Pharmaceutical Technology REGULATORY SOURCEBOOK MARCH 2021 55
• Human Gene Therapy for Rare Diseases
(PDF)
• INDs for Phase 2 and Phase 3 Studies
Chemistry, Manufacturing, and Controls
Information (PDF)
• Interpreting Sameness of Gene Therapy
Products Under the Orphan Drug
Regulations, Draft Guidance (PDF)
• Long Term Follow-up After Administration
of Human Gene Therapy Products (PDF)
• NDAs: Impurities in Drug Substances (PDF)
• Notifying FDA of a Permanent
Discontinuance or Interruption in
Manufacturing Under Section 506C of the
FD&C Act Guidance for Industry (PDF)
• PAT—A Framework for Innovative
Pharmaceutical Development, Manufacturing,
and Quality Assurance (PDF)
• Postapproval Changes to Drug Substances
Guidance for Industry, Draft Guidance (PDF)
• Process Validation: General Principles and
Practices (PDF)
• Providing Regulatory Submissions for
Medical Devices in Electronic Format -
Submissions Under Section 745A(b) of the
Federal Food, Drug, and Cosmetic Act (PDF)
• Quality Considerations for Continuous
Manufacturing, Draft Guidance (PDF)
• Quality Systems Approach to Pharmaceutical
Current Good Manufacturing Practice
Regulations (PDF)
• Setting Endotoxin Limits During
Development of Investigational Oncology
Drugs and Biological Products Guidance for
Industry (PDF)
• Sterile Drug Products Produced by Aseptic
Processing—Current Good Manufacturing
Practice (PDF)
• Transdermal and Topical Delivery Systems–
Product Development and Quality
Considerations Guidance for Industry, Draft
Guidance (PDF)
European Medicines Agency (EMA)
EMA Biosimilar Medicines
EMA Human Medicines
EMA Marketing Authorization
EMA Medicines Under Evaluation
EMA Post Authorization
EMA Research and Development
EMA Veterinary Medicines
Select EMA Guidance Documents
• Advanced Therapies: GCP requirements
• Advanced Therapies: GLP requirements
• Advanced Therapies: GMP requirements
• Biologicals: Active Substance
• Biologicals: Finished Product
• Good Distribution Practice (GDP)
• Good Laboratory Practice (GLP)
• Good Manufacturing Practice (GMP)
• Biosimilars
• Cell Therapy and Tissue Engineering
• Gene Therapy
• Nanomedicines
• Paediatrics
• Vaccines
• Quality: Active Substance
• Quality: Excipients
• Quality: Impurities
• Quality: Lifecycle Management
• Quality: Manufacturing
• Quality: Packaging
• Quality: Pharmaceutical Development
