www.biopharminternational.com March 2020 BioPharm International eBook 51
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 guide-
lines. The websites of regulatory authori-
ties provide information to assist drug
development and manufacturing orga-
nizations in navigating the regulatory
process. This section lists information
sources to key topics; click the appropri-
ate link to access the online information.
The following pages list key guid-
ance documents f rom the US Food
and Drug Administration (FDA), the
European Medicines Agency (EMA),
the Wor ld Health O rganiz ation
(WHO), 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
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Therapeutic Protein Products, Draft
Guidance (PDF)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Industry, Draft Guidance (PDF)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Draft Guidance (PDF)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)
• Current Good Manufacturing
Practice for Phase 1 Investigational
Drugs (PDF)
• Data Integrity and Compliance
With Current Good Manufacturing
Practice Guidance for Industry
(PDF)
• Demonstrating Substantial Evidence
of Effectiveness 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
• Human Gene Therapy for Rare
Diseases (PDF)
• Importation of Certain FDA-
Approved Human Prescription
Drugs, Including Biological Products,
under Section 801(d)(1)(B) of the
Federal Food, Drug, and Cosmetic
Act, Draft Guidance (PDF)
• INDs for Phase 2 and Phase 3
Studies Chemistry, Manufacturing,
and Controls Information (PDF)
• Long Term Follow-up After
Administration of Human Gene
Therapy Products
• PAT — A Framework for Innovative
Pharmaceutical Development,
Manufacturing, and Quality
Assurance (PDF)
• Postapproval Changes to Drug
Substances Guidance for Industry,
Draft Guidance (PDF)
