Regulatory References

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 for Diethylene 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


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


EU Falsified Medicines Directive, EMEA Q&A

EMA Guidelines for Excipients


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


> 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


Regulatory Information - BSE/TSE

> European Union

> Japan

> United States


> European Union

> United States

Regulatory information – GMOs

> China (English version of the Ministry Of Health site is under construction)

> European Union

> United States



Impurities - Harmonisation of Potentially Genotoxic Impurities, Heavy metal Catalysts Residues and Class 1 Solvents Residues

Elemental Impurities, ICH Q3D:

• ICHQ3D(R1)


ICHQ3D training



EU EMA overview


• IFANCA-Islamic Food and Nutritional Council of America

• Muslim Consumer Group


• Kosher Certification

OU Kosher



National Organic Standards Board

California Proposition 65

Residual Solvents - ICH Q3C:


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:

AIB American Institute of Baking

> GMA Grocery Manufacturers Association

Pharmaceutical Excipients Auditing


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