Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2019 53
• Adverse Event Reporting for Outsourcing
Facilities Under Section 503B of the Federal
Food, Drug, and Cosmetic Act
• ANDA Submissions–Content and Format of
Abbreviated New Drug Applications
• Elemental Impurities in Drug Products
• Labeling for Biosimilar Products
FDA Draft Guidances
• Development of Therapeutic Protein Biosimilars:
Comparative Analytical Assessment and Other
Quality-Related Considerations
• Nonproprietary Naming of Biological Products:
Update
• Quality Considerations for Continuous
Manufacturing
• Competitive Generic Therapies
• REMS Assessment: Planning and Reporting
• Biomarker Qualification: Evidentiary
Framework
• New and Revised Draft Q&As on Biosimilar
Development and the BPCI Act (Revision 2)
• Product Identifiers under the Drug Supply
Chain Security Act–Questions and Answers
• Postapproval Changes to Drug Substances
Pending Guidances
A list of the guidance documents FDA has planned
for publication can be found at www.fda.gov/
media/124386/download.
EUROPE
The following are some notable guidelines and
resources from the European Medicines Agency
(EMA)*:
EMA Website
• Pharmacovigilance Information
• Guideline Search
• Biosimilar Market Authorization
• Research and Development Information
• Marketing Authorization Information
• Post-Authorization Information
EMA Key and New Guidelines
• Guideline on the Environmental Risk Assessment
of Medicinal Products for Human Use
• Guideline on Quality, Non-Clinical and Clinical
Aspects of Medicinal Products Containing
Genetically Modified Cells
• Guideline on Similar Biological Medicinal
Products Containing Recombinant Granulocyte-
Colony Stimulating Factor (Rg-CSF)
• Questions and Answers on Bovine Spongiform
Encephalopathies (BSE) and Vaccines
• Guideline on Quality Aspects Included in the
Product Information for Vaccines for Human
Use
• Reflection Paper on the Qualification of Non-
Genotoxic Impurities
• Guideline on the Quality of Water for
Pharmaceutical Use
• Concept Paper on the Revision of the Guideline
on the Evaluation of Anticancer Medicinal
Products in Man
• Guideline on the Reporting of Physiologically
Based Pharmacokinetic (PBPK) Modelling and
Simulation
• Guideline on Active Substance Master File
Procedure Final
• Guideline on Good Pharmacovigilance
Practices (GVP) Product- or Population-
Specific Considerations IV: Paediatric
Population
• Ref lection Paper on the Use of Extrapolation
in the Development of Medicines for
Paediatrics
