EMA Quality Pharmaceutical Development

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 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

  • 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