PharmTech compiled a list of useful regulatory and compliance databases found on the web.
Searchable Databases
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
Inactive Ingredient Search for Approved Drug Products
Postmarket Requirements and Commitments
Supplier andMaterial Certification Database
ICH's Library ofPresentations and Training Materials, Concept Papers & Business Plans, Guidelines, Questions& Answers, and more.
Risk-managing training tools from the Product Quality Research Institute
USP's Medicines Quality Database
State Food and Drug Administration, P.R. China