Regulatory and Compliance Databases

Apr 21, 2009
By PharmTech Editors

Searchable Databases

US FDA

Acronyms and Abbreviations

Adverse Event Reporting System (AERS)

Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)

Bioresearch Monitoring Information System (BMIS)

Clinical Investigator Inspection List (CLIIL)

Current Good Manufacturing Practice (CGMP) Regulations

Dissolution Methods for Drug Products

Drug Firm Annual Registration Status

FDA-Approved Drug Products

Guidance Documents

Inactive Ingredient Search for Approved Drug Products

Inspections Database

National Drug Code Directory

Postmarket Requirements and Commitments

Warning Letters

EDQM

Supplier and Material Certification Database

EU

EudraPharm

EudraGMP

ICH

ICH's Library of Presentations and Training Materials, Concept Papers & Business Plans, Guidelines, Questions & Answers, and more.

PQRI

Risk-managing training tools from the Product Quality Research Institute

USP

USP's Medicines Quality Database

SFDA

State Food and Drug Administration, P.R. China