Reference Center

Regulatory Reference

 

GENERAL REGULATORY - United States

Food and Drug Administration Safety and Innovation Act (FDASIA)

United States: Drug Master Files

FDA CDER Inactive Ingredient Search (IID)

UNII

FDAs Controlled Correspondence Web Page

Generic Drugs: Information for Industry (IPEC-FDA meeting minutes and relevant IID information

DMF: The Common Technical Document

 

GRAS

Guidance for Industry Non Clinical Studies for the Safety Evaluation of Pharmaceutical Excipients

FDA Inspection Classification Database

FDA's Guidance for Industry: Testing of Glycerin for Diethylene Glycol

Generic Drug User Fee Amendments of 2012

Guidance, Compliance, & Regulatory Information
US Rule making gateway:

 

 

IPEC'S REGULATORY REFERENCE GUIDANCE

> Part I-Product Regulatory Datasheet

> Part II-Site Quality Overview

> Part III- Site and Supply Chain Security Overview

> International and National Drug Sites 

PART I-PRODUCT REGULATORY DATASHEET

Regulatory Information Compendia/Regulations

COMPENDIA/REGULATIONS

USP/NF

Food Chemical Codex

EUROPEAN PHARMACOPOEIA

EDQM Certificate of Suitability

Chinese Pharmacopoeia

 

The International Pharmacopoeia

British Pharmacopoeia

Japanese Pharmacopoeia JPE

Japanese Pharmacopoeia 16

US 21CFR

EU EudraLex

 

REGULATORY INFORMATION - BSE/TSE

United States

European Union

 
Japan
 

 

ALLERGENS

 

REGULATORY INFORMATION - GMOs

United States

European Union

 
Japan

China *
* English version of the Ministry Of Health site is under construction

 

MISCELLANEOUS

Kosher:
Kosher Certification

OU Kosher

Star-K

Halal:
IFANCA-Islamic Food and Nutritional Council of America

Muslim Consumer Group

Residual Solvents - ICH Q3C:
ICH Guidelines

US FDA Version

US FDA Version Tables and List

EMEA Version

 

ICH Guidelines

ICH Guidance Documents

Other:

National Organic Standards Board

California Proposition 65

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

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PART II-SITE QUALITY OVERVIEW

IPEC Excipient GMP Related Guidance Documents

COMPLIANCE EVIDENCE

ISO International Organization for Standardization

IPEA International Pharmaceutical Excipients Auditing

 

AIB American Institute of Baking

GMA Grocery Manufacturers Association

 

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

Statistical Process Control/Process Analytical Technology (PAT) - Inititative

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PART III-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

 

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SECURITY INFORMATION

Hazardous Materials

 

SAFETY AND ENVIRONMENTAL INFORMATION

ISO 14000

ISO Standards

ACC RESPONSIBLE CARE

 

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INTERNATIONAL AND NATIONAL DRUG SITES

 

Argentina - ANMAT
Australia Therapeutic Goods Administration
Australia - Medicines Regulation
Belgium - Ministry of Social Affairs, Public Health and Environmental
Brazil - Ministry of Health
Bulgaria - National Drug Institute
Canada (Drug and Health Products)
China State Food and Drug Administration
Czech Republic - State Institute for Drug Control
Denmark: National Board of Health
Egypt - Egyptian Drug Authority

Estonia - Ravimiamet State Agency of Medicines
EU Agency for Evaluation of Medicinal Products
European Department for the Quality of Medicines-EP
Finland: National Agency for Medicines
France - French Agency for the Safelty of Health Products
Germany - Federal Institute for Drug and Medicinal Devices
Greece - National Drug Organization
Hong Kong - Department of Health
Hungary - National Institute of Pharmacy 

India - Central Drugs Standard Control Organization
International Conference on Harmonization
Ireland - Irish Medicines Board
Italy - Ministero della Salute
Japan MHW - links to International sites
Latin America - Panamerican Health Organization
Latvia - State Agency of Medicines
Luxembourg - Ministere de la Sante
Lithuania - State Medicines Control Agency
Malta - Ministry of Health
Malaysia - National Pharmaceutical Control Bureau

The Netherlands - Medicines Evaluation Board
New Zealand - Medicine Standard
New Zealand Ministry of Health
Poland - Drug Institute
Portugal-National Institute for Pharmaceutics and Medicinal Products
Saudi Food and Drug Authority
Singapore - Ministry of Health
Slovak Republic - State Institute for Drug Control
Spain - Ministerio Sanidad y Consumo Direction
Sweden - Medicinal Products Agency
Taiwan FDA
Thailand - Thailand FDA
United Kingdom - Medicines Control Agency
United States-Food and Drug Administration
WHO

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