General Regulatory Links
United States
Links to FDA email addresses regarding specific regulatory questions
> Questions about the UNII
> Corrections and questions about the IID
FDA Common Excipient Guidance Documents and Related Pages
> Search for FDA Guidance Documents
> Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate,
Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol / FDA
> Guidance for Industry Non-Clinical Studies for the Safety Evaluation of Pharmaceutical Excipients
> Guidance, Compliance, & Regulatory Information
> Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specification
> U.S. FDA Drug Master File: Guidelines
FDA Common Excipient Related Web Pages
> FDA CDER Inactive Ingredient Search (IID)
> Helpful Webinars and Other Resources for Generic Drug Manufacturers - FDA
> FDA Inspection Classification Database
> FDA Over the Counter Drug Monographs
> Food and Drug Administration Reauthorization Act of 2017 (FDARA)
> Generic Drug User Fee Amendments of 2017
> GRAS
> FDA's Global Substance Registration System
> Substance Registration System - Unique Ingredient Identifier (UNII)
> U.S. FDA Drug Master Files (DMFs) Website
> U.S. FDA Federal Register Documents, Dockets, and Daily Listings
Europe
> EU Falsified Medicines Directive, EMEA Q&A
> Annex to the European Commission guideline on "Excipients in the labeling and package leaflet of
medicinal products for human use" - European Medicines Agency (EMA)
China
> National Medical Products Administration (NMPA) English website
> Provisions for Supervision of Drug Distribution (SFDA Decree No.26)
Product Regulatory Data Sheet
Regulatory Information Compendia/Regulations
Compendia/Regulations
> British Pharmacopoeia
> Chinese Pharmacopoeia
> Certification of Suitability (CEP) - European Directorate for the Quality of Medicines & Healthcare
> EU EudraLex
> European Pharmacopoeia
> Food Chemical Codex
> Japanese Pharmacopoeia 17th Edition
> Japanese Pharmaceutical Excipients (JPE) 2018
> The International Pharmacopoeia
> US 21CFR
> USP/NF
Regulatory Information - BSE/TSE
> European Union
> Japan
> United States
Allergens
> European Union
> United States
Regulatory information – GMOs
> China (English version of the Ministry Of Health site is under construction)
> European Union
> United States
Miscellaneous
> European Medicines Agency (EMA)
• Quality Guidelines: Impurities / European Medicines Agency (EMA)
> Elemental Impurities in Drug Products Guidance for Industry / FDA
• ICHQ3D(R1)
• ICHQ3D(R2)
• ICHQ3D training
• US FDA
• EU EMA overview
> Halal:
• IFANCA-Islamic Food and Nutritional Council of America
• Muslim Consumer Group
> Kosher:
• Kosher Certification
• OU Kosher
• Star-K
> Other:
• National Organic Standards Board
• California Proposition 65
> Residual Solvents - ICH Q3C:
• ICHQ3C(R8)
• US FDA Version
• EMEA Version
Site Quality Overview
IPEC Excipient GMP Related Guidance Documents (Guides are available in the Public Library; sign in to gain access.)
Compliance evidence
> Your Food Safety Global Partners - AIB International, Inc.
Pharmaceutical Excipients Auditing
EXCiPACT
ISO International Organization for Standardization
IPEC GMP compliance details
> IPEC-PQG GMP Audit Guide for Pharmaceutical Excipients
Miscellaneous site information
> HACCP - Hazard Analysis & Critical Control Points
> Statistical Process Control/Process Analytical Technology (PAT) – Guidance
Site and Supply Chain Security Overview
Site and supply chain security
> Bio-Terrorism Act
> CFATS Chemical Facility Anti-Terrorism Standards
> C-TPAT (Customs - Trade Partnership Against Terrorism)
> Rx-360
Safety and environmental information
> ACC Responsible Care
> ISO 14000
> ISO Standards