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
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- Pre-marketing authorisation
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- Pre-submission
- Data exclusivity/ Generics/ Biosimilars
- Dossier submission requirements
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- Dossier format
- Application and evaluation
- Post-opinion
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- Post-marketing authorisation
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- 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
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- Renewals
- PSURs
- Transfer of marketing authorisation
- Transparency
- Article 61(3) Notifications
- Marketing and cessation notification
- Sunset clause monitoring
- Urgent safety restrictions
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- 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
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Last Updated: 2018-12-11
