager, The Evanston Group