www.biopharminternational.com December 2019 BioPharm International eBook 43
Regulatory Sourcebook Resources
EUROPEAN MEDICINES
AGENCY (EMA) RESOURCES
• EMA Biosimilar Medicines
• EMA Human Medicines
• EMA Marketing Authorization
• EMA Medicines Under Evaluation
• EMA Post Authorization
• EMA Research and Development
• EMA Veterinary Medicines
EMA GUIDANCE
DOCUMENTS
• Advanced Therapies:
GCP requirements
• Advanced Therapies:
GLP requirements
• Advanced Therapies:
GMP Requirements
• Biologicals: Active Substance
• Biologicals: Finished Product
• Good Distribution Practice
• Good Laboratory Practice
• Good Manufacturing Practice
• 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
• Quality: Quality by Design
• Quality: Specific Types of Products
• Quality: Specifications, Analytical
Procedures and Analytical
Validation
• Quality: Stability
ICH GUIDELINES (PDF FILES)
• Q1A(R2) Stability Testing of New
Drug Substances and Products
• Q1B Stability Testing:
Photostability Testing of New Drug
Substances and Products
• Q1C Stability Testing for New
Dosage Forms
• Q1D Bracketing and Matrixing
Designs for Stability Testing of
New Drug Substances and Products
• Q1E Evaluation of Stability Data
• Q2(R1) Validation of Analytical
Procedures: Text and Methodology
• Q2(R2)/Q14 EWG Analytical
Procedure Development and
Revision of Q2 (R1) Analytical
Validation (Concept Paper)
• Q3A (R2) Impurities in New Drug
Substances
• Q3B(R2) Impurities in New Drug
Products
• Q3C(R6) Maintenance of the
Guideline for Residual Solvents
• Q3D(R1) Guideline for Elemental
Impurities
• Q4A–Q4B Pharmacopoeial
Harmonization
• Q5A(R1) Viral Safety Evaluation
of Biotechnology Products Derived
from Cell Lines of Human or
Animal Origin
• Q5B Analysis of the Expression
Construct in Cells Used for
Production of r-DNA Derived
Protein Products
• Q5C Quality of Biotechnological
Products: Stability Testing of
Biotechnological/Biological
Products
• Q5D Derivation and
Characterisation of Cell
Substrates Used for Production
of Biotechnological/Biological
Products
• Q5E Comparability of
Biotechnological/Biological
Products Subject to Changes in
their Manufacturing Process
• Q6A Specifications: Test
Procedures and Acceptance Criteria
for New Drug Substances and
New Drug Products: Chemical
Substances
• Q6B Specifications: Test
Procedures and Acceptance Criteria
for Biotechnological/Biological
Products
• Q7 Good Manufacturing Practice
Guide for Active Pharmaceutical
Ingredients
• Q8(R2) Pharmaceutical
Development
• Q9 Quality Risk Management
• Q10 Pharmaceutical Quality
System
• Q11 Development and
Manufacture of Drug Substances
• Q12 EWG Technical and
Regulatory Considerations for
Pharmaceutical Product Lifecycle
Management (Draft Guideline)
• Q13 EWG Continuous
Manufacturing of Drug Substances
and Drug Products (Concept Paper)
WORLD HEALTH
ORGANIZATION GUIDELINES
• Good Data and Records
Management (PDF)
• Generic Finished Pharmaceuticals
(PDF)
• Development of Paediatric
Medicines (PDF)
• Distribution Guidelines
• Inspection Guidelines
• Good Pharmacopoeial Practices
(PDF)
• GMPs: Main Principles (PDF)
• Stability Testing (PDF)
*Information and links current as of Dec. 7,
2019.
Catalent .............................................................25
PDA .......................................................................5
USP .....................................................................11
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