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54 BioPharm International eBook October 2020 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
• R e s u m i n g N o r m a l D r u g a n d
B i o l o g i c s M a n u f a c t u r i n g
Operations During the COVID-19
Public Health Emergency (PDF)
• Ma nu fac t u r ing, Supply Cha in,
and Drug and Biological Product
I n s p e c t ion s D u r i n g C OV I D -
19 P u bl ic He a lt h E m e r g e n c y
Questions and Answers (PDF)
• G o o d M a nu fac t u r i ng Pr ac t ice
Considerations for Responding to
COVID-19 Infection in Employees
in Drug and Biological Products
Manufacturing (PDF)
• C O V I D -1 9 P u b l i c H e a l t h
Emergency: General Considerations
for Pre-IND Meeting Requests for
COV ID-19 Related Dr ugs and
Biological Products (PDF)
• COVID-19: Developing Drugs and
Biological Products for Treatment or
Prevention (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Therapeutic Protein Products, Draft
Guidance (PDF)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)
• 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