General Regulatory Links
United States
* Links to FDA email addresses regarding specific regulatory questions
- Questions about the UNII
- Corrections and questions about the IID
- Questions about excipients in development of generic products: Controlled Correspondence
* FDA Common Excipient Guidance Documents and Related Pages
- Search for FDA Guidance Documents
- FDA's Guidance for Industry: Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol
- 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)
- FDA CDER Webinars
- 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
- 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
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
- EDQM Certificate of Suitability
- 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
Allergens
Regulatory information – GMOs
- China (English version of the Ministry Of Health site is under construction)
- European Union
- United States
Miscellaneous
- EMEA:
- Elemental Impurities, ICH Q3D:
- Halal:
- Kosher:
- Other:
- Residual Solvents - ICH Q3C:
Site Quality Overview
IPEC Excipient GMP Related Guidance Documents (Guides are available in the Document Depot, inside the Reference Center) FOR A LIST OF IPEC GUIDES - CLICK HERE!
Compliance evidence:
- AIB American Institute of Baking
- Consumer Brands Association
- EXCiPACT
- ISO International Organization for Standardization
IPEC GMP compliance details
- IPEC-PQG GMP Audit Guide for Pharmaceutical Excipients (this guide is available in the Document Depot, inside the Reference Center)
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