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42 BioPharm International eBook March 2021 www.biopharminternational.com
Regulatory Sourcebook Resources
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Access key regulatory and standard setting
resources, guidance documents, and guidelines
by clicking on the title of the document.
Resources, Guidelines,
and Guidance Documents
T
he regulatory nature of the bio/
pharmaceutical industry requires
close adherence to regulations,
good manufacturing practices, and
guidelines. The websites of regulatory
authorities provide information to assist
drug development and manufacturing
organizations in navigating the regula-
tory process. This section lists infor-
mation sources to key topics; click the
appropriate link to access the online
information.The following pages list
key guidance documents from the US
Food and Drug Administration (FDA),
the European Medicines Agenc y
(EMA), and the International Council
for Harmonisation (ICH)*.
FDA RESOURCES
• FDA Human Drugs
• FDA Animal/Veterinary Drugs
• FDA Vaccines, Blood, and Biologics
• FDA Cellular & Gene Therapy
Products
• FDA Compliance Actions and
Activities
• FDA Development & Approval
Process
• FDA Drug Shortages
• FDA Guidance Documents
• FDA New Drug Approvals
• FDA Regulatory Science
• FDA Rules and Regulations
• FDA Warning Letters
US REGULATIONS
• Code of Federal Regulations, Title 21,
Food and Drugs
• Federal Register Notices Pertaining
to Drugs
COVID-19 RELATED
GUIDANCE DOCUMENTS
• COVID-19 Container Closure
System and Component Changes:
Glass Vials and Stoppers,
Guidance for Industry (PDF)
• COVID-19: Developing Drugs
and Biological Products for
Treatment or Prevention (PDF)
• COVID-19 Public Health
Emergency: General
Considerations for Pre-IND
Meeting Requests for COVID-
19 Related Drugs and Biological
Products (PDF)
• Development of Monoclonal
Antibody Products Targeting
SARS-CoV-2, Including
Addressing the Impact of
Emerging Variants, During
the COVID 19 Public Health
Emergency (PDF)
• Investigational COVID-19
Convalescent Plasma, Guidance
for Industry (PDF)
• Manufacturing, Supply Chain,
and Drug and Biological Product
Inspections During COVID-
19 Public Health Emergency
Questions and Answers (PDF)
• Good Manufacturing Practice
Considerations for Responding
to COVID-19 Infection in
Employees in Drug and Biological
Products Manufacturing (PDF)
• Resuming Normal Drug and
Biologics Manufacturing
Operations During the COVID-19
Public Health Emergency (PDF)
FDA GUIDANCE DOCUMENTS
• Analytical Procedures and
Methods Validation for Drugs
and Biologics (PDF)
• Assay Development and
Validation for Immunogenicity
Testing of Therapeutic Protein
Products, Draft Guidance (PDF)
• Assessing User Fees Under the
Biosimilar User Fee Amendments of
2017 Guidance for Industry (PDF)
• Biosimilars and Interchangeable
Biosimilars: Licensure for Fewer
Than All Conditions of Use for
Which the Reference Product
Has Been Licensed Guidance for
Industry, Draft Guidance (PDF)
• Chemistry, Manufacturing, and
Control (CMC) Information
for Human Gene Therapy
Investigational New Drug
Applications (INDs) (PDF)
• Comparability Protocols for
Human Drugs and Biologics:
Chemistry, Manufacturing, and
Controls Information Guidance
for Industry, Draft Guidance
(PDF)
• Contract Manufacturing
Arrangements for Drugs: Quality
Agreements (PDF)
• CGMP for Phase 1 Investigational
Drugs (PDF)