EMA Quality Pharmaceutical Development

 European Medicines Agency and EMA Guidelines

Guidelines

  • Search for scientific guidelines
  • Quality guidelines
  • Quality of medicines questions and answers: Introduction
  • Biological guidelines
  • Non-clinical guidelines
  • Clinical efficacy and safety guidelines
  • Multidisciplinary guidelines
  • International Conference on Harmonisation (ICH) guidelines

Quality Guidelines (QG)

QGs are for the following:

  • Active substance, manufacturing, impurities, specifications, analytical procedures and analytical validation, excipients, packaging, stability, pharmaceutical development, specific types of products, post-approval change management protocols, herbal medicinal products.

General regulatory and procedural guidance

  • Pre-marketing authorisation
  • Pre-submission
  • Data exclusivity/ Generics/ Biosimilars
  • Dossier submission requirements
  • Dossier format
  • Application and evaluation
  • Post-opinion
  • Post-marketing authorisation
  • General
  • Dossier submission requirements
  • Type IA variations
  • Type IB variations
  • Type II variations
  • Type II variations vs Extension applications
  • Changing the (invented) name of a centrally authorised medicinal product
  • Annual re-assessment
  • Follow-up Measures / Specific Obligations
  • Renewals
  • PSURs
  • Transfer of marketing authorisation
  • Transparency
  • Article 61(3) Notifications
  • Marketing and cessation notification
  • Sunset clause monitoring
  • Urgent safety restrictions
  • Product information
  • Scientific advice and protocol assistance
  • Innovation Task Force (ITF)
  • Small and Medium-sized Enterprises (SME)
  • Paediatrics
  • Orphans
  • Herbal medicinal products
  • Referral procedures
  • Article 58 applications
  • Pharmacovigilance
  • Advanced therapies
  • Inspections
  • Parallel distribution
  • Ancillary medicinal substances
  • New countries/EFTA

Last Updated: 2018-12-11