50 Pharmaceutical Technology REGULATORY SOURCEBOOK MARCH 2020 P h a r mTe c h . c o m
Resources: Guidelines
• Current Good Manufacturing Practice—Guid-
ance for Human Drug Compounding Outsourc-
ing Facilities Under Section 503B of the FD&C
Act Guidance for Industry, Draft Guidance
(PDF)
• Data Integrity and Compliance With Current
Good Manufacturing Practice Guidance for In-
dustry (PDF)
• Demonstrating Substantial Evidence of Effective-
ness for Human Drug and Biological Products,
Draft Guidance (PDF)
• Elemental Impurities in Drug Products Guidance
for Industry (PDF)
• Harmonizing Compendial Standards With Drug
Application Approval Using the USP Pending
Monograph Process Guidance for Industry, Draft
Guidance (PDF)
• 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 Guid-
ance (PDF)
• Long Term Follow-up After Administration of
Human Gene Therapy Products (PDF)
• NDAs: Impurities in Drug Substances (PDF)
• PAT—A Framework for Innovative Pharmaceuti-
cal Development, Manufacturing, and Quality
Assurance (PDF)
• Postapproval Changes to Drug Substances Guid-
ance for Industry, Draft Guidance (PDF)
• Preparation of Investigational New Drug Products
(Human and Animal) (PDF)
• Process Validation: General Principles and Prac-
tices (PDF)
• Quality Considerations for Continuous Manufac-
turing, Draft Guidance (PDF)
• Quality Systems Approach to Pharmaceutical
Current Good Manufacturing Practice Regula-
tions (PDF)
• Sterile Drug Products Produced by Aseptic Pro-
cessing—Current Good Manufacturing Prac-
tice (PDF)
• Transdermal and Topical Delivery Systems–Prod-
uct 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Guidance for Industry, Draft Guidance (PDF)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
